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.
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.
