(CMR) Pfizer and its partner, BioNTech, are expected to submit to the Food and Drug Administration a request for emergency-use authorization for the COVID-19 vaccine for children 6 months to 4 years old. This would make it the first vaccine available for that age group. Children 5 and older already can receive the shot.
Regulators are reportedly asking for data from a two-dose vaccine regimen, potentially leading to approval within the coming weeks. If approved, the Coronavirus vaccine for this age group could be available by the end of February.
The FDA urged the companies to submit the application so that regulators could begin reviewing the two-shot data.
The companies have been testing a third dose in the last few months, following disappointing results for the two-shot regimen showing that while the vaccine is safe, two doses did not provide a strong enough immune response in all age groups. But data on a third shot will not be available until at least late March. Once that information is submitted, regulators are expected to authorize a third dose of the pediatric vaccine.
“We know that two doses isn’t enough, and we get that. The idea is, let’s go ahead and start the review of two doses. 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,” a source told Washington Post.