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 Coronavirus vaccines for children younger than 5 could be available
as soon as end-February under a plan that would lead to the
potential authorization of a two-shot regimen in the coming weeks,
the Post reported, citing people briefed on the situation.
The 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 holds 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, BioNTech and the FDA did not immediately respond to Reuters
requests for comment.
[to top of second column] |
 Pfizer said in January it expected the latest
results from a clinical trial for kids under the
age of 5 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.
The company amended the study because children
between the ages of 2 and 4 who were given two
3-microgram doses of the vaccine did not have
the same immune response that a larger dose of
the vaccine generated in older children.
(Reporting by Juby Babu and Akriti Sharma in
Bengaluru; Editing by Richard Pullin and
Shailesh Kuber)
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