Pfizer Asks FDA To Greenlight Covid Vaccine For Children Under 5

Topline

Pfizer has asked the Food and Drug Administration to authorize its three-dose Covid-19 vaccine for children under 5, the company announced Wednesday evening, a move that could extend protection against the coronavirus to the U.S.’s 18 million young children.

A child receives vaccination against influenza.

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Key Facts

The request came just days after Pfizer and BioNTech published clinical trial results indicating three low-dose shots of their coronavirus vaccine produces a “strong immune response” among children under 5.

The FDA said it plans to review the application “as quickly as possible” but could not give a timeframe for when it would be done, ABC News reported.

In April, Moderna also asked the FDA to grant emergency authorization for its own coronavirus vaccine for children ages 6 months to 5 years.

What To Watch For

At its June 14-15 meeting, the FDA’s advisory panel on vaccines will discuss the possibility of extending Pfizer-BioNTech’s vaccine to children ages 6 months to 4 years. The committee’s recommendations aren’t binding, but the FDA’s approval decisions often align with the panel’s.

Key Background

Pfizer and BioNTech’s emergency use authorization application came after months of delays. In February, the FDA asked Pfizer to submit data on the first two doses of its three-dose course for infants and young children, in a move Pfizer CEO Albert Bourla said could allow parents to begin vaccinating their children while authorization of a third dose was pending. However, FDA evaluation of Pfizer’s first two doses was delayed in order to give the company and regulators more time to gather and review data. No Covid-19 vaccines are currently approved for U.S. children under 5, but the U.S. already has enough doses to vaccinate all 18 million children in that age range, according to the American Hospital Association.

Big Number

80.3%. That’s how effective Pfizer-BioNTech’s vaccine is at preventing Covid-19 among children ages 6 months to 4 years, according to research by Pfizer.

Tangent

Pfizer and BioNTech also plan to submit data supporting their vaccine’s usefulness for young children to the European Medicines Agency and other international regulators, Pfizer said in a statement.