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Pfizer, BioNTech ask FDA to authorise two-dose Covid-19 vaccine for children under 5

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

Pfizer and its manufacturer BioNTech on Tuesday submitted an official request asking the US Food and Drug Administration to authorise 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 December 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. 

This story is a developing story.

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