Pfizer To Seek FDA Approval For COVID Vaccine In Children Under 5 Years

(RTTNews) - Drug giant Pfizer Inc. (PFE) is expected to ask the US Food and Drug Administration to approve the company's Covid-19 vaccine for children age 6 months up to 5 years as soon as Tuesday, as per reports.

According to news reports, Pfizer is expected to ask the agency to grant emergency use authorization for a two-dose regimen of its product even as it continues to test three doses in this younger age group. Pfizer was encouraged to seek authorization for the two doses by the US FDA who expect to grant the authorization by late February. Waiting on data for all the three doses could extend the wait until March, said reports.

The Pfizer/BioNTech vaccine has already secured authorization for use in people as young as 5 years old and if authorized, this vaccine would be the first one available for the young ones. In December, Pfizer extended its vaccine in trial in younger children after two child-sized doses of the vaccine did not bring about the needed immunity in the 2-5-year-olds, although it did in babies up to age 2. The company said it would change the trial to add a third 3-microgram dose at least two months after the second. A Pfizer spokesperson told the media on Monday the company has till now not submitted a request to the FDA and said the company is "continuing to collect and analyze data from both two and three doses in our younger age cohort." Scott Gottlieb, a former commissioner of the US FDA and current Pfizer board member, recently said that if the vaccine was two doses instead of three, it could receive emergency use authorization by early March. Talking to CNN he said, "I'm hopeful that you could see some movement on trying to entertain that application earlier. Ultimately the decision resides with the FDA, but there is some indication that there may be an earlier action on that application.

Gottlieb further went on to say, "If the goal of the vaccine is to get baseline immunity in the kids to prevent really bad outcomes and you're really not using the vaccine as a tool to prevent infection in the first place two doses would be enough. I think that may be why federal health officials are rethinking this. If in fact, they decide to authorize this on the basis of two doses, it could be out much sooner, perhaps as early as early March."