Pfizer, BioNTech ask FDA to authorize two-dose COVID-19 vaccine for children under 5

Benjamin Hayes, age 5, at Children's National Hospital in Washington, DC.

Children’s National Hospital

• Pfizer and BioNTech officially asked the FDA to authorize a 2-dose vaccine regimen for kids under 5.
• The move comes after reports suggested shots for young kids could be available by the end of February.
• Pfizer and BioNTech will continue researching whether 3 doses might be more effective.

Pfizer and its manufacturer BioNTech on Tuesday submitted an official request asking the US Food and Drug Administration to authorize a two-dose COVID 19 vaccine for children ages six months to five years old. 

The move comes one day after The Washington Post reported that inoculations for younger kids could be available by the end of February, a possible deadline much sooner than previously thought. 

As regulators work to review the application, Pfizer and BioNTech will continue researching whether three doses of the vaccine might be more effective for younger children after two shots failed to produce the desired immunity response among kids aged two to four in a clinical trial late last year.

In a Tuesday press release, the FDA said the agency pushed Pfizer and BioNTech to submit the application given the ongoing Omicron surge — an unusual move in light of the clinical trial's failures.

"Having a safe and effective vaccine available for children in this age group is a priority for the agency and we're committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge,"acting FDA commissioner Janet Woodcock, said in a press release.

"Furthermore, children are not small adults. Because they're still growing and developing, it's critical that these vaccines are evaluated in well-designed and well-conducted clinical trials," she added.

The previous clinical trial found that only children between six months and two years old achieved an immunity level comparable to older teens and young adults when given a dose equal to one-tenth the strength of the adult dose. 

Pfizer and BioNTech on Tuesday said they are submitting data to the FDA on a rolling basis in an effort to fast-track an approval. According to a Pfizer press release, the proposed two-dose regimen will eventually be a three-dose vaccine for younger children, as the companies aim to have data on a third shot submitted to the agency in the next few months.

While kids under five will eventually require a third dose to reach peak immunity, the company said FDA approval of the two-dose regimen will allow parents to begin the inoculation process for their children while they wait for the third shot. 

Children under five are the only remaining age group not yet eligible for a COVID-19 vaccine. The cohort includes nearly 19 million kids. 

While young kids face much less risk of severe COVID compared to adults, the most recent Omicron surge has sparked a rise in pediatric hospitalizations, 

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