The FDA has amended the Pfizer emergency use authorization to:
❇️ Expand the use of booster doses to kids aged 12-15 years
❇️ Shorten the recommended time between second and booster dose to 5 months (instead of 6) in those aged 12 years and older
❇️ Allow kids 5-11 who have certain immunocompromising conditions to get a third dose
About the booster dose for kids aged 12-15 years…
⚈ The FDA reviewed safety data from 6300 kids aged 12-15 years in Israel who received a booster dose at least 5 months after their second dose.
⚈ There were no new safety concerns after a booster was given, including NO new cases of myocarditis or pericarditis reported in these kids to date.
⚈ The FDA determined the protective benefits of the booster to provide continued protection against serious illness, hospitalization and death outweigh any known and potential risks.
About the shorter interval between second dose and booster in those aged 12 + years…
⚈ The FDA reviewed data from over 4.1 million individuals aged 16 years and older in Israel as well as other peer-reviewed data and determined a booster dose is safe and greatly improves antibody response.
⚈ Given the wide circulation of the omicron variant and the ability for increased antibody levels to increase protection, they determined that the potential benefits of getting a booster 5 months after the second dose outweighs any known and potential risks.
About the third dose in immunocompromised kids aged 5-11 years…
⚈ The FDA evaluated potential effectiveness of an additional dose in kids aged 5-11 years using data in adults and prior analyses conducted as part of the authorization process for healthy children.
⚈ They determined that the potential benefits of a third dose in kids aged 5-11 years, given at least 28 days after the second dose, outweighs any known and potential risks.
NOTE: Kids aged 5-11 years who are fully vaccinated and NOT immunocompromised do NOT need a third dose or booster at this time, but the FDA will continue to review available data and communicate any change in recommendations.
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