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Prescribing Information
FLUMIST®

FluMist

(influenza vaccine live intranasal)

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Highlights of Prescribing Information

<?xml version="1.0" encoding="UTF-8"?><title>These highlights do not include all the information needed to use FLUMIST<sup>®</sup> safely and effectively. See full prescribing information for FLUMIST.<br/> <br/>FluMist (Influenza Vaccine Live, Intranasal)<br/>Nasal Spray, for intranasal use<br/>2025-2026 Formula<br/>Initial U.S. Approval: 2003<br/> </title>

SPL product data elements section
RECENT MAJOR CHANGES SECTION
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
13 NONCLINICAL TOXICOLOGY
14 CLINICAL STUDIES
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
Patient Package Insert
SPL UNCLASSIFIED SECTION
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Package/Label Display Panel

SPL product data elements section

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<?xml version="1.0" encoding="UTF-8"?><section ID="ID_ef006f6e-b0a3-438f-8943-038d667ad65c"> <id root="1baeaf81-ed2d-4af7-869a-82ed1fd744c1"/> <code code="43683-2" codeSystem="2.16.840.1.113883.6.1" displayName="RECENT MAJOR CHANGES SECTION"/> <effectiveTime value="20250701"/> <excerpt> <highlight> <text> <paragraph/> <paragraph>Dosage and Administration (<linkHtml href="#ID_50912d9b-ef10-437f-abee-6f7b019be138">2.2</linkHtml>) 09/2024</paragraph> <paragraph>Warnings and Precautions (<linkHtml href="#ID_2a00e148-c947-4132-ab20-2c13df5e8d34">5.6</linkHtml>) 09/2024</paragraph> </text> </highlight> </excerpt> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="_1_INDICATIONS_AND"> <id root="663b0952-b2a0-4e1a-86ff-6f4fc10c8475"/> <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS & USAGE SECTION"/> <title>1 INDICATIONS AND USAGE</title> <text> <paragraph>FluMist is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine <content styleCode="italics">[see <linkHtml href="#_11_DESCRIPTION">Description (11)</linkHtml>]</content>.</paragraph> <paragraph>FluMist is approved for use in persons 2 through 49 years of age.</paragraph> </text> <effectiveTime value="20250701"/> <excerpt> <highlight> <text> <paragraph>FluMist is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. (<linkHtml href="#_1_INDICATIONS_AND">1</linkHtml>, <linkHtml href="#_11_DESCRIPTION">11</linkHtml>)</paragraph> <paragraph>FluMist is approved for use in persons 2 through 49 years of age. (<linkHtml href="#_1_INDICATIONS_AND">1</linkHtml>)</paragraph> </text> </highlight> </excerpt> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="_2_DOSAGE_AND"> <id root="fe774188-89df-4369-83e6-878aaa18e7b5"/> <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE & ADMINISTRATION SECTION"/> <title>2 DOSAGE AND ADMINISTRATION</title> <text> <paragraph> <content styleCode="bold">For intranasal use.</content> </paragraph> </text> <effectiveTime value="20250701"/> <excerpt> <highlight> <text> <paragraph>For intranasal use. <linkHtml href="#_2_DOSAGE_AND">(2)</linkHtml> </paragraph> <table width="86.76%"> <col width="30%"/> <col width="28%"/> <col width="42%"/> <tbody> <tr> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Age</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Dose</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Schedule</content> </paragraph> </td> </tr> <tr> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>2 years through 8 years</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1 or 2 doses<footnote ID="_Ref514753598">1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines.</footnote>,</paragraph> <paragraph>0.2 mL<footnote ID="_Ref514753742">Administer as 0.1 mL per nostril.</footnote> each</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>If 2 doses, administer at least 1 month apart</paragraph> </td> </tr> <tr> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>9 years through 49 years</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1 dose, 0.2 mL<footnoteRef IDREF="_Ref514753742"/> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>-</paragraph> </td> </tr> <tr> <td align="justify" colspan="3" styleCode="Botrule Toprule " valign="top"> <paragraph>“-” indicates information is not applicable.</paragraph> </td> </tr> </tbody> </table> </text> </highlight> </excerpt> <component> <section ID="ID_5ba02f82-f513-438a-8f86-ed23d8ae3e0a"> <id root="ea4768f5-508d-4d82-ba91-0fe8e54bad99"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>2.1 Dosing Information</title> <text> <paragraph>Administer FluMist according to the following schedule:</paragraph> <table width="86.76%"> <col width="30%"/> <col width="27%"/> <col width="42%"/> <tbody> <tr> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Age</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Dose</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Schedule</content> </paragraph> </td> </tr> <tr> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>2 years through 8 years</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1 or 2 doses<footnote ID="_Ref497478030">1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines.</footnote>,<br/>0.2 mL<footnote ID="_Ref497478054">Administer as 0.1 mL per nostril.</footnote> <sup> </sup>each</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>If 2 doses, administer at least 1 month apart</paragraph> </td> </tr> <tr> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>9 years through 49 years</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1 dose, 0.2 mL<footnoteRef IDREF="_Ref497478054"/> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>-</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Toprule " valign="top"> <paragraph>“-” indicates information is not applicable.</paragraph> </td> </tr> </tbody> </table> </text> <effectiveTime value="20250701"/> </section> </component> <component> <section ID="ID_50912d9b-ef10-437f-abee-6f7b019be138"> <id root="da9d8e0b-4873-4ece-811f-1f069f2beead"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>2.2 Administration Instructions</title> <text> <paragraph> <content styleCode="xmChange">Each sprayer contains a single dose (0.2 mL) of FluMist; administer approximately one half of the contents of the single-dose intranasal sprayer into each nostril.</content> </paragraph> <paragraph> <content styleCode="xmChange">When administered by a healthcare provider in a healthcare setting, refer to Figure 1 for step-by-step administration instructions. Following administration, dispose of the sprayer according to the standard procedures for medical waste (e.g., sharps container or biohazard container).</content> </paragraph> <paragraph> <content styleCode="xmChange">Instruct vaccine recipients or caregivers who administer FluMist to follow the directions provided in the “Instructions for Use” for administration and disposal of FluMist. Individuals 2 through 17 years of age should not self‑administer FluMist.</content> </paragraph> <paragraph> <content styleCode="bold">Figure 1</content> </paragraph> <renderMultiMedia ID="id444" referencedObject="ID_7d323dbd-aa73-4e7b-ba41-9aad29b11b5a"/> </text> <effectiveTime value="20250701"/> <component> <observationMedia ID="ID_7d323dbd-aa73-4e7b-ba41-9aad29b11b5a"> <text>figure_1</text> <value mediaType="image/jpeg"> <reference value="figure_1.jpg"/> </value> </observationMedia> </component> </section> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="_3_DOSAGE_FORMS"> <id root="2d19e1da-9835-4078-80a4-113d26d05a31"/> <code code="43678-2" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE FORMS & STRENGTHS SECTION"/> <title>3 DOSAGE FORMS AND STRENGTHS</title> <text> <paragraph>FluMist is a nasal spray. A single dose is 0.2 mL.</paragraph> </text> <effectiveTime value="20250701"/> <excerpt> <highlight> <text> <paragraph>FluMist is a nasal spray. A single dose is 0.2 mL. (<linkHtml href="#_3_DOSAGE_FORMS">3</linkHtml>)</paragraph> </text> </highlight> </excerpt> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_69f4c6e8-b931-4bae-a123-d5f9060fb985"> <id root="5e89e6e5-2993-454f-ad7d-ffdba3529dee"/> <code code="34070-3" codeSystem="2.16.840.1.113883.6.1" displayName="CONTRAINDICATIONS SECTION"/> <title>4 CONTRAINDICATIONS </title> <effectiveTime value="20250701"/> <excerpt> <highlight> <text> <list listType="unordered"> <item> <caption>•</caption>Do not administer FluMist to persons who have had a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine including egg protein, or after a previous dose of any influenza vaccine. (<linkHtml href="#_4_1_Severe_Allergic">4.1</linkHtml>, <linkHtml href="#_11_DESCRIPTION">11</linkHtml>)</item> <item> <caption>•</caption>Do not administer FluMist to children and adolescents through 17 years of age who are receiving aspirin therapy or aspirin-containing therapy. (<linkHtml href="#_4_2_Concomitant_Aspirin">4.2</linkHtml>, <linkHtml href="#_7_1_Aspirin_Therapy">7.1</linkHtml>)</item> </list> </text> </highlight> </excerpt> <component> <section ID="_4_1_Severe_Allergic"> <id root="9b194ffb-846c-485a-9d4e-c3adf25fc8e3"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>4.1 Severe Allergic Reactions</title> <text> <paragraph>Do not administer FluMist to persons who have had a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine <content styleCode="italics">[see <linkHtml href="#_11_DESCRIPTION">Description (11)</linkHtml>]</content> including egg protein, or after a previous dose of any influenza vaccine.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> <component> <section ID="_4_2_Concomitant_Aspirin"> <id root="511f2597-75d5-4d25-9a90-e78a5698b3d8"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>4.2 Concomitant Aspirin Therapy and Reye’s Syndrome in Children and Adolescents</title> <text> <paragraph>Do not administer FluMist to children and adolescents through 17 years of age who are receiving aspirin therapy or aspirin-containing therapy because of the association of Reye’s syndrome with aspirin and wild-type influenza infection <content styleCode="italics">[see <linkHtml href="#_7_1_Aspirin_Therapy">Drug Interactions (7.1)</linkHtml>]</content>.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_74873b4e-885e-45f6-8909-681bf23f6d90"> <id root="b594327b-052b-4609-a10f-ddf4bd8e8cef"/> <code code="43685-7" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS AND PRECAUTIONS SECTION"/> <title>5 WARNINGS AND PRECAUTIONS</title> <effectiveTime value="20250801"/> <excerpt> <highlight> <text> <list listType="unordered"> <item> <caption>•</caption>In clinical trials, risks of hospitalization and wheezing were increased in children younger than 2 years of age who received FluMist. <linkHtml href="#_5_1_Risks_of">(5.1)</linkHtml> </item> <item> <caption>•</caption>Children younger than 5 years of age with recurrent wheezing and persons of any age with asthma may be at increased risk of wheezing following the administration of FluMist. <linkHtml href="#_5_2_Asthma__Recurrent">(5.2)</linkHtml> </item> <item> <caption>•</caption>If Guillain-Barré syndrome has occurred within 6 weeks of any prior influenza vaccination, the decision to give FluMist should be based on careful consideration of the potential benefits and risks. <linkHtml href="#_5_3__">(5.3)</linkHtml> </item> </list> </text> </highlight> </excerpt> <component> <section ID="_5_1_Risks_of"> <id root="815ece90-0a85-42bb-b51b-22cc0f28d179"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>5.1 Risks of Hospitalization and Wheezing in Children Younger than 24 Months of Age</title> <text> <paragraph>In clinical trials, risks of hospitalization and wheezing were increased in children younger than 2 years of age who received FluMist <content styleCode="italics">[see</content> <content styleCode="italics"> <linkHtml href="#_6_1_Clinical_Trials">Adverse Reactions (6.1)</linkHtml>]</content>.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> <component> <section ID="_5_2_Asthma__Recurrent"> <id root="644ab176-3294-4c53-8fc1-e758b90d42b8"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>5.2 Asthma, Recurrent Wheezing, and Active Wheezing</title> <text> <paragraph>Children younger than 5 years of age with recurrent wheezing and persons of any age with asthma may be at increased risk of wheezing following administration of FluMist. FluMist has not been studied in persons with severe asthma or active wheezing.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> <component> <section ID="_5_3__"> <id root="8278d838-536c-4a5a-a1e0-caaef623dd37"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>5.3 Guillain-Barré Syndrome</title> <text> <paragraph>If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of any prior influenza vaccination, the decision to give FluMist should be based on careful consideration of the potential benefits and potential risks.</paragraph> <paragraph>The 1976 swine influenza vaccine (inactivated) was associated with an elevated risk of GBS. Evidence for causal relation of GBS with other influenza vaccines is inconclusive; if an excess risk exists, based on data for inactivated influenza vaccines, it is probably slightly more than 1 additional case per 1 million persons vaccinated<linkHtml href="#ID_a4fdd1b6-3848-484c-a298-12c101e81987">1</linkHtml>.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> <component> <section ID="_5_4__"> <id root="1fe65bf2-cc92-4435-97e5-ec5626a5082a"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>5.4 Altered Immunocompetence</title> <text> <paragraph>The effectiveness of FluMist has not been studied in immunocompromised persons. Data on safety and shedding of vaccine virus after administration of FluMist in immunocompromised persons are limited to 173 persons with HIV infection and 10 mild to moderately immunocompromised children and adolescents with cancer <content styleCode="italics">[see <linkHtml href="#_12_2_Pharmacodynamics">Clinical Pharmacology (12.2)</linkHtml>]</content>.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> <component> <section ID="ID_6c3f59a8-a2bc-46a4-bda7-e9ff1ca059da"> <id root="8c6ad81f-a02d-4665-808d-ada2c82b38a2"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>5.5 Medical Conditions Predisposing to Influenza Complications</title> <text> <paragraph>The safety of FluMist in individuals with underlying medical conditions that may predispose them to complications following wild-type influenza infection has not been established.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> <component> <section ID="ID_2a00e148-c947-4132-ab20-2c13df5e8d34"> <id root="46796044-437a-4c7f-bc71-8bde2b3b6758"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>5.6 Management of Acute Allergic Reactions</title> <text> <paragraph> <content styleCode="xmChange">When administered by a healthcare provider in a healthcare setting, appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of FluMist <content styleCode="italics">[see </content> </content> <content styleCode="bold">Error! Hyperlink reference not valid.</content> <content styleCode="xmChange"> <content styleCode="italics">]</content>.</content> </paragraph> <paragraph> <content styleCode="xmChange">When FluMist is self-administered or administered by a caregiver, immediate medical attention should be sought if the vaccine recipient experiences symptoms of an allergic reaction following administration of FluMist.</content> </paragraph> </text> <effectiveTime value="20250801"/> </section> </component> <component> <section ID="ID_b7ec4224-2055-403e-b192-de96f974a464"> <id root="183fe461-afd6-42e1-b735-51b0cbbdc138"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>5.7 Limitations of Vaccine Effectiveness</title> <text> <paragraph>FluMist may not protect all individuals receiving the vaccine.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_82b1a881-314b-44c0-aab0-3f99aa6d00cd"> <id root="f821f440-969b-45ab-ba08-cb5c650da085"/> <code code="34084-4" codeSystem="2.16.840.1.113883.6.1" displayName="ADVERSE REACTIONS SECTION"/> <title>6 ADVERSE REACTIONS</title> <text> <paragraph>The most common solicited adverse reactions (≥10% in vaccine recipients and at least 5% greater than in placebo recipients) reported after FluMist were runny nose or nasal congestion (ages 2 years through 49 years), fever over 100°F (children ages 2 years through 6 years), and sore throat (adults ages 18 years through 49 years).</paragraph> </text> <effectiveTime value="20250701"/> <excerpt> <highlight> <text> <paragraph>The most common solicited adverse reactions (≥10% in vaccine recipients and at least 5% greater than in placebo recipients) reported after FluMist were runny nose or nasal congestion (ages 2 years through 49 years), fever over 100°F (children ages 2 years through 6 years), and sore throat (adults ages 18 years through 49 years). (<linkHtml href="#_6_1_Clinical_Trials">6.1</linkHtml>)<br/> <br/> </paragraph> <paragraph> <content styleCode="bold">To report SUSPECTED ADVERSE REACTIONS, contact MedImmune at 1-877-633-4411 or VAERS at 1-800-822-7967 or <linkHtml href="http://vaers.hhs.gov">http://vaers.hhs.gov</linkHtml>.</content> </paragraph> </text> </highlight> </excerpt> <component> <section ID="_6_1_Clinical_Trials"> <id root="4492e214-c81e-417a-9a96-21cadfed3a81"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>6.1 Clinical Trials Experience</title> <text> <paragraph>Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.</paragraph> <paragraph>A total of 9537 children and adolescents 1 through 17 years of age and 3041 adults 18 through 64 years of age received FluMist in randomized, placebo-controlled Studies D153-P501, AV006, D153-P526, AV019, and AV009 [3 used Allantoic Fluid containing Sucrose-Phosphate-Glutamate (AF-SPG) placebo, and 2 used saline placebo] described below. In addition, 4179 children 6 through 59 months of age received FluMist in Study MI-CP111, a randomized, active-controlled trial. Among pediatric FluMist recipients 6 months through 17 years of age, 50% were female; in the study of adults, 55% were female. In MI-CP111, AV006, D153-P526, AV019, and AV009, subjects were White (71%), Hispanic (11%), Asian (7%), Black (6%), and Other (5%), while in D153-P501, 99% of subjects were Asian.</paragraph> <paragraph> <content styleCode="bold"> <content styleCode="italics"> <content styleCode="underline">FluMist in Children and Adolescents</content> </content> </content> </paragraph> <paragraph>The safety of FluMist was evaluated in an AF-SPG placebo-controlled Study (AV019) conducted in a Health Maintenance Organization (HMO) in children 1 through 17 years of age (FluMist = 6473, placebo = 3216). An increase in asthma events, captured by review of diagnostic codes, was observed in children younger than 5 years of age who received FluMist compared to those who received placebo (Relative Risk 3.53, 90% CI: 1.1, 15.7).</paragraph> <paragraph>In Study MI-CP111, children 6 through 59 months of age were randomized to receive FluMist or inactivated Influenza Virus Vaccine manufactured by Sanofi Pasteur Inc. Wheezing requiring bronchodilator therapy or accompanied by respiratory distress or hypoxia was prospectively monitored from randomization through 42 days post last vaccination. Hospitalization due to all causes was prospectively monitored from randomization through 180 days post last vaccination. Increases in wheezing and hospitalization (for any cause) were observed in children 6 months through 23 months of age who received FluMist compared to those who received inactivated Influenza Virus Vaccine, as shown in Table 1.</paragraph> <table ID="table1" styleCode="Noautorules" width="100%"> <caption>Table 1: Percentages of Children with Hospitalizations and Wheezing from Study MI-CP111<footnote ID="_Ref497470475">NCT00128167; see <linkHtml href="https://www.clinicaltrials.gov/">www.clinicaltrials.gov</linkHtml>.</footnote> </caption> <col width="27%"/> <col width="24%"/> <col width="25%"/> <col width="25%"/> <tbody> <tr> <td styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Adverse Reaction</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Age Group</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">FluMist</content> <br/> <content styleCode="bold">(n/N)</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Active Control</content> <footnote ID="_Ref497470498">Inactivated Influenza Virus Vaccine manufactured by Sanofi Pasteur Inc., administered intramuscularly.</footnote> <br/> <content styleCode="bold">(n/N)</content> </paragraph> </td> </tr> <tr> <td rowspan="2" styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>Hospitalizations<footnote ID="_Ref497470513">Hospitalization due to any cause from randomization through 180 days post last vaccination.</footnote> <br/> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 6-23 months</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 4.2%<br/>(84/1992)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 3.2%<br/>(63/1975)</paragraph> </td> </tr> <tr> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 24-59 months</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 2.1%<br/>(46/2187)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 2.5%<br/>(56/2198)</paragraph> </td> </tr> <tr> <td rowspan="2" styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>Wheezing<footnote ID="_Ref497470519">Wheezing requiring bronchodilator therapy or accompanied by respiratory distress or hypoxia evaluated from randomization through 42 days post last vaccination.</footnote> <br/> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 6-23 months</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 5.9%<br/>(117/1992)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 3.8%<br/>(75/1975)</paragraph> </td> </tr> <tr> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> 24-59 months</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> 2.1%<br/>(47/2187)</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> 2.5%<br/>(56/2198)</paragraph> </td> </tr> </tbody> </table> <paragraph>Most hospitalizations observed were due to gastrointestinal and respiratory tract infections and occurred more than 6 weeks post vaccination. In post-hoc analysis, rates of hospitalization in children 6 through 11 months of age were 6.1% (42/684) in FluMist recipients and 2.6% (18/683) in inactivated Influenza Virus Vaccine recipients.</paragraph> <paragraph>Table 2 shows pooled solicited adverse reactions occurring in at least 1% of FluMist recipients and at a higher rate (≥1% rate difference after rounding) compared to placebo post Dose 1 for Studies D153-P501 and AV006, and solicited adverse reactions post Dose 1 for Study MI-CP111. Solicited adverse reactions were those about which parents/guardians were specifically queried after receipt of FluMist, placebo, or control vaccine. In these studies, solicited reactions were documented for 10 days post vaccination. Solicited reactions following the second dose of FluMist were similar to those following the first dose and were generally observed at a lower frequency.</paragraph> <table ID="table2" width="100%"> <caption>Table 2: Summary of Solicited Adverse Reactions Observed Within 10 Days after Dose 1 for FluMist and Either Placebo or Active Control Recipients in Children 2 through 6 Years of Age</caption> <col width="26%"/> <col width="14%"/> <col width="20%"/> <col width="20%"/> <col width="20%"/> <tbody> <tr> <td styleCode="Rrule Botrule Lrule Toprule " valign="top"/> <td colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Studies D153-P501</content> <footnote ID="_Ref40761587">NCT00192244; see <linkHtml href="https://www.clinicaltrials.gov/">www.clinicaltrials.gov</linkHtml>.</footnote> <content styleCode="bold"> & AV006</content> </paragraph> </td> <td align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Study MI-CP111</content> <footnote ID="_Ref497470615">NCT00128167; see <linkHtml href="https://www.clinicaltrials.gov/">www.clinicaltrials.gov</linkHtml>.</footnote> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"/> <td align="center" valign="top"> <paragraph> <content styleCode="bold">FluMist</content> </paragraph> </td> <td align="center" valign="top"> <paragraph> <content styleCode="bold">Placebo</content> <footnote ID="_Ref497470623">Study D153-P501 used saline placebo; Study AV006 used AF-SPG placebo.</footnote> </paragraph> </td> <td align="center" valign="top"> <paragraph> <content styleCode="bold">FluMist</content> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Active Control</content> <footnote ID="_Ref497470631">Inactivated Influenza Virus Vaccine manufactured by Sanofi Pasteur Inc., administered intramuscularly.</footnote> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td align="center" valign="top"> <paragraph> <content styleCode="bold">N = 876-1759</content> <footnote ID="_Ref497470640">Number of evaluable subjects (those who returned diary cards) for each reaction. Range reflects differences in data collection between the 2 pooled studies.</footnote> </paragraph> </td> <td align="center" valign="top"> <paragraph> <content styleCode="bold">N = 424-1034</content> <footnoteRef IDREF="_Ref497470640"/> </paragraph> </td> <td align="center" valign="top"> <paragraph> <content styleCode="bold">N = 2170</content> <footnoteRef IDREF="_Ref497470640"/> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">N = 2165</content> <footnoteRef IDREF="_Ref497470640"/> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Event</content> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>%</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>%</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> %</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>%</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Runny Nose/<br/> Nasal Congestion</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> <br/>58</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> <br/>50</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> <br/>51</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> <br/>42</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Decreased Appetite</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>21</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>17</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>13</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>12</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Irritability</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>21</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>19</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>12</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>11</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Decreased Activity<br/>(Lethargy) </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>14</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>11</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>7</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>6</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Sore Throat</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>11</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>9</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>5</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>6</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Headache</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>9</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>7</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>3</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Muscle Aches</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>6</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>2</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Chills</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>4</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>2</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Fever</paragraph> </td> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"/> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"/> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"/> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>> 100°F Oral<br/>> 100 - ≤ 101°F Oral <br/>> 101 - ≤ 102°F Oral</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>16<br/>9<br/>4</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>11<br/>6<br/>3</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>13<br/>6<br/>4</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>11<br/>4<br/>3</paragraph> </td> </tr> </tbody> </table> <paragraph>In clinical studies D153-P501 and AV006, unsolicited adverse reactions in children occurring in at least 1% of FluMist recipients and at a higher rate (≥1% rate difference after rounding) compared to placebo were abdominal pain (2% FluMist vs. 0% placebo) and otitis media (3% FluMist vs. 1% placebo). An additional adverse reaction identified in the active-controlled trial MI-CP111 occurring in at least 1% of FluMist recipients and at a higher rate (≥1% rate difference after rounding) compared to active control was sneezing (2% FluMist vs.1% active control).</paragraph> <paragraph>In a separate saline placebo-controlled trial (D153-P526) in a subset of older children and adolescents 9 through 17 years of age who received one dose of FluMist, the solicited adverse reactions as well as unsolicited adverse reactions reported were generally consistent with observations from the trials in Table 2.<content styleCode="bold"> <content styleCode="italics"> </content> </content>Abdominal pain was reported in 12% of FluMist recipients compared to 4% of placebo recipients and decreased activity was reported in 6% of FluMist recipients compared to 0% of placebo recipients.</paragraph> <paragraph>In Study AV018, in which FluMist was concomitantly administered with Measles, Mumps, and Rubella Virus Vaccine Live (MMR, manufactured by Merck & Co., Inc.) and Varicella Virus Vaccine Live (manufactured by Merck & Co., Inc.) to children 12 through 15 months of age, adverse reactions were similar to those seen in other clinical trials of FluMist.</paragraph> <paragraph> <content styleCode="bold"> <content styleCode="italics"> <content styleCode="underline">FluMist in Adults</content> </content> </content> </paragraph> <paragraph>In adults 18 through 49 years of age in Study AV009, solicited adverse reactions occurring in at least 1% of FluMist recipients and at a higher rate (≥1% rate difference after rounding) compared to AF-SPG placebo include runny nose (44% FluMist vs. 27% placebo), headache (40% FluMist vs. 38% placebo), sore throat (28% FluMist vs. 17% placebo), tiredness/weakness (26% FluMist vs. 22% placebo), muscle aches (17% FluMist vs. 15% placebo), cough (14% FluMist vs. 11% placebo), and chills (9% FluMist vs. 6% placebo).</paragraph> <paragraph>In Study AV009, unsolicited adverse reactions occurring in at least 1% of FluMist recipients and at a higher rate (≥1% rate difference after rounding) compared to placebo were nasal congestion (9% FluMist vs. 2% placebo) and sinusitis (4% FluMist vs. 2% placebo).</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> <component> <section ID="ID_9abcb679-cf3d-4870-ad8c-1a857a4aef6a"> <id root="b0f6b137-1336-4e2a-bd6b-4923a16bf9b7"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>6.2 Postmarketing Experience </title> <text> <paragraph>The following events have been spontaneously reported during post approval use of FluMist or FluMist Quadrivalent. Data for FluMist Quadrivalent are relevant to FluMist because both vaccines are manufactured using the same process and have overlapping compositions. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.</paragraph> <paragraph>Cardiac disorders: Pericarditis</paragraph> <paragraph>Congenital, familial, and genetic disorders: Exacerbation of symptoms of mitochondrial encephalomyopathy (Leigh syndrome)</paragraph> <paragraph>Gastrointestinal disorders: Nausea, vomiting, diarrhea</paragraph> <paragraph>Immune system disorders: Hypersensitivity reactions (including anaphylactic reaction, facial edema, and urticaria)</paragraph> <paragraph>Nervous system disorders: Guillain-Barré syndrome, Bell’s Palsy, meningitis, eosinophilic meningitis, vaccine-associated encephalitis, syncope</paragraph> <paragraph>Respiratory, thoracic, and mediastinal disorders: Epistaxis</paragraph> <paragraph>Skin and subcutaneous tissue disorders: Rash</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_c4056bc4-3b88-44e2-9aa3-a058300621c4"> <id root="890a123a-eadc-49d5-86da-c0f5805e7f77"/> <code code="34073-7" codeSystem="2.16.840.1.113883.6.1" displayName="DRUG INTERACTIONS SECTION"/> <title>7 DRUG INTERACTIONS</title> <effectiveTime value="20250701"/> <excerpt> <highlight> <text> <paragraph>Antiviral drugs that are active against influenza A and/or B may reduce the effectiveness of FluMist if administered within 48 hours before, or within 2 weeks after, receipt of the vaccine. <linkHtml href="#_7_2__">(7.2)</linkHtml> </paragraph> </text> </highlight> </excerpt> <component> <section ID="_7_1_Aspirin_Therapy"> <id root="6b18f201-246f-4f50-a81f-58b215f89485"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>7.1 Aspirin Therapy</title> <text> <paragraph>Do not administer FluMist to children and adolescents through 17 years of age who are receiving aspirin therapy or aspirin-containing therapy because of the association of Reye’s syndrome with aspirin and wild-type influenza <content styleCode="italics">[see <linkHtml href="#_4_2_Concomitant_Aspirin">Contraindications (4.2)</linkHtml>]</content>. Avoid aspirin-containing therapy in these age groups during the first 4 weeks after vaccination with FluMist unless clearly needed.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> <component> <section ID="_7_2__"> <id root="a39881e8-dabf-4c3e-b246-abe89edae463"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>7.2 Antiviral Agents Against Influenza A and/or B</title> <text> <paragraph>Antiviral drugs that are active against influenza A and/or B viruses may reduce the effectiveness of FluMist if administered within 48 hours before, or within 2 weeks after vaccination. The concurrent use of FluMist with antiviral agents that are active against influenza A and/or B viruses has not been evaluated. If antiviral agents and FluMist are administered concomitantly, revaccination should be considered when appropriate.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_972fd21a-4adc-456d-b6a4-d9a5aab4dc2f"> <id root="e5863058-a6e9-4c5b-a3d5-174597b2313a"/> <code code="43684-0" codeSystem="2.16.840.1.113883.6.1" displayName="USE IN SPECIFIC POPULATIONS SECTION"/> <title>8 USE IN SPECIFIC POPULATIONS</title> <effectiveTime value="20250701"/> <excerpt> <highlight> <text> <paragraph>In clinical trials, in children 6 through 23 months of age, FluMist was associated with an increased risk of hospitalization and wheezing. <linkHtml href="#_8_4__">(8.4)</linkHtml> </paragraph> </text> </highlight> </excerpt> <component> <section ID="_8_1_Pregnancy"> <id root="08f21f66-85eb-47a9-8104-af2d40997d05"/> <code code="42228-7" codeSystem="2.16.840.1.113883.6.1" displayName="PREGNANCY SECTION"/> <title>8.1 Pregnancy</title> <text> <paragraph> <content styleCode="underline">Risk Summary</content> </paragraph> <paragraph>FluMist is not absorbed systemically following intranasal administration and maternal use is not expected to result in fetal exposure to the drug.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> <component> <section ID="ID_f7f337e4-d475-4ad4-8a98-0e2c93214b22"> <id root="4884a96c-110b-46c3-ad41-8360c66d9c91"/> <code code="77290-5" codeSystem="2.16.840.1.113883.6.1" displayName="LACTATION SECTION"/> <title>8.2 Lactation</title> <text> <paragraph> <content styleCode="underline">Risk Summary</content> </paragraph> <paragraph>FluMist is not absorbed systemically by the mother following intranasal administration and breastfeeding is not expected to result in exposure of the child to FluMist.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> <component> <section ID="_8_4__"> <id root="5a6c98fc-a0cb-4fa9-be86-b87df387ded8"/> <code code="34081-0" codeSystem="2.16.840.1.113883.6.1" displayName="PEDIATRIC USE SECTION"/> <title>8.4 Pediatric Use</title> <text> <paragraph>FluMist is not approved for use in children younger than 24 months of age because use of FluMist in children 6 through 23 months has been associated with increased risks of hospitalization and wheezing in clinical trials <content styleCode="italics">[see <linkHtml href="#_5_1_Risks_of">Warnings and Precautions (5.1)</linkHtml> and <linkHtml href="#_6_1_Clinical_Trials">Adverse Reactions (6.1)</linkHtml>].</content> </paragraph> <paragraph>The effectiveness of FluMist in children 6 years through 17 years of age is supported by demonstration of efficacy in younger children 6 through 71 months of age and effectiveness in adults 18 through 49 years of <content styleCode="italics">age [see <linkHtml href="#_14_CLINICAL_STUDIES">Clinical Studies (14)</linkHtml>]</content>.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> <component> <section ID="_8_5__"> <id root="0cb5165c-370b-4f33-80f2-d5b4117657c3"/> <code code="34082-8" codeSystem="2.16.840.1.113883.6.1" displayName="GERIATRIC USE SECTION"/> <title>8.5 Geriatric Use</title> <text> <paragraph>FluMist is not approved for use in persons 65 years of age and older because in a clinical study (AV009), effectiveness of FluMist to prevent febrile illness was not demonstrated in adults 50 through 64 years of age<content styleCode="italics"> [see </content> <content styleCode="italics"> <linkHtml href="#_14_3_Effectiveness_Study">Clinical Studies (14.2)</linkHtml> </content> <content styleCode="italics">]</content>. In this study, solicited events among individuals 50 through 64 years of age were similar in type and frequency to those reported in younger adults. In a clinical study of FluMist in persons 65 years of age and older, subjects with underlying high-risk medical conditions (N = 200) were studied for safety. Compared to controls, FluMist recipients had a higher rate of sore throat.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="_11_DESCRIPTION"> <id root="1203d9bb-88f4-4cb7-a28c-be216febbb04"/> <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/> <title>11 DESCRIPTION</title> <text> <paragraph>FluMist (Influenza Vaccine Live, Intranasal) is a nasal spray. FluMist contains three vaccine virus strains: an A/H1N1 strain, an A/H3N2 strain and a B strain from the B/Victoria lineage.</paragraph> <paragraph>The influenza virus strains in FluMist are (a) <content styleCode="italics">cold-adapted</content> (<content styleCode="italics">ca</content>) (i.e., they replicate efficiently at 25°C, a temperature that is restrictive for replication of many wild-type influenza viruses); (b) <content styleCode="italics">temperature-sensitive </content>(<content styleCode="italics">ts</content>) (i.e., they are restricted in replication at 37°C (Type B strain) or 39°C (Type A strains), temperatures at which many wild-type influenza viruses grow efficiently); and (c) <content styleCode="italics">attenuated </content>(<content styleCode="italics">att</content>) (i.e., they do not produce classic influenza-like illness in the ferret model of human influenza infection).</paragraph> <paragraph>No evidence of reversion has been observed in the recovered vaccine strains that have been tested (135 of possible 250 recovered isolates) using FluMist <content styleCode="italics">[see <linkHtml href="#_12_2_Pharmacodynamics">Clinical Pharmacology (12.2)</linkHtml>]</content>. For each of the three reassortant strains in FluMist, the six internal gene segments responsible for <content styleCode="italics">ca</content>, <content styleCode="italics">ts</content>, and <content styleCode="italics">att</content> phenotypes are derived from a master donor virus (MDV), and the two segments that encode the two surface glycoproteins, hemagglutinin (HA) and neuraminidase (NA), are derived from the corresponding antigenically relevant wild-type influenza viruses. Thus, the three viruses contained in FluMist maintain the replication characteristics and phenotypic properties of the MDV and express the HA and NA of wild-type viruses. For the Type A MDV, at least five genetic loci in three different internal gene segments contribute to the <content styleCode="italics">ts</content> and <content styleCode="italics">att </content>phenotypes. For the Type B MDV, at least three genetic loci in two different internal gene segments contribute to both the <content styleCode="italics">ts</content> and <content styleCode="italics">att </content>properties; five genetic loci in three gene segments control the <content styleCode="italics">ca</content> property.</paragraph> <paragraph>Each of the reassortant strains in FluMist express the HA and NA of wild- type viruses that are related to strains expected to circulate during the 2025-2026 influenza season. The viruses (A/H1N1, A/H3N2 and the B strain) have been recommended by the United States Public Health Service (USPHS) for inclusion in the annual trivalent influenza vaccine formulation.</paragraph> <paragraph>Specific pathogen-free (SPF) eggs are inoculated with each of the reassortant strains and incubated to allow vaccine virus replication. The allantoic fluid of these eggs is harvested, pooled, and then clarified by filtration. The virus is concentrated by ultracentrifugation and diluted with stabilizing buffer to obtain the final sucrose and potassium phosphate concentrations. The viral harvests are then sterile filtered to produce the monovalent bulks. Each lot is tested for <content styleCode="italics">ca</content>, <content styleCode="italics">ts</content>, and <content styleCode="italics">att</content> phenotypes and is also tested extensively by <content styleCode="italics">in vitro</content> and <content styleCode="italics">in vivo</content> methods to detect adventitious agents. Monovalent bulks from the three strains are subsequently blended and diluted as required to attain the desired potency with stabilizing buffers to produce the trivalent bulk vaccine. The bulk vaccine is then filled directly into individual sprayers for nasal administration.</paragraph> <paragraph>Each pre-filled refrigerated FluMist sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 10<sup>6.5-7.5 </sup>FFU (fluorescent focus units) of live attenuated influenza virus reassortants of each of the three strains: A/Norway/31694/2022 (H1N1) (an A/Victoria/4897/2022 (H1N1)pdm09 - like virus), A/Perth/722/2024 (H3N2) (an A/Croatia/10136RV/2023 (H3N2) - like virus), and B/Austria/1359417/2021 (B/Victoria lineage) (a B/Austria/1359417/2021 (B/Victoria lineage) - like virus). Each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate, 2.00 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, 13.68 mg/dose sucrose, 2.26 mg/dose dibasic potassium phosphate, and 0.96 mg/dose monobasic potassium phosphate. Each dose contains residual amounts of ovalbumin (<0.024 mcg/dose), and may also contain residual amounts of gentamicin sulfate (<0.015 mcg/mL), and ethylenediaminetetraacetic acid (EDTA) (< 2.3 mcg/dose). FluMist contains no preservatives.</paragraph> <paragraph>The tip attached to the sprayer is equipped with a nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx. FluMist is a colorless to pale yellow suspension and is clear to slightly cloudy.</paragraph> </text> <effectiveTime value="20250701"/> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_25f5c3b2-7633-4236-8949-0c4cd88e4f28"> <id root="2fcab8a3-69b6-4f08-9005-35e8c9b42134"/> <code code="34090-1" codeSystem="2.16.840.1.113883.6.1" displayName="CLINICAL PHARMACOLOGY SECTION"/> <title>12 CLINICAL PHARMACOLOGY</title> <effectiveTime value="20250701"/> <component> <section ID="ID_8b3ebcaf-bf99-4d03-a806-0c49ee30dc2a"> <id root="879e0747-16b3-4903-85ec-42e16221bf6e"/> <code code="43679-0" codeSystem="2.16.840.1.113883.6.1" displayName="MECHANISM OF ACTION SECTION"/> <title>12.1 Mechanism of Action</title> <text> <paragraph>Immune mechanisms conferring protection against influenza following receipt of FluMist vaccine are not fully understood; serum antibodies, mucosal antibodies, and influenza-specific T cells may play a role.</paragraph> <paragraph>FluMist contains live attenuated influenza viruses that must infect and replicate in cells lining the nasopharynx of the recipient to induce immunity. Vaccine viruses capable of infection and replication can be cultured from nasal secretions obtained from vaccine recipients (shedding) <content styleCode="italics">[see </content> <content styleCode="italics"> <linkHtml href="#_12_2_Pharmacodynamics">Clinical Pharmacology (12.2)</linkHtml> </content> <content styleCode="italics">].</content> </paragraph> </text> <effectiveTime value="20250701"/> </section> </component> <component> <section ID="_12_2_Pharmacodynamics"> <id root="836251b9-3f16-44c3-86b5-cad090684d98"/> <code code="43681-6" codeSystem="2.16.840.1.113883.6.1" displayName="PHARMACODYNAMICS SECTION"/> <title>12.2 Pharmacodynamics</title> <text> <paragraph> <content styleCode="bold"> <content styleCode="italics"> <content styleCode="underline">Shedding Studies</content> </content> </content> </paragraph> <paragraph>Shedding of vaccine viruses within 28 days of vaccination with FluMist was evaluated in (1) multi-center Study MI‑CP129 which enrolled healthy individuals 6 through 59 months of age (N = 200); and (2) multi-center Study FM026 which enrolled healthy individuals 5 through 49 years of age (N = 344). In each study, nasal secretions were obtained daily for the first 7 days and every other day through either Day 25 and on Day 28 or through Day 28. In Study MI‑CP129, individuals with a positive shedding sample at Day 25 or Day 28 were to have additional shedding samples collected every 7 days until culture negative on 2 consecutive samples. Results of these studies are presented in Table 3.</paragraph> <table ID="table5" styleCode="Noautorules" width="100%"> <caption>Table 3: Characterization of Shedding with FluMist in Specified Age Groups by Frequency, Amount, and Duration (Study MI-CP129<footnote ID="_Ref497474361">NCT00344305; see <linkHtml href="https://www.clinicaltrials.gov/">www.clinicaltrials.gov</linkHtml>.</footnote> and Study FM026<footnote ID="_Ref497474524">NCT00192140; see <linkHtml href="https://www.clinicaltrials.gov/">www.clinicaltrials.gov</linkHtml>.</footnote>)</caption> <col width="16%"/> <col width="16%"/> <col width="17%"/> <col width="19%"/> <col width="17%"/> <col width="16%"/> <tbody> <tr> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Age</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Number of Subjects</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">% Shedding</content> <footnote ID="_Ref497474532">Proportion of subjects with detectable virus at any time point during the 28 days.</footnote> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Peak Titer</content> <br/> <content styleCode="bold">(TCID<sub>50</sub>/mL)</content> <footnote ID="_Ref497474540">Peak titer at any time point during the 28 days among samples positive for a single vaccine virus.</footnote> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">%</content> <br/> <content styleCode="bold">Shedding After Day 11</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Day of Last Positive Culture</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>6-23 months<footnote ID="_Ref497474549">FluMist is not approved for use in children younger than 24 months of age <content styleCode="italics">[see <linkHtml href="#_6_1_Clinical_Trials">Adverse Reactions (6.1)</linkHtml>].</content> </footnote> <br/>24-59 months<br/>5-8 years<br/>9-17 years<br/>18-49 years</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> 99<br/>100<br/>102<br/>126<br/>115</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>89<br/>69<br/>50<br/>29<br/>20</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <<content styleCode="bold"> </content>5 log<sub>10</sub> <br/><<content styleCode="bold"> </content>5 log<sub>10</sub> <br/><<content styleCode="bold"> </content>5 log<sub>10</sub> <br/><<content styleCode="bold"> </content>4 log<sub>10</sub> <br/><<content styleCode="bold"> </content>3 log<sub>10</sub> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>7.0<br/>1.0<br/>2.9<br/>1.6<br/>0.9</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> Day 23<footnote ID="_Ref497474560">A single subject who shed previously on Days 1-3; TCID<sub>50</sub>/mL was less than 1.5 log<sub>10 </sub>on Day 23.</footnote> <br/> Day 25<footnote ID="_Ref497474568">A single subject who did not shed previously; TCID<sub>50</sub>/mL was less than 1.5 log<sub>10</sub>.</footnote> <br/> Day 23<footnote ID="_Ref497474576">A single subject who did not shed previously; TCID<sub>50</sub>/mL was less than 1.0 log<sub>10</sub>.</footnote> <br/> Day 28<footnoteRef IDREF="_Ref497474576"/> <br/> Day 17<footnoteRef IDREF="_Ref497474576"/> </paragraph> </td> </tr> </tbody> </table> <paragraph>The highest proportion of subjects in each group shed one or more vaccine strains on Days 2-3 post vaccination. After Day 11 among individuals 2 through 49 years of age (n = 443), virus titers did not exceed 1.5 log<sub>10</sub> TCID<sub>50</sub>/mL.</paragraph> <paragraph> <content styleCode="bold"> <content styleCode="italics"> <content styleCode="underline">Studies in Immunocompromised Individuals</content> </content> </content> </paragraph> <paragraph>Safety and shedding of vaccine virus following FluMist administration were evaluated in 28 HIV‑infected adults [median CD4 cell count of 541 cells/mm<sup>3</sup>] and 27 HIV-negative adults 18 through 58 years of age. No serious adverse events were reported during the one-month follow-up period. Vaccine strain (type B) virus was detected in 1 of 28 HIV-infected subjects on Day 5 only, and in none of the HIV-negative FluMist recipients.</paragraph> <paragraph>Safety and shedding of vaccine virus following FluMist administration were also evaluated in children in a randomized (1:1), cross-over, double-blind, AF-SPG placebo-controlled trial in 24 HIV-infected children [median CD4 cell count of 1013 cells/mm<sup>3</sup>] and 25 HIV-negative children 1 through 7 years of age, and in a randomized (1:1), open-label, inactivated influenza vaccine-controlled trial in 243 HIV-infected children and adolescents 5 through 17 years of age receiving stable anti-retroviral therapy. Frequency and duration of vaccine virus shedding in HIV-infected individuals were comparable to that seen in healthy individuals. No adverse effects on HIV viral load or CD4 counts were identified following FluMist administration. In the 5 through 17 year old age group, one inactivated influenza vaccine recipient and one FluMist recipient experienced pneumonia within 28 days of vaccination (days 17 and 13, respectively). The effectiveness of FluMist in preventing influenza illness in HIV-infected individuals has not been evaluated.</paragraph> <paragraph>Twenty mild to moderately immunocompromised children and adolescents 5 through 17 years of age (receiving chemotherapy and/or radiation therapy or who had received chemotherapy in the 12 weeks prior to enrollment) were randomized 1:1 to receive FluMist or AF-SPG placebo. Frequency and duration of vaccine virus shedding in these immunocompromised children and adolescents were comparable to that seen in healthy children and adolescents. The effectiveness of FluMist in preventing influenza illness in immunocompromised individuals has not been evaluated.</paragraph> <paragraph> <content styleCode="bold"> <content styleCode="italics"> <content styleCode="underline">Transmission Study</content> </content> </content> </paragraph> <paragraph>A prospective, randomized, double-blind, placebo-controlled trial was performed in a daycare setting in children younger than 3 years of age to assess the transmission of vaccine viruses from a vaccinated individual to a non-vaccinated individual. A total of 197 children 8 through 36 months of age were randomized to receive one dose of FluMist (N = 98) or AF-SPG placebo (N = 99). Virus shedding was evaluated for 21 days by culture of nasal swab specimens. Wild-type A (A/H3N2) influenza virus was documented to have circulated in the community and in the study population during the trial, whereas Type A (A/H1N1) and Type B strains did not.</paragraph> <paragraph>At least one vaccine strain was isolated from 80% of FluMist recipients; strains were recovered from 1-21 days post vaccination (mean duration of 7.6 days ± 3.4 days). The <content styleCode="italics">ca</content> and <content styleCode="italics">ts</content> phenotypes were preserved in 135 tested of 250 strains isolated at the local laboratory. Ten influenza isolates (9 influenza A, 1 influenza B) were cultured from a total of seven placebo subjects. One placebo subject had mild symptomatic Type B virus infection confirmed as a transmitted vaccine virus by a FluMist recipient in the same playgroup. This Type B isolate retained the <content styleCode="italics">ca</content>, <content styleCode="italics">ts</content>, and <content styleCode="italics">att</content> phenotypes of the vaccine strain and had the same genetic sequence when compared to a Type B virus cultured from a vaccine recipient within the same playgroup. Four of the influenza Type A isolates were confirmed as wild-type A/Panama (H3N2). The remaining isolates could not be further characterized.</paragraph> <paragraph>Assuming a single transmission event (isolation of the Type B vaccine strain), the probability of a young child acquiring vaccine virus following close contact with a single FluMist vaccinee in this daycare setting was 0.58% (95% CI: 0, 1.7) based on the Reed-Frost model. With documented transmission of one Type B in one placebo subject and possible transmission of Type A viruses in four placebo subjects, the probability of acquiring a transmitted vaccine virus was estimated to be 2.4% (95% CI: 0.13, 4.6) using the Reed-Frost model.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_9c2f945a-c2ef-4584-b11b-429fd38d5319"> <id root="91a5a4b5-0e23-4246-8e6b-610bef40e2c0"/> <code code="43680-8" codeSystem="2.16.840.1.113883.6.1" displayName="NONCLINICAL TOXICOLOGY SECTION"/> <title>13 NONCLINICAL TOXICOLOGY</title> <effectiveTime value="20250701"/> <component> <section ID="ID_fe491520-7d67-445c-b850-4ce6f926f778"> <id root="8443f025-b2a8-455d-b375-b4ecadcf29a2"/> <code code="34083-6" codeSystem="2.16.840.1.113883.6.1" displayName="CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION"/> <title>13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility</title> <text> <paragraph>FluMist has not been evaluated for its carcinogenic or mutagenic potential.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="_14_CLINICAL_STUDIES"> <id root="7f94614e-2b2a-4164-bdcf-a30f242d2003"/> <code code="34092-7" codeSystem="2.16.840.1.113883.6.1" displayName="CLINICAL STUDIES SECTION"/> <title>14 CLINICAL STUDIES</title> <effectiveTime value="20250701"/> <component> <section ID="_14_1_Efficacy_Studies"> <id root="a65dada5-3d9b-49e5-9c9f-81f592c26b31"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>14.1 Efficacy Studies of FluMist in Children</title> <text> <paragraph>A multi-national, randomized, double-blind, active-controlled trial (MI-CP111) was performed to assess the efficacy of FluMist compared to an intramuscularly administered, inactivated Influenza Virus Vaccine manufactured by Sanofi Pasteur Inc. (active control) in children 6 months to less than 5 years of age during the 2004-2005 influenza season. A total number of 3916 children without severe asthma, without use of bronchodilator or steroids, and without wheezing within the prior 6 weeks were randomized to FluMist and 3936 were randomized to active control. Children who previously received any influenza vaccine received a single dose of study vaccine, while those who never previously received an influenza vaccination (or had an unknown history of influenza vaccination) received two doses. Participants were then followed through the influenza season to identify illness caused by influenza virus. As the primary endpoint, culture-confirmed modified CDC-ILI (CDC-defined influenza-like illness) was defined as a positive culture for a wild-type influenza virus associated within ±7 days of modified CDC-ILI. Modified CDC-ILI was defined as fever (temperature ≥100°F oral or equivalent) with cough, sore throat, or runny nose/nasal congestion on the same or consecutive days.</paragraph> <paragraph>In the primary efficacy analysis, FluMist demonstrated a 44.5% (95% CI: 22.4, 60.6) reduction in influenza rate compared to active control as measured by culture-confirmed modified CDC-ILI caused by wild-type strains antigenically similar to those contained in the vaccine. See Table 4 for a description of the results by strain and antigenic similarity.</paragraph> <table ID="table6" width="100%"> <caption>Table 4: Comparative Efficacy Against Culture-Confirmed Modified CDC-ILI<footnote ID="_Ref497474721">Modified CDC-ILI was defined as fever (temperature ≥ 100°F oral or equivalent) plus cough, sore throat, or runny nose/nasal congestion on the same or consecutive days.</footnote> Caused by Wild-Type Strains (Study MI-CP111)<footnote ID="_Ref497474859">In children 6 months through 5 years of age.</footnote> <footnote ID="_Ref497474865">NCT00128167; see <linkHtml href="https://www.clinicaltrials.gov/">www.clinicaltrials.gov</linkHtml>.</footnote> </caption> <col width="17%"/> <col width="8%"/> <col width="9%"/> <col width="11%"/> <col width="8%"/> <col width="10%"/> <col width="12%"/> <col width="12%"/> <col width="14%"/> <tbody> <tr> <td rowspan="2" styleCode="Botrule Toprule " valign="top"> <paragraph> </paragraph> <paragraph> </paragraph> </td> <td align="center" colspan="3" styleCode="Rrule Botrule Toprule " valign="top"> <paragraph> <content styleCode="bold">FluMist</content> </paragraph> </td> <td align="center" colspan="3" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Active Control</content> <footnote ID="_Ref497474873">Inactivated Influenza Virus Vaccine manufactured by Sanofi Pasteur Inc., administered intramuscularly.</footnote> </paragraph> </td> <td align="center" rowspan="2" styleCode="Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">%</content> <br/> <content styleCode="bold">Reduction </content> <br/> <content styleCode="bold">in Rate for FluMist</content> <footnote ID="_Ref497474899">Reduction in rate was adjusted for country, age, prior influenza vaccination status, and wheezing history status.</footnote> </paragraph> </td> <td align="center" rowspan="2" styleCode="Botrule Toprule " valign="top"> <paragraph> </paragraph> <paragraph> <content styleCode="bold">95% CI</content> </paragraph> </td> </tr> <tr> <td align="center" styleCode="Toprule Botrule " valign="bottom"> <paragraph> <content styleCode="bold">N</content> </paragraph> </td> <td align="center" styleCode="Toprule Botrule " valign="bottom"> <paragraph> <content styleCode="bold"># of </content> <br/> <content styleCode="bold">Cases</content> </paragraph> </td> <td align="center" styleCode="Rrule Toprule Botrule " valign="bottom"> <paragraph> <content styleCode="bold">Rate</content> <br/> <content styleCode="bold">(cases/N)</content> </paragraph> </td> <td align="center" styleCode="Lrule Toprule Botrule " valign="bottom"> <paragraph> <content styleCode="bold">N</content> </paragraph> </td> <td align="center" styleCode="Toprule Botrule " valign="bottom"> <paragraph> <content styleCode="bold"># of </content> <br/> <content styleCode="bold">Cases</content> </paragraph> </td> <td align="center" styleCode="Rrule Toprule Botrule " valign="bottom"> <paragraph> <content styleCode="bold">Rate</content> <br/> <content styleCode="bold">(cases/N)</content> </paragraph> </td> </tr> <tr> <td colspan="2" valign="top"> <paragraph> Matched Strains</paragraph> </td> <td colspan="2" styleCode="Rrule Toprule " valign="top"/> <td colspan="3" styleCode="Rrule Lrule Toprule " valign="top"/> <td colspan="2" styleCode="Lrule Toprule " valign="top"/> </tr> <tr> <td valign="top"> <paragraph> All strains</paragraph> </td> <td align="center" valign="top"> <paragraph> 3916</paragraph> </td> <td align="center" valign="top"> <paragraph> 53</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph> 1.4%</paragraph> </td> <td align="center" styleCode="Lrule " valign="top"> <paragraph> 3936</paragraph> </td> <td align="center" valign="top"> <paragraph> 93</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph> 2.4%</paragraph> </td> <td align="center" styleCode="Lrule " valign="top"> <paragraph> 44.5%</paragraph> </td> <td align="center" valign="top"> <paragraph> 22.4, 60.6</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> A/H1N1</paragraph> </td> <td align="center" valign="top"> <paragraph> 3916</paragraph> </td> <td align="center" valign="top"> <paragraph> 3</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph> 0.1%</paragraph> </td> <td align="center" styleCode="Lrule " valign="top"> <paragraph> 3936</paragraph> </td> <td align="center" valign="top"> <paragraph> 27</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph> 0.7%</paragraph> </td> <td align="center" styleCode="Lrule " valign="top"> <paragraph> 89.2%</paragraph> </td> <td align="center" valign="top"> <paragraph> 67.7, 97.4</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> A/H3N2</paragraph> </td> <td align="center" valign="top"> <paragraph> 3916</paragraph> </td> <td align="center" valign="top"> <paragraph> 0</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph> 0.0%</paragraph> </td> <td align="center" styleCode="Lrule " valign="top"> <paragraph> 3936</paragraph> </td> <td align="center" valign="top"> <paragraph> 0</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph> 0.0%</paragraph> </td> <td align="center" styleCode="Lrule " valign="top"> <paragraph> --</paragraph> </td> <td align="center" valign="top"> <paragraph> --</paragraph> </td> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph> B</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph> 3916</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph> 50</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> 1.3%</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph> 3936</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph> 67</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> 1.7%</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph> 27.3%</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph> -4.8, 49.9</paragraph> </td> </tr> <tr> <td colspan="2" styleCode="Toprule " valign="top"> <paragraph>Mismatched Strains</paragraph> </td> <td colspan="2" styleCode="Rrule Toprule " valign="top"/> <td styleCode="Toprule " valign="top"/> <td colspan="2" styleCode="Rrule Toprule " valign="top"/> <td colspan="2" styleCode="Toprule " valign="top"/> </tr> <tr> <td valign="top"> <paragraph> All strains</paragraph> </td> <td align="center" valign="top"> <paragraph> 3916</paragraph> </td> <td align="center" valign="top"> <paragraph> 102</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph> 2.6%</paragraph> </td> <td align="center" styleCode="Lrule " valign="top"> <paragraph> 3936</paragraph> </td> <td align="center" valign="top"> <paragraph> 245</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph> 6.2%</paragraph> </td> <td align="center" styleCode="Lrule " valign="top"> <paragraph> 58.2%</paragraph> </td> <td align="center" valign="top"> <paragraph> 47.4, 67.0</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> A/H1N1</paragraph> </td> <td align="center" valign="top"> <paragraph> 3916</paragraph> </td> <td align="center" valign="top"> <paragraph> 0</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph> 0.0%</paragraph> </td> <td align="center" styleCode="Lrule " valign="top"> <paragraph> 3936</paragraph> </td> <td align="center" valign="top"> <paragraph> 0</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph> 0.0%</paragraph> </td> <td align="center" styleCode="Lrule " valign="top"> <paragraph> --</paragraph> </td> <td align="center" valign="top"> <paragraph> --</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> A/H3N2</paragraph> </td> <td align="center" valign="top"> <paragraph> 3916</paragraph> </td> <td align="center" valign="top"> <paragraph> 37</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph> 0.9%</paragraph> </td> <td align="center" styleCode="Lrule " valign="top"> <paragraph> 3936</paragraph> </td> <td align="center" valign="top"> <paragraph> 178</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph> 4.5%</paragraph> </td> <td align="center" styleCode="Lrule " valign="top"> <paragraph> 79.2%</paragraph> </td> <td align="center" valign="top"> <paragraph> 70.6, 85.7</paragraph> </td> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph> B</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph> 3916</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph> 66</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> 1.7%</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph> 3936</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph> 71</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> 1.8%</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph> 6.3%</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph> -31.6, 33.3</paragraph> </td> </tr> <tr> <td styleCode="Toprule " valign="top"> <paragraph>Regardless of Match</paragraph> </td> <td colspan="3" styleCode="Rrule Toprule " valign="top"> <paragraph> </paragraph> </td> <td colspan="3" styleCode="Rrule Lrule Toprule " valign="top"/> <td styleCode="Lrule Toprule " valign="top"/> <td styleCode="Toprule " valign="top"/> </tr> <tr> <td valign="top"> <paragraph> All strains</paragraph> </td> <td align="center" valign="top"> <paragraph> 3916</paragraph> </td> <td align="center" valign="top"> <paragraph> 153</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph> 3.9%</paragraph> </td> <td align="center" styleCode="Lrule " valign="top"> <paragraph> 3936</paragraph> </td> <td align="center" valign="top"> <paragraph> 338</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph> 8.6%</paragraph> </td> <td align="center" styleCode="Lrule " valign="top"> <paragraph> 54.9%</paragraph> </td> <td align="center" valign="top"> <paragraph> 45.4, 62.9</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> A/H1N1</paragraph> </td> <td align="center" valign="top"> <paragraph> 3916</paragraph> </td> <td align="center" valign="top"> <paragraph> 3</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph> 0.1%</paragraph> </td> <td align="center" styleCode="Lrule " valign="top"> <paragraph> 3936</paragraph> </td> <td align="center" valign="top"> <paragraph> 27</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph> 0.7%</paragraph> </td> <td align="center" styleCode="Lrule " valign="top"> <paragraph> 89.2%</paragraph> </td> <td align="center" valign="top"> <paragraph> 67.7, 97.4</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> A/H3N2</paragraph> </td> <td align="center" valign="top"> <paragraph> 3916</paragraph> </td> <td align="center" valign="top"> <paragraph> 37</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph> 0.9%</paragraph> </td> <td align="center" styleCode="Lrule " valign="top"> <paragraph> 3936</paragraph> </td> <td align="center" valign="top"> <paragraph> 178</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph> 4.5%</paragraph> </td> <td align="center" styleCode="Lrule " valign="top"> <paragraph> 79.2%</paragraph> </td> <td align="center" valign="top"> <paragraph> 70.6, 85.7</paragraph> </td> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph> B</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph> 3916</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph> 115</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> 2.9%</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph> 3936</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph> 136</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> 3.5%</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph> 16.1%</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph> -7.7, 34.7</paragraph> </td> </tr> <tr> <td align="justify" colspan="9" valign="top"> <paragraph> <content styleCode="italics">ATP Population.</content> </paragraph> </td> </tr> </tbody> </table> <paragraph>A randomized, double-blind, saline placebo-controlled trial (D153-P501) was performed to evaluate the efficacy of FluMist in children 12 through 35 months of age without high-risk medical conditions against culture-confirmed influenza illness. This study was performed in Asia over two successive seasons (2000-2001 and 2001-2002). The primary endpoint of the trial was the prevention of culture-confirmed influenza illness due to antigenically matched wild-type influenza. Respiratory illness that prompted an influenza culture was defined as at least one of the following: fever (≥100.4°F rectal or ≥99.5°F axillary), wheezing, shortness of breath, pulmonary congestion, pneumonia, or otitis media; or two of the following: runny nose/nasal congestion, sore throat, cough, muscle aches, chills, headache, irritability, decreased activity, or vomiting.<content styleCode="bold"> </content>A total of 3174 children were randomized 3:2 (vaccine:placebo) to receive 2 doses of study vaccine or placebo at least 28 days<content styleCode="bold"> </content>apart in Year 1. See Table 5 for a description of the results.</paragraph> <paragraph>During the second year of Study D153-P501, for children who received two doses in Year 1 and one dose in Year 2, FluMist demonstrated 84.3% (95% CI: 70.1, 92.4) efficacy against culture-confirmed influenza illness due to antigenically matched wild-type influenza.</paragraph> <paragraph>Study AV006 was a second multi-center, randomized, double-blind, AF-SPG placebo-controlled trial performed in U.S. children without high-risk medical conditions to evaluate the efficacy of FluMist against culture-confirmed influenza over two successive seasons (1996-1997 and 1997-1998). The primary endpoint of the trial was the prevention of culture-confirmed influenza illness due to antigenically matched wild-type influenza in children who received two doses of vaccine in the first year and a single revaccination dose in the second year.<content styleCode="bold"> </content>Respiratory illness that prompted an influenza culture was defined as at least one of the following: fever (≥101°F rectal or oral; or ≥100.4°F axillary), wheezing, shortness of breath, pulmonary congestion, pneumonia, or otitis media; or two of the following: runny nose/nasal congestion, sore throat, cough, muscle aches, chills, headache, irritability, decreased activity, or vomiting. During the first year of the study, 1602 children 15 through 71 months of age were randomized 2:1 (vaccine:placebo). See Table 5 for a description of the results.</paragraph> <table ID="table7" styleCode="Noautorules" width="100%"> <caption>Table 5: Efficacy<footnote ID="_Ref497475033">D153-P501 and AV006 data are for subjects who received two doses of study vaccine.</footnote> of FluMist vs. Placebo Against Culture-Confirmed Influenza Illness Due to Antigenically Matched Wild-Type Strains (Studies D153-P501<footnote ID="_Ref497475555">In children 12 through 35 months of age.</footnote> & AV006<footnote ID="_Ref497475563">In children 15 through 71 months of age.</footnote>, Year 1)</caption> <col width="12%"/> <col width="12%"/> <col width="12%"/> <col width="17%"/> <col width="12%"/> <col width="18%"/> <col width="17%"/> <tbody> <tr> <td styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> </paragraph> </td> <td align="center" colspan="3" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">D153-P501</content> <footnote ID="_Ref497475621">NCT00192244; see <linkHtml href="https://www.clinicaltrials.gov/">www.clinicaltrials.gov</linkHtml>.</footnote> </paragraph> </td> <td align="center" colspan="3" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">AV006</content> <footnote ID="_Ref497475635">NCT00192179; see <linkHtml href="https://www.clinicaltrials.gov/">www.clinicaltrials.gov</linkHtml>.</footnote> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> <content styleCode="bold">FluMist</content> <br/> <content styleCode="bold">n</content> <footnote ID="_Ref497475643">Number and percent of subjects in per-protocol efficacy analysis population with culture-confirmed influenza illness.</footnote> <content styleCode="bold">(%)</content> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> <content styleCode="bold">Placebo</content> <br/> <content styleCode="bold">n</content> <footnoteRef IDREF="_Ref497475643"/> <content styleCode="bold">(%)</content> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> <content styleCode="bold">% Efficacy</content> <br/> <content styleCode="bold">(95% CI)</content> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> <content styleCode="bold">FluMist</content> <br/> <content styleCode="bold">n</content> <footnoteRef IDREF="_Ref497475643"/> <content styleCode="bold">(%)</content> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> <content styleCode="bold">Placebo</content> <br/> <content styleCode="bold">n</content> <footnoteRef IDREF="_Ref497475643"/> <content styleCode="bold">(%)</content> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> <content styleCode="bold">% Efficacy</content> <br/> <content styleCode="bold">(95% CI)</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> <content styleCode="bold">N</content> <footnote ID="_Ref497475687">Number of subjects in per-protocol efficacy analysis population of each treatment group of each study for the “any strain” analysis.</footnote> <content styleCode="bold"> = 1653</content> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> <content styleCode="bold">N</content> <footnoteRef IDREF="_Ref497475687"/> <content styleCode="bold"> = 1111</content> </paragraph> </td> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> <content styleCode="bold">N</content> <footnoteRef IDREF="_Ref497475687"/> <content styleCode="bold"> = 849</content> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>N<footnoteRef IDREF="_Ref497475687"/> = 410</paragraph> </td> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Any strain</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 56 (3.4%) </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>139 (12.5%)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 72.9%<footnote ID="_Ref497475724">For D153-P501, influenza circulated through 12 months following vaccination.</footnote> <br/>(62.8, 80.5)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 10 (1%)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 73 (18%)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 93.4%<br/>(87.5, 96.5)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> A/H1N1</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 23 (1.4%)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 81 (7.3%)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 80.9%<br/>(69.4, 88.5)<footnote ID="_Ref497475732">Estimate includes A/H1N1 and A/H1N2 strains. Both were considered antigenically similar to the vaccine.</footnote> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> --</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> A/H3N2</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 4 (0.2%)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 27 (2.4%)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 90.0%<br/>(71.4, 97.5)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 4 (0.5%)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 48 (12%)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> 96.0%<br/>(89.4, 98.5)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> B</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> 29 (1.8%)</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> 35 (3.2%)</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> 44.3%<br/>(6.2, 67.2)</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> 6 (0.7%)</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> 31 (7%)</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> 90.5%<br/>(78.0, 95.9)</paragraph> </td> </tr> </tbody> </table> <paragraph>During the second year of Study AV006, children remained in the same treatment group as in Year 1 and received a single dose of FluMist or placebo. During the second year, the primary circulating strain was the A/Sydney/05/97 H3N2 strain, which was antigenically dissimilar from the H3N2 strain represented in the vaccine, A/Wuhan/359/95; FluMist demonstrated 87.0% (95% CI: 77.0, 92.6) efficacy against culture-confirmed influenza illness.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> <component> <section ID="_14_3_Effectiveness_Study"> <id root="69e13f0d-ac5d-4e32-ba5d-872ae23ae023"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>14.2 Effectiveness Study of FluMist in Adults</title> <text> <paragraph>AV009 was a U.S. multi-center, randomized, double-blind, AF-SPG placebo-controlled trial to evaluate effectiveness of FluMist in adults 18 through 64 years of age without high-risk medical conditions over the 1997-1998 influenza season. Participants were randomized 2:1 (vaccine:placebo). Cultures for influenza virus were not obtained from subjects in the trial, thus efficacy against culture-confirmed influenza was not assessed. The A/Wuhan/359/95 (H3N2) strain, which was contained in FluMist, was antigenically distinct from the predominant circulating strain of influenza virus during the trial period, A/Sydney/05/97 (H3N2). Type A/Wuhan (H3N2) and Type B strains also circulated in the U.S. during the study period. The primary endpoint of the trial was the reduction in the proportion of participants with one or more episodes of any febrile illness, and prospective secondary endpoints were severe febrile illness and febrile upper respiratory illness. Effectiveness for any of the three endpoints was not demonstrated in a subgroup of adults 50 through 64 years of age. Primary and secondary effectiveness endpoints from the age group 18 through 49 years are presented in Table 6. Effectiveness was not demonstrated for the primary endpoint in adults 18 through 49 years of age.</paragraph> <table ID="table8" styleCode="Noautorules" width="100%"> <caption>Table 6: Effectiveness of FluMist to Prevent Febrile Illness in Adults 18 through 49 Years of Age During the 7-Week Site-Specific Outbreak Period (Study AV009)</caption> <col width="37%"/> <col width="18%"/> <col width="17%"/> <col width="13%"/> <col width="16%"/> <tbody> <tr> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Endpoint</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">FluMist</content> <br/> <content styleCode="bold">N = 2411<footnote ID="_Ref497475819">Number of evaluable subjects (92.7% and 93.0% of FluMist and placebo recipients, respectively).</footnote> <sup> </sup> <br/>n (%)</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Placebo</content> <br/> <content styleCode="bold">N = 1226<footnoteRef IDREF="_Ref497475819"/> <br/>n (%)</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Percent</content> <br/> <content styleCode="bold">Reduction</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">(95% CI)</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Participants with one or more </content> <br/> <content styleCode="bold">events of:</content> <footnote ID="_Ref497475925">The predominantly circulating virus during the trial period was A/Sydney/05/97 (H3N2), an antigenic variant not included in the vaccine.</footnote> <br/>Primary Endpoint:<br/>Any febrile illness<br/>Secondary Endpoints:<br/>Severe febrile illness<br/>Febrile upper respiratory illness</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <br/> <br/> <br/>331 (13.73)<br/> <br/>250 (10.37)<br/>213 (8.83)</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <br/> <br/> <br/>189 (15.42)<br/> <br/>158 (12.89)<br/>142 (11.58)</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <br/> <br/> <br/> <content styleCode="bold">10.9</content> <br/> <br/> <content styleCode="bold">19.5</content> <br/> <content styleCode="bold">23.7</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <br/> <br/> <br/>(-5.1, 24.4)<br/> <br/>(3.0, 33.2)<br/>(6.7, 37.5)</paragraph> </td> </tr> </tbody> </table> <paragraph>Effectiveness was shown in a post-hoc analysis using an endpoint of CDC-ILI in the age group 18 through 49 years of age.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> <component> <section ID="_14_5_Concomitantly_Administered"> <id root="e5763ef2-01f5-4047-b1d5-bb54d99e096c"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>14.3 Concomitantly Administered Live Virus Vaccines</title> <text> <paragraph>In Study AV018, concomitant administration of FluMist, MMR (manufactured by Merck & Co., Inc.) and Varicella Virus Vaccine Live (manufactured by Merck & Co., Inc.) was studied in 1245 subjects 12 through 15 months of age. Subjects were randomized in a 1:1:1 ratio to MMR, Varicella vaccine and AF-SPG placebo (group 1); MMR, Varicella vaccine and FluMist (group 2); or FluMist alone (group 3). Immune responses to MMR and Varicella vaccines were evaluated 6 weeks post-vaccination while the immune responses to FluMist were evaluated 4 weeks after the second dose. No evidence of interference with immune response to measles, mumps, rubella, varicella and FluMist vaccines was observed.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_a4fdd1b6-3848-484c-a298-12c101e81987"> <id root="48b56b44-a31e-4320-9c32-5ffa1a43ee7a"/> <code code="34093-5" codeSystem="2.16.840.1.113883.6.1" displayName="REFERENCES SECTION"/> <title>15 REFERENCES</title> <text> <list listType="ordered"> <item> <caption>1.</caption>Lasky T, Terracciano GJ, Magder L, et al. The Guillain-Barré syndrome and the 1992 – 1993 and 1993 – 1994 influenza vaccines. N Engl J Med 1998;339(25):1797-802.</item> </list> </text> <effectiveTime value="20250701"/> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_585d212c-da46-421e-83d9-d9a7a398f120"> <id root="585d212c-da46-421e-83d9-d9a7a398f120"/> <code code="34069-5" codeSystem="2.16.840.1.113883.6.1" displayName="HOW SUPPLIED SECTION"/> <title>16 HOW SUPPLIED/STORAGE AND HANDLING </title> <effectiveTime value="20250701"/> <component> <section ID="ID_415d7bab-c6c8-4346-9708-cfd8742758cb"> <id root="415d7bab-c6c8-4346-9708-cfd8742758cb"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>16.1 How Supplied </title> <text> <paragraph>FluMist is supplied in a single-dose (0.2 mL) intranasal sprayer. The single-use intranasal sprayer is not made with natural rubber latex.</paragraph> <paragraph>Single intranasal sprayer: NDC 66019-112-00</paragraph> <paragraph>Carton containing 1 intranasal sprayer: NDC 66019-112-51</paragraph> <paragraph>Carton containing 10 intranasal sprayers: NDC 66019-112-10</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> <component> <section ID="ID_92499251-40be-49f0-82ea-82048b1dd082"> <id root="92499251-40be-49f0-82ea-82048b1dd082"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>16.2 Storage and Handling </title> <text> <paragraph> <content styleCode="bold">FLUMIST SHOULD BE STORED IN A REFRIGERATOR BETWEEN 2-8°C (35-46°F) UPON RECEIPT. THE PRODUCT MUST NOT BE USED AFTER THE EXPIRATION DATE ON THE SPRAYER LABEL.</content> </paragraph> <paragraph> <content styleCode="bold">DO NOT FREEZE.</content> </paragraph> <paragraph>Keep FluMist sprayer in outer carton in order to protect from light.</paragraph> <paragraph>A single temperature excursion up to 25°C (77°F) for 12 hours has been shown to have no adverse impact on the vaccine. After a temperature excursion, the vaccine should be returned immediately to the recommended storage condition (2°C – 8°C [35 – 46°F]) and used as soon as feasible. Subsequent excursions are not permitted.</paragraph> <paragraph>In a healthcare setting, when FluMist has been administered or has expired, the sprayer should be disposed of according to the standard procedures for medical waste (e.g., sharps container or biohazard container). Instruct vaccine recipients or caregivers who administer FluMist to follow the directions provided in the “Instructions for Use” for disposal of FluMist.</paragraph> </text> <effectiveTime value="20250701"/> </section> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_446dee38-2afd-4610-bcbd-bee8bed95ab3"> <id root="55b1baec-2eab-40ac-b3ad-db2add379db8"/> <code code="34076-0" codeSystem="2.16.840.1.113883.6.1" displayName="INFORMATION FOR PATIENTS SECTION"/> <title>17 PATIENT COUNSELING INFORMATION</title> <text> <paragraph>When FluMist is self-administered or administered by a caregiver, instruct the vaccine recipient or caregiver to read the “Instructions for Use.” Individuals 2 through 17 years of age should not self‑administer FluMist. </paragraph> <paragraph>Advise the vaccine recipient or caregiver to read the FDA-approved patient labeling (Information for Patients and Their Caregivers). </paragraph> <paragraph>Provide the Vaccine Information Statements (VIS) which are required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization.</paragraph> <paragraph> <content styleCode="italics"> <content styleCode="underline">Dosing in Children 2 through 8 years of age </content> </content> </paragraph> <paragraph>Inform the caregiver of the need for two doses at least 1 month apart in children 2 through 8 years of age, depending on vaccination history. </paragraph> <paragraph> <content styleCode="italics"> <content styleCode="underline">Asthma and Recurrent Wheezing </content> </content> </paragraph> <paragraph>Ask if the vaccine recipient has asthma. For children younger than 5 years of age, also ask if the vaccine recipient has recurrent wheezing since this may be an asthma equivalent in this age group. Inform the vaccine recipient or caregiver that there may be an increased risk of wheezing associated with FluMist in persons younger than 5 years of age with recurrent wheezing and persons of any age with <content styleCode="italics">asthma [see <linkHtml href="#_5_2_Asthma__Recurrent">Warnings and Precautions (5.2)</linkHtml>]</content>. </paragraph> <paragraph> <content styleCode="italics"> <content styleCode="underline">Vaccination with a Live Virus Vaccine </content> </content> </paragraph> <paragraph>Inform the vaccine recipient or caregiver that FluMist is an attenuated live virus vaccine and has the potential for transmission to immunocompromised household contacts.</paragraph> <paragraph> <content styleCode="italics"> <content styleCode="underline">Acute Allergic Reactions </content> </content> </paragraph> <paragraph>Instruct the vaccine recipient or caregiver to seek immediate medical attention if the vaccine recipient experiences any symptoms of an acute allergic reaction <content styleCode="italics">[see <linkHtml href="#ID_2a00e148-c947-4132-ab20-2c13df5e8d34">Warnings and Precautions (5.6)</linkHtml>]</content>.</paragraph> <paragraph> <content styleCode="italics"> <content styleCode="underline">Adverse Event Reporting </content> </content> </paragraph> <paragraph>Instruct the vaccine recipient or caregiver to report adverse reactions to their healthcare provider. </paragraph> <paragraph>FluMist<sup>®</sup> is a registered trademark of MedImmune, LLC.</paragraph> <renderMultiMedia ID="id-2036178745" referencedObject="ID_96dc141f-093b-4005-a1e8-524ecbb8dcc2"/> <paragraph> <content styleCode="bold">Manufactured by:</content> </paragraph> <paragraph>MedImmune, LLC</paragraph> <paragraph>Gaithersburg, MD 20878</paragraph> <paragraph>1-877-633-4411</paragraph> <paragraph>U.S. Government License No. 1799</paragraph> <paragraph>Issue Date: August 2025</paragraph> </text> <effectiveTime value="20250701"/> <component> <observationMedia ID="ID_96dc141f-093b-4005-a1e8-524ecbb8dcc2"> <text>logo</text> <value mediaType="image/jpeg"> <reference value="logo.jpg"/> </value> </observationMedia> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_86da76aa-e730-4964-a578-3aae64d79fb7"> <id root="86da76aa-e730-4964-a578-3aae64d79fb7"/> <code code="42230-3" codeSystem="2.16.840.1.113883.6.1" displayName="SPL PATIENT PACKAGE INSERT SECTION"/> <title>Patient Package Insert </title> <text> <table width="100%"> <col width="50%"/> <col width="50%"/> <tbody> <tr> <td align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Information for Patients and Their Caregivers</content> </paragraph> <paragraph> <content styleCode="bold">FluMist® (FLEW-mĭst)</content> </paragraph> <paragraph> <content styleCode="bold">(Influenza Vaccine Live, Intranasal)</content> </paragraph> </td> </tr> <tr> <td colspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Please read this Patient Information carefully before getting FluMist.</content> </paragraph> <paragraph>This is a summary of information about FluMist. It does not take the place of talking with your healthcare provider about influenza vaccination. If you have questions or would like more information, please talk with your healthcare provider.</paragraph> </td> </tr> <tr> <td colspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">What is FluMist?</content> </paragraph> <paragraph>FluMist is a vaccine that is sprayed into the nose to help protect against influenza. It can be used in children, adolescents, and adults ages 2 through 49 years. FluMist may not prevent influenza in everyone who gets vaccinated.</paragraph> </td> </tr> <tr> <td colspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Who should not get FluMist?</content> </paragraph> <paragraph>You should not get FluMist if you:</paragraph> <list listType="unordered"> <item> <caption>•</caption>have a severe allergy to eggs or to any inactive ingredient in the vaccine (see “What are the ingredients in FluMist?”)</item> <item> <caption>•</caption>have ever had a severe allergic reaction to influenza vaccinations.</item> <item> <caption>•</caption>are 2 through 17 years of age and take aspirin or medicines containing aspirin. Children or adolescents should not be given aspirin for 4 weeks after getting FluMist unless your healthcare provider tells you otherwise.</item> </list> <paragraph>Please talk to your healthcare provider if you are not sure if the items listed above apply to you or your child.</paragraph> <paragraph>Children under 2 years of age have an increased risk of wheezing (difficulty with breathing) after getting FluMist.</paragraph> </td> </tr> <tr> <td colspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Before getting FluMist, tell your healthcare provider about all your medical conditions, including if you:</content> </paragraph> <list listType="unordered"> <item> <caption>•</caption>are currently wheezing</item> <item> <caption>•</caption>have a history of wheezing and are under 5 years of age</item> <item> <caption>•</caption>have asthma</item> <item> <caption>•</caption>have had Guillain-Barré syndrome</item> <item> <caption>•</caption>have a weakened immune system or live with someone who has a severely weakened immune system</item> <item> <caption>•</caption>have problems with your heart, kidneys, or lungs</item> <item> <caption>•</caption>have diabetes</item> <item> <caption>•</caption>are pregnant or nursing</item> <item> <caption>•</caption>are taking antiviral drugs for the treatment of influenza</item> </list> <paragraph>If you or your child cannot get FluMist, you may still be able to get an influenza vaccine. Talk to your healthcare provider about this.</paragraph> </td> </tr> <tr> <td colspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">How is FluMist given?</content> </paragraph> <list listType="unordered"> <item> <caption>•</caption>FluMist is a liquid that is sprayed into the nose.</item> <item> <caption>•</caption>You can breathe normally while getting FluMist. There is no need to inhale or sniff it.</item> <item> <caption>•</caption>People 9 years of age and older need one dose of FluMist each year.</item> <item> <caption>•</caption>Children 2 through 8 years of age may need 2 doses of FluMist, depending on their history of previous influenza vaccination. Your healthcare provider will decide if your child needs a second dose.</item> </list> <paragraph>If you are giving FluMist to yourself or someone else, read the “Instructions for Use” that comes with FluMist. Individuals 2 through 17 years of age should not give themselves FluMist.</paragraph> </td> </tr> <tr> <td colspan="2" styleCode="Rrule Lrule " valign="top"> <paragraph> <content styleCode="bold">What are the possible side effects of FluMist?</content> </paragraph> <paragraph> <content styleCode="bold">There is a very small chance that FluMist could cause a severe allergic reaction</content>. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose. Seek medical attention right away if you experience:</paragraph> </td> </tr> <tr> <td styleCode="Lrule " valign="top"> <list listType="unordered"> <item> <caption>•</caption>hives (itchy, raised bumps on the skin)</item> <item> <caption>•</caption>severe flushing of the skin</item> <item> <caption>•</caption>throat tightness</item> <item> <caption>•</caption>trouble swallowing or speaking</item> <item> <caption>•</caption>trouble breathing or wheezing</item> </list> </td> <td styleCode="Rrule " valign="top"> <list listType="unordered"> <item> <caption>•</caption>swelling of the face, lips, eyes, tongue, or throat </item> <item> <caption>•</caption>chest discomfort or tightness</item> <item> <caption>•</caption>dizziness or fainting</item> <item> <caption>•</caption>severe stomach cramps or pain, vomiting or diarrhea</item> </list> </td> </tr> <tr> <td colspan="2" styleCode="Lrule " valign="top"> <paragraph> <content styleCode="bold">The most common side effects are:</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule " valign="top"> <list listType="unordered"> <item> <caption>•</caption>runny or stuffy nose</item> <item> <caption>•</caption>sore throat</item> </list> </td> <td styleCode="Rrule " valign="top"> <list listType="unordered"> <item> <caption>•</caption>fever over 100°F</item> </list> </td> </tr> <tr> <td colspan="2" styleCode="Rrule Lrule " valign="top"> <paragraph> <content styleCode="bold">Other possible side effects include:</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule " valign="top"> <list listType="unordered"> <item> <caption>•</caption>decreased appetite</item> <item> <caption>•</caption>irritability</item> <item> <caption>•</caption>tiredness</item> <item> <caption>•</caption>cough</item> </list> </td> <td styleCode="Rrule " valign="top"> <list listType="unordered"> <item> <caption>•</caption>headache</item> <item> <caption>•</caption>muscle ache</item> <item> <caption>•</caption>chills</item> </list> </td> </tr> <tr> <td colspan="2" styleCode="Rrule Lrule " valign="top"> <paragraph>These are not all the possible side effects of FluMist. For more information, talk to your healthcare provider.</paragraph> <paragraph>Call your healthcare provider for medical advice about side effects. You may report side effects to VAERS at 1-800-822-7967 or <linkHtml href="https://vaers.hhs.gov/">http://vaers.hhs.gov</linkHtml>.</paragraph> </td> </tr> <tr> <td colspan="2" styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td colspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">What are the ingredients in FluMist?</content> </paragraph> <paragraph> <content styleCode="underline">Active Ingredient</content>: FluMist contains 3 influenza virus strains that are weakened (A(H1N1), A(H3N2), and B Victoria lineage).</paragraph> <paragraph> <content styleCode="underline">Inactive Ingredients</content>: FluMist also contains monosodium glutamate, gelatin, arginine, sucrose, dibasic potassium phosphate, monobasic potassium phosphate, and gentamicin.</paragraph> <paragraph>FluMist does not contain preservatives.</paragraph> </td> </tr> <tr> <td colspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">How is FluMist stored?</content> </paragraph> <paragraph>If you are giving FluMist to yourself or someone else, read the storage information in the “Instructions for Use” that comes with FluMist. </paragraph> <paragraph> <content styleCode="bold">Keep FluMist out of the reach of children.</content> </paragraph> </td> </tr> <tr> <td colspan="2" styleCode="Rrule Lrule " valign="top"> <paragraph>If you would like more information about FluMist, talk to your healthcare provider or visit <linkHtml href="https://www.flumist.com/">www.FluMist.com</linkHtml> or call 1-877-633-4411.</paragraph> <paragraph>FluMist<sup>®</sup> is a registered trademark of MedImmune, LLC.</paragraph> <paragraph>Other brands listed are registered trademarks of their respective owners and are not trademarks of MedImmune, LLC.</paragraph> </td> </tr> <tr> <td colspan="2" styleCode="Rrule Lrule " valign="top"> <renderMultiMedia ID="id886529488" referencedObject="ID_80551e9e-ec3b-494d-a162-a85279f2df4c"/> </td> </tr> <tr> <td colspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Manufactured by:</paragraph> <paragraph>MedImmune, LLC</paragraph> <paragraph>Gaithersburg, MD 20878</paragraph> <paragraph>Issue date: August 2025</paragraph> <paragraph>RAL-FLUV16</paragraph> </td> </tr> <tr> <td colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>This Patient Information has been approved by the U.S. Food and Drug Administration.</paragraph> <paragraph>Issued: August 2025</paragraph> </td> </tr> </tbody> </table> </text> <effectiveTime value="20250701"/> <component> <observationMedia ID="ID_80551e9e-ec3b-494d-a162-a85279f2df4c"> <text>medimmune_image</text> <value mediaType="image/jpeg"> <reference value="medImmune_image.jpg"/> </value> </observationMedia> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_343280de-65ab-48f8-81b9-c161940b45df"> <id root="343280de-65ab-48f8-81b9-c161940b45df"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <text> <table width="100%"> <col width="24%"/> <col width="27%"/> <col width="11%"/> <col width="38%"/> <tbody> <tr> <td align="center" colspan="4" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">INSTRUCTIONS FOR USE</content> </paragraph> <paragraph> <content styleCode="bold">FluMist® (FLEW-mĭst)</content> </paragraph> <paragraph> <content styleCode="bold">(Influenza Vaccine Live, Intranasal)</content> </paragraph> <paragraph> <content styleCode="bold">Nasal Spray</content> </paragraph> </td> </tr> <tr> <td colspan="4" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>This Instructions for Use contains information on how to use FluMist. Even if you have previously used FluMist, there may be new information. This information does not take the place of talking to a healthcare provider about whether to use FluMist. </paragraph> <paragraph>If you or your caregiver have any questions, talk to a healthcare provider or call MedImmune information center 1-877-633-4411.</paragraph> <paragraph> <content styleCode="bold">Unfold to view full Instructions for Use</content> </paragraph> </td> </tr> <tr> <td colspan="4" styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td align="center" colspan="4" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Each FluMist Nasal Sprayer Contains 1 Dose (2 Sprays)</content> </paragraph> </td> </tr> <tr> <td align="center" colspan="2" styleCode="Lrule Botrule " valign="middle"> <paragraph> <content styleCode="bold">1 Dose = 2 Sprays<br/> </content> </paragraph> <paragraph>1 spray for each nostril.</paragraph> </td> <td colspan="2" styleCode="Rrule Toprule Botrule " valign="middle"> <renderMultiMedia ID="id194040778" referencedObject="e7236f2e-6b5c-4479-baf6-6e090036cf31"/> </td> </tr> <tr> <td align="center" colspan="2" styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph> <content styleCode="bold">IMPORTANT:</content> </paragraph> </td> <td colspan="2" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph> <content styleCode="bold">DO NOT</content> remove the dose divider clip </paragraph> <paragraph>until <content styleCode="bold">Spray 2</content> (Step 9).</paragraph> </td> </tr> <tr> <td align="center" colspan="4" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Important Information You Need to Know Before Using FluMist</content> </paragraph> </td> </tr> <tr> <td colspan="4" styleCode="Rrule Lrule Botrule " valign="top"> <list listType="unordered"> <item> <caption>•</caption>A caregiver should administer FluMist to individuals 2 through 17 years of age.</item> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> use FluMist if:<list listType="unordered"> <item> <caption>‒</caption>It has been frozen.</item> <item> <caption>‒</caption>It has been dropped and/or damaged.</item> <item> <caption>‒</caption>The carton has been opened, damaged, or appears tampered with.</item> <item> <caption>‒</caption>The expiration date (EXP) has passed.</item> </list> </item> </list> <paragraph>If any of the above happens, follow <content styleCode="bold">Step 13</content> and contact MedImmune or your healthcare provider.</paragraph> <list listType="unordered"> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> use FluMist in the eyes, mouth, or on your skin.</item> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> share FluMist with anyone or reuse the sprayer.</item> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> inject FluMist.</item> </list> <paragraph> <content styleCode="bold">Contact MedImmune or your healthcare provider if you have any questions.</content> </paragraph> </td> </tr> <tr> <td align="center" colspan="4" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Storing FluMist</content> </paragraph> </td> </tr> <tr> <td colspan="4" styleCode="Rrule Lrule Botrule " valign="top"> <list listType="unordered"> <item> <caption>•</caption>Keep FluMist and all medicines out of reach of children.</item> <item> <caption>•</caption>Store FluMist in a refrigerator between 35°F to 46°F (2°C to 8°C) in its carton to protect from light until you are ready to use it.</item> <item> <caption>•</caption>FluMist may be kept at room temperature between 68°F to 77°F (20°C to 25°C) in its carton for a maximum of 12 hours.</item> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> freeze FluMist.</item> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> expose FluMist to temperatures greater than 77°F (25°C).</item> </list> </td> </tr> <tr> <td align="center" colspan="4" styleCode="Rrule Lrule Botrule " valign="top"> <renderMultiMedia ID="id-1064254157" referencedObject="abea00d9-17dc-4c3f-8575-5a2def7a508c"/> </td> </tr> <tr> <td align="center" colspan="4" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Preparing to Use FluMist</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <renderMultiMedia ID="id-1017378768" referencedObject="ID_2bbf5888-f1cb-47cb-a52c-a86d201da1d6"/> </td> <td colspan="3" styleCode="Rrule Toprule Botrule " valign="top"> <paragraph>Remove the FluMist carton from the refrigerator and place on a clean flat surface.</paragraph> <list listType="unordered"> <item> <caption>•</caption>Use FluMist within <content styleCode="bold">12 hours</content> of removing from the refrigerator.</item> </list> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <renderMultiMedia ID="id-332377111" referencedObject="ID_0b202754-88a4-4618-b797-88169148eb3d"/> </td> <td colspan="3" styleCode="Rrule Toprule Botrule " valign="top"> <paragraph>Check the carton.</paragraph> <list listType="unordered"> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> use FluMist if the expiration (EXP) date has passed.</item> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> use if the carton has been opened, damaged, or appears tampered with.</item> </list> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <renderMultiMedia ID="id1785765030" referencedObject="ab280a28-3c21-4d6c-8a24-c7702b8e37a7"/> </td> <td colspan="3" styleCode="Rrule Toprule Botrule " valign="top"> <paragraph>Open the carton and remove the FluMist sprayer by holding onto the sprayer body.</paragraph> <list listType="unordered"> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> hold the sprayer by any other parts.</item> </list> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <renderMultiMedia ID="id884600588" referencedObject="ID_418cdb78-9b62-4870-a220-9e99f8904793"/> </td> <td colspan="3" styleCode="Rrule Toprule Botrule " valign="top"> <paragraph>Check the FluMist sprayer. </paragraph> <list listType="unordered"> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> use FluMist if the expiration (EXP) date on the label has passed or if the sprayer appears damaged.</item> </list> <paragraph>Check the liquid in the sprayer. </paragraph> <list listType="unordered"> <item> <caption>•</caption>The liquid should be colorless to pale yellow and clear to slightly cloudy. </item> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> use if the liquid appears discolored.</item> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> attempt to remove bubbles from the sprayer.</item> </list> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <renderMultiMedia ID="id66854716" referencedObject="ID_54d3dda3-28ab-4cad-b74e-831946bf5b03"/> </td> <td align="center" colspan="3" styleCode="Rrule Toprule Botrule " valign="middle"> <paragraph> <content styleCode="bold">Spray 1</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <renderMultiMedia ID="id-2036568419" referencedObject="ID_95d5fd70-bbd8-4805-baea-5199e64685cd"/> </td> <td colspan="3" styleCode="Rrule Toprule Botrule " valign="top"> <paragraph>Hold on to the sprayer body and pull off the gray cap.</paragraph> <list listType="unordered"> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> remove the dose divider clip until <content styleCode="bold">Step 9</content>.</item> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> push or pull the plunger.</item> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> prime or remove bubbles from the sprayer.</item> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> insert the sprayer into nostril before removing the cap.</item> </list> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <renderMultiMedia ID="id1720402679" referencedObject="ID_7b83ec4a-7a7b-4e2d-8462-4ba8d485e594"/> </td> <td colspan="3" styleCode="Rrule Toprule Botrule " valign="top"> <paragraph> <content styleCode="bold">Keeping head in upright position,</content> place just the sprayer tip inside one nostril. The sprayer tip does not need to be inserted far into the nose.</paragraph> <list listType="unordered"> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> insert the entire white tip inside the nostril.</item> </list> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <renderMultiMedia ID="id1965683927" referencedObject="ff33e67e-83bd-4d6a-8fd9-1b798e28e605"/> </td> <td colspan="3" styleCode="Rrule Toprule Botrule " valign="top"> <paragraph>Administer <content styleCode="bold">Spray 1</content> by pushing the plunger as quickly as possible until it stops at the dose divider clip.</paragraph> <list listType="unordered"> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> remove sprayer until the plunger has stopped.</item> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> remove the dose divider clip until <content styleCode="bold">Step 9</content>.</item> <item> <caption>•</caption>Breathe normally. There is no need to inhale or sniff.</item> <item> <caption>•</caption>It is normal if you feel a slight tickle or experience some dripping or sneezing.</item> </list> </td> </tr> <tr> <td rowspan="3" styleCode="Lrule Botrule " valign="top"> <renderMultiMedia ID="id-897519073" referencedObject="ID_855766f2-cc21-463a-9063-7856af3a349b"/> </td> <td colspan="3" styleCode="Rrule Toprule Botrule " valign="top"> <paragraph>Remove the sprayer from the first nostril.</paragraph> <list listType="unordered"> <item> <caption>•</caption>Wipe away any liquid that drips from the nose with a tissue.</item> </list> </td> </tr> <tr> <td colspan="2" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> <content styleCode="bold">IMPORTANT:</content> </paragraph> </td> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>Continue to <content styleCode="bold">Spray 2</content> (Step 9) to remove the dose divider clip.</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Toprule Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <renderMultiMedia ID="id1996136635" referencedObject="ID_89c13b12-5046-405e-b98d-6bde53340b45"/> </td> <td align="center" colspan="3" styleCode="Rrule Toprule Botrule " valign="middle"> <paragraph> <content styleCode="bold">Spray 2</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <renderMultiMedia ID="id2031296231" referencedObject="ID_0fddbea4-40a4-4f43-8b16-3475ebd4b17f"/> </td> <td colspan="3" styleCode="Rrule Toprule Botrule " valign="top"> <paragraph>Holding onto the sprayer body, pinch and remove the dose divider clip from plunger.</paragraph> <list listType="unordered"> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> push or pull the plunger.</item> </list> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <renderMultiMedia ID="id1986653401" referencedObject="fbcb0d4e-ba62-4a1a-9214-ecb640da5e5b"/> </td> <td colspan="3" styleCode="Rrule Toprule Botrule " valign="top"> <paragraph> <content styleCode="bold">Keeping head in upright position</content>, place just the sprayer tip inside the <content styleCode="bold">other nostril</content>. The sprayer tip does not need to be inserted far into the nose.</paragraph> <list listType="unordered"> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> insert the entire white tip inside the nostril.</item> </list> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <renderMultiMedia ID="id1019584390" referencedObject="c889d6b5-40e9-4baa-a59d-1b825dadfdd0"/> </td> <td colspan="3" styleCode="Rrule Toprule Botrule " valign="top"> <paragraph>Administer <content styleCode="bold">Spray 2</content> by pushing the plunger as quickly as possible until it stops.</paragraph> <list listType="unordered"> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> remove sprayer until the plunger has stopped.</item> <item> <caption>•</caption>Breathe normally. There is no need to inhale or sniff.</item> <item> <caption>•</caption>It is normal if you feel a slight tickle or experience some dripping or sneezing.</item> </list> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <renderMultiMedia ID="id996690750" referencedObject="ID_15bb7a29-9c83-4422-946c-7a1a413494a3"/> </td> <td colspan="3" styleCode="Rrule Toprule Botrule " valign="top"> <paragraph>Remove the sprayer from the second nostril.</paragraph> <list listType="unordered"> <item> <caption>•</caption>Wipe away any liquid that drips from the nose with a tissue.</item> </list> </td> </tr> <tr> <td colspan="4" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Dispose of used sprayer through return shipment program.</content> </paragraph> <paragraph>Follow the return shipment program steps outlined in the separate directions that were provided with your FluMist dose. </paragraph> <list listType="unordered"> <item> <caption>•</caption>FluMist contains a single dose and <content styleCode="bold">cannot be reused</content>.</item> <item> <caption>•</caption> <content styleCode="bold">DO NOT</content> dispose of your used sprayer in your household trash.</item> </list> <paragraph>If you or your caregiver have any questions, talk to your healthcare provider or call 1-877-633-4411.</paragraph> </td> </tr> <tr> <td colspan="4" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Manufactured by</content>: MedImmune, LLC, Gaithersburg, MD 20878</paragraph> <paragraph>U.S. Government License No. 1799</paragraph> </td> </tr> <tr> <td colspan="4" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>This Instructions for Use has been approved by the U.S. Food and Drug Administration. </paragraph> <paragraph>Approved: September 2024</paragraph> </td> </tr> </tbody> </table> <paragraph/> </text> <effectiveTime value="20250701"/> <component> <observationMedia ID="e7236f2e-6b5c-4479-baf6-6e090036cf31"> <text>spray1_and_spray2</text> <value mediaType="image/jpeg"> <reference value="spray1_and_spray2.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="abea00d9-17dc-4c3f-8575-5a2def7a508c"> <text>carton_and_nasal_sprayer</text> <value mediaType="image/jpeg"> <reference value="caarton_nasal_sprayer.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_2bbf5888-f1cb-47cb-a52c-a86d201da1d6"> <text>step1</text> <value mediaType="image/jpeg"> <reference value="step1.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_0b202754-88a4-4618-b797-88169148eb3d"> <text>step_2</text> <value mediaType="image/jpeg"> <reference value="step_2.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ab280a28-3c21-4d6c-8a24-c7702b8e37a7"> <text>step_3</text> <value mediaType="image/jpeg"> <reference value="step_3.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_418cdb78-9b62-4870-a220-9e99f8904793"> <text>step_4</text> <value mediaType="image/jpeg"> <reference value="step_4.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_54d3dda3-28ab-4cad-b74e-831946bf5b03"> <text>nose_spray1</text> <value mediaType="image/jpeg"> <reference value="image-01.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_95d5fd70-bbd8-4805-baea-5199e64685cd"> <text>step_5</text> <value mediaType="image/jpeg"> <reference value="step_5.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_7b83ec4a-7a7b-4e2d-8462-4ba8d485e594"> <text>step_6</text> <value mediaType="image/jpeg"> <reference value="step_6.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ff33e67e-83bd-4d6a-8fd9-1b798e28e605"> <text>step_7</text> <value mediaType="image/jpeg"> <reference value="step_7.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_855766f2-cc21-463a-9063-7856af3a349b"> <text>step_8</text> <value mediaType="image/jpeg"> <reference value="step_8.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_89c13b12-5046-405e-b98d-6bde53340b45"> <text>step_9_nose_image</text> <value mediaType="image/jpeg"> <reference value="step_9_nose_image.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_0fddbea4-40a4-4f43-8b16-3475ebd4b17f"> <text>step_9</text> <value mediaType="image/jpeg"> <reference value="step_9.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="fbcb0d4e-ba62-4a1a-9214-ecb640da5e5b"> <text>step_10</text> <value mediaType="image/jpeg"> <reference value="step_10.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="c889d6b5-40e9-4baa-a59d-1b825dadfdd0"> <text>step_11</text> <value mediaType="image/jpeg"> <reference value="step_11.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_15bb7a29-9c83-4422-946c-7a1a413494a3"> <text>step_12</text> <value mediaType="image/jpeg"> <reference value="step_12.jpg"/> </value> </observationMedia> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_7c3f1378-4156-4830-841d-c03244aada32"> <id root="5d215ea1-28c9-4590-9728-67a9a38af9f9"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <title>PACKAGE/LABEL PRINCIPAL DISPLAY PANEL </title> <text> <paragraph>2025-2026 FORMULA</paragraph> <paragraph>Influenza Vaccine Live, Intranasal </paragraph> <paragraph>FluMist®</paragraph> <paragraph>STORE REFRIGERATED</paragraph> <paragraph>at 2º-8ºC (35º-46ºF)</paragraph> <paragraph>RX only</paragraph> <paragraph>For 2-49 years of age</paragraph> <paragraph>PROTECT FROM LIGHT</paragraph> <paragraph>FOR INTRANASAL USE</paragraph> <paragraph>Contents: 10 pre-filled sprayers</paragraph> <paragraph>One 0.2 mL dose each</paragraph> <paragraph>(0.1 mL per nostril)</paragraph> <paragraph>Manufactured by MedImmune, LLC.</paragraph> <paragraph>One MedImmune Way</paragraph> <paragraph>Gaithersburg, MD 20878 USA</paragraph> <paragraph>U.S. Govt. License No. 1799</paragraph> <paragraph>Product of the United Kingdom</paragraph> <paragraph>MedImmune</paragraph> <renderMultiMedia ID="id-1027020100" referencedObject="ID_83e60804-a38a-40b9-9d2c-0570c33be9b7"/> </text> <effectiveTime value="20250701"/> <component> <observationMedia ID="ID_83e60804-a38a-40b9-9d2c-0570c33be9b7"> <text>carton-10-prefilled-sprayers</text> <value mediaType="image/jpeg"> <reference value="carton-10-prefilled-sprayers.jpg"/> </value> </observationMedia> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_0762bb04-0766-4bae-93be-dd9546a9a88d"> <id root="0762bb04-0766-4bae-93be-dd9546a9a88d"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <title>Package/Label Display Panel </title> <text> <paragraph>2025-2026 FORMULA</paragraph> <paragraph>Influenza Vaccine Live, Intranasal </paragraph> <paragraph>FluMist<sub>®</sub> </paragraph> <paragraph>FOR INTRANASAL USE</paragraph> <paragraph>1 nasal sprayer containing 1 dose.</paragraph> <paragraph>1 dose is 2 sprays (1 spray for each nostril).</paragraph> <paragraph>STORE FluMist sprayer refrigerated</paragraph> <paragraph>at 35ºF to 46ºF (2ºC to 8ºC) in </paragraph> <paragraph>original carton to protect from light.</paragraph> <paragraph>Do not freeze. Do not expose</paragraph> <paragraph>to temperatures greater than 77ºF (25ºC).</paragraph> <paragraph>Keep out of reach of children. </paragraph> <paragraph>Manufactured by MedImmune, LLC.</paragraph> <paragraph>One MedImmune Way</paragraph> <paragraph>Gaithersburg, MD 20878 USA</paragraph> <paragraph>U.S. Govt. License No. 1799</paragraph> <paragraph>Product of the United Kingdom</paragraph> <paragraph>MedImmune</paragraph> <renderMultiMedia ID="id-1791730069" referencedObject="ID_78bb5531-ab0d-4c2a-9c56-760de26b7b19"/> </text> <effectiveTime value="20250701"/> <component> <observationMedia ID="ID_78bb5531-ab0d-4c2a-9c56-760de26b7b19"> <text>flumist-1sprayer-home-admin-carton</text> <value mediaType="image/jpeg"> <reference value="flumist-1sprayer-home-admin-carton.jpg"/> </value> </observationMedia> </component> </section>

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