FDA Gives The Green Light Over New Vaccine

(FiveNation.com)- On Monday, the FDA granted emergency use authorization to Pfizer’s COVID-19 vaccine for children ages twelve to fifteen.

Late last year, Pfizer had received authorization for use on children sixteen and older.

“Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data as we have with all of our COVID-19 vaccine emergency use authorizations,” acting FDA Commissioner Janet Woodcock said in a statement.

By the end of April 2021, the CDC reports there were around 1.5 million COVID-19 cases reported among children ages eleven to seventeen. However, those infections tended to be milder.

There have been nearly 140 million doses of the Pfizer vaccine administered in the US so far – including children 16-years of age and older.

Though the emergency use authorization for children twelve to fifteen is now in effect, the FDA will not be meeting to discuss the use of COVID-19 vaccines in pediatric populations until next month.

“We recognize that the next critical step is having vaccines available for use throughout the pediatric population,” explained Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “As with the initial COVID-19 vaccine authorizations, we want to ensure that the public has a clear understanding of our expectations for the data and information needed to support requests for emergency use authorization and Biologics License Applications for vaccines intended to prevent COVID-19 in this pediatric age range.”

The Biologics License Application is the next step in receiving full regulatory approval from the FDA.

As yet, none of the COVID-19 vaccines have received full regulatory approval. However, last Friday Pfizer and BioNTech announced that they have submitted the Biologics License Applications and expect to receive full approval from the FDA within the next several months.