Covid-19

COVID-19

Pfizer Covid-19 vaccines safe and effective for small children, FDA staff say

Pfizer Covid-19 vaccines safe and effective for small children, FDA staff say
A Thai student gives the thumbs up as she receives a dose of Pfizer-BioNTech vaccine against Covid-19 during the second shots vaccination drive for children aged five to eight years, in Bangkok, Thailand, 18 May 2022. EPA-EFE/RUNGROJ YONGRIT

June 12 (Reuters) - U.S. Food and Drug Administration staff reviewers on Sunday said Pfizer-BioNTech's PFE.N, BNTX.O 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.

“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.

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 MRNA.O 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)

Gallery

"Information pertaining to Covid-19, vaccines, how to control the spread of the virus and potential treatments is ever-changing. Under the South African Disaster Management Act Regulation 11(5)(c) it is prohibited to publish information through any medium with the intention to deceive people on government measures to address COVID-19. We are therefore disabling the comment section on this article in order to protect both the commenting member and ourselves from potential liability. Should you have additional information that you think we should know, please email [email protected]"

Please peer review 3 community comments before your comment can be posted

A South African Hero: You

There’s a 99.7% chance that this isn’t for you. Only 0.3% of our readers have responded to this call for action.

Those 0.3% of our readers are our hidden heroes, who are fuelling our work and impacting the lives of every South African in doing so. They’re the people who contribute to keep Daily Maverick free for all, including you.

The equation is quite simple: the more members we have, the more reporting and investigations we can do, and the greater the impact on the country.

Be part of that 0.3%. Be a Maverick. Be a Maverick Insider.

Support Daily Maverick→
Payment options

MavericKids vol 3

How can a child learn to read if they don't have a book?

81% of South African children aged 10 can't read for meaning. You can help by pre-ordering a copy of MavericKids.

For every copy sold we will donate a copy to Gift of The Givers for children in need of reading support.