Pfizer COVID vaccines safe and effective for small children, FDA staff
say
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[June 13, 2022]
(Reuters) - U.S. Food and Drug
Administration staff reviewers on Sunday said Pfizer-BioNTech's COVID-19
vaccines were effective and safe for use in children aged 6 months to 4
years.
The FDA reviewers said in briefing documents published on Sunday evening
that their evaluation did not reveal any new safety concerns related to
the use of the vaccine in young children.
The FDA analysis of data from Pfizer's trial was published ahead of a
June 15 meeting of its outside advisers. Recommendations from the
external advisers will determine the FDA's decision on the vaccines.
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"Available data support the effectiveness of the Pfizer-BioNTech
COVID-19 Vaccine 3-dose primary series in preventing COVID-19 in the age
group of 6 months through 4 years," FDA staff said in the review.
An early analysis of data from Pfizer-BioNTech's vaccine based on 10
symptomatic COVID-19 cases identified when the Omicron coronavirus
variant was dominant suggested a vaccine efficacy of 80.3% in the
under-5 age group.
COVID-19 shots for children under the age of 6 are
yet not approved in most parts of the world. It remains unclear how many
parents will get their young ones vaccinated as demand has been low for
kids aged 5 to 11.
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![](../images/061322PIX/news_l21.jpg)
A child reacts while receiving a dose of the Pfizer-BioNTech
coronavirus disease (COVID-19) vaccine at Smoketown Family Wellness
Center in Louisville, Kentucky, U.S., November 8, 2021. REUTERS/Jon
Cherry/File Photo
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U.S. President Joe Biden's administration expects vaccinations for
young children to begin in earnest as early as June 21 if the FDA
and the Centers for Disease Control and Prevention approve the
vaccines.
Government officials say pre-orders for use in the under-6 age group
has been low but demand is expected to pick up once the vaccines
gain authorization.
The FDA on Friday released a staff review of Moderna Inc's COVID-19
vaccine which said the doses were safe and effective for use in
children aged 6 months to 17 years old.
(Reporting by Manas Mishra and Ann Maria Shibu in Bengaluru; Editing
by Vinay Dwivedi and Edwina Gibbs)
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