Pfizer must apply for authorization from the US Food and Drug Administration (FDA), an agency similar to Anvisa, later this Tuesday (1st) for the Covid-19 vaccine for children aged 6 months to 5 years, said a person familiar with the matter. with the plan.
The company will ask the agency to grant emergency use authorization for a two-dose regimen, while continuing to test three doses in this younger age group, the source said.
Pfizer has been encouraged to seek authorization for both doses by federal regulators, which they hope can be granted by the end of February. Waiting for data for three doses could extend the wait until March.
Pfizer’s vaccine is already authorized for use in people age 5 and older, and if authorized, this vaccine would be the first Covid-19 vaccine available to younger children.
The development of this timeline was first reported by the Washington Post.
In December, Pfizer extended testing of the immunizer to younger children after two doses failed to produce the expected immunity in children aged 2 to 5 years, although it did so for babies as young as 2 years. The company said it would “alter” the test to add a third 3-microgram dose at least two months after the second.
A Pfizer spokesperson told CNN international on Monday (31) that the company has not yet submitted an application to the FDA and said that the company “continues to collect and analyze data from two and three doses in our youngest cohort”. The Food and Drug Administration did not respond to a request for comment from the CNN.
Researcher Scott Gottlieb, former commissioner of the U.S. Food and Drug Administration and current board member at Pfizer, said on Sunday that if the vaccination schedule is two doses instead of three, the immunizer may receive authorization for use. emergency in early March.
“Hopefully you can see some movement in trying to get this submission sooner,” Gottlieb said on CBS’s “Face the Nation.” “Ultimately, the decision rests with the FDA, but there is some indication that there may be earlier action on this request.”
“If the goal of the vaccine is to get basic immunity in children — to avoid really bad outcomes and you’re not really using the vaccine as a tool to prevent infection in the first place — two doses can do that,” Gottlieb said. “I think that may be why federal health officials are rethinking this. If, in fact, they decide to authorize use on a two-dose basis, it could be approved much sooner, perhaps early March.”
CNN’s Carma Hassan and Amanda Sealy contributed to this story.
Source: CNN Brasil
