Pfizer Submits Childhood Vaccine To FDA For 'Initial Review'

What is the status of the coronavirus vaccine for children?

The Pfizer-BioNTech vaccine is the closest to being approved for children, as the two companies announced Tuesday of this week they submitted data on their vaccine for children ages 5-11 to the U.S. Food and Drug Administration (FDA).

However, this is only for initial review; Pfizer has not yet asked the FDA to give emergency-use authorization. Pfizer said this is the first step and "a formal submission to request emergency use authorization (EUA) is expected to follow in the coming weeks."

Pfizer said it will make the same request to the European Medicines Agency (EMA) and other regulatory authorities.

Meanwhile, Gov. Gavin Newsom just announced Friday that California will be the first state in the nation to require children get the vaccine to go to school. He will require that all children 12-17 get the vaccine once the FDA grants it full approval; right now it has only been approved under EUA status.

As Patch previously reported, Pfizer announced Sept. 20 it saw positive results from its COVID-19 vaccine childhood trials, particularly using a lower dose for children spread out over two shots.

"In the trial, which included 2,268 participants 5 to <12 years of age, the vaccine demonstrated a favorable safety profile and elicited robust neutralizing antibody responses using a two-dose regimen of 10 microgram doses," said Pfizer.

Anyone older than 12 who got the Pfizer vaccine received 30 micrograms in two shots.

In total, Pfizer tested up to 4,500 children ages 6 months to 11 years old in the United States, Finland, Poland and Spain for their COVID vaccine.

They broke their trial up into three parts: Ages 5 to 11 years; ages 2 to 5 years; and ages 6 months to 2 years. There were 2,268 participants enrolled in the 5-11 age group.

Pfizer said the trial results showed them that 10 micrograms is the "preferred dose" for children 5 to 11 years of age.

Pfizer said its results from its other two phases of the trial, children 2-5 years old and children 6 months-2 years old, are expected as soon as the fourth quarter of 2021.

Here in New Jersey, Rutgers has 100 children ages 5 to 11 enrolled in the Pfizer-BioNTech trial. It is the only Pfizer COVID-19 clinical trial site for children in New Jersey.

In late September, former FDA commissioner Dr. Scott Gottlieb predicted that the FDA could approve the Pfizer vaccine for kids 5-11 by Halloween.

"In a best-case scenario, given that timeline they've just laid out, you could potentially have a vaccine available to children aged 5 to 11 by Halloween," said Gottlieb, who currently sits on Pfizer's board of directors. "If everything goes well, the Pfizer data package is in order, and FDA ultimately makes a positive determination, I have confidence in Pfizer in terms of the data that they've collected."

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