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

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