FDA urges Pfizer to apply for authorization of Covid vaccine for children under five

Move could clear way for two-dose regimens to begin as soon as end of February, while companies await data on three-dose course

1
245

Guardian: US regulators are urging Pfizer to apply for emergency authorization for a two-dose regimen of its Covid-19 vaccine for children six months to five years old, according to sources.

The move could clear the way for the shots as soon as the end of February, while the companies await data on a three-dose course.

The Washington Post reported that Pfizer and Germany’s BioNTech are expected to submit the request as early as Tuesday to the US Food and Drug Administration (FDA), which has encouraged the submission. It would then return for additional authorization once the data on a three-dose course is available, a person familiar with the matter told the Associated Press.

The Post report says that the FDA urged the companies to submit the application so that regulators could begin reviewing the two-shot data. “The idea is, let’s go ahead and start the review of two doses,” the report quoted one of the people familiar with the situation as saying.



“If the data hold up in the submission, you could start kids on their primary baseline months earlier than if you don’t do anything until the third-dose data comes in.”

Pfizer said in January it expected the latest results from a clinical trial for kids under the age of five by April, after it amended its study to give a third dose to everybody who’s less than five at least eight weeks after their last vaccination.  Read more…

https://www.theguardian.com/world/2022/feb/01/fda-urges-pfizer-to-apply-for-authorization-of-covid-vaccine-for-children-under-five

ATTENTION READERS

We See The World From All Sides and Want YOU To Be Fully Informed
In fact, intentional disinformation is a disgraceful scourge in media today. So to assuage any possible errant incorrect information posted herein, we strongly encourage you to seek corroboration from other non-VT sources before forming an educated opinion.

About VT - Policies & Disclosures - Comment Policy
Due to the nature of uncensored content posted by VT's fully independent international writers, VT cannot guarantee absolute validity. All content is owned by the author exclusively. Expressed opinions are NOT necessarily the views of VT, other authors, affiliates, advertisers, sponsors, partners, or technicians. Some content may be satirical in nature. All images are the full responsibility of the article author and NOT VT.

1 COMMENT

Comments are closed.