FDA Moving to Authorize Pfizer-BioNTech Booster for 16-, 17-Year-Olds – The Wall Street Journal

The Food and Drug Administration could authorize Covid-19 boosters from

Pfizer Inc.

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BioNTech SE

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for use in 16- and 17-year olds as soon as next week as concerns rise over a new, possibly more transmissible variant, according to a person familiar with the planning.

The agency is planning to move rapidly to take action on a request by the companies to authorize boosters for 16- and-17 year olds, according to a person familiar with the matter. So far, only people 18 years and older are eligible for boosters.

Pressure has been mounting on the Biden administration to authorize boosters, especially in light of the emergence of Omicron, a new variant with a worrying constellation of mutations that could reduce the efficacy of vaccines.

Vaccine makers have begun racing to assess whether their shots work as well against Omicron as against other variants, or whether they will need to modify the doses to target the new strain.

President Biden said Monday that his administration was working with officials at Pfizer, Moderna and Johnson & Johnson to develop contingency plans for vaccines or boosters in case they are needed to combat the Omicron variant. Photo: Oliver Contreras/Bloomberg

The Centers for Disease Control and Prevention on Monday recommended that everyone 18 and older get an additional shot after completing a primary series of Covid-19 vaccination. The agency said earlier this month that people under 50 years could get an additional dose and encouraged vaccination for those 50 and above.

President Biden said Monday that his administration was working with the vaccine makers on any plans for vaccines to deal with the new variant if necessary.

The FDA has authorized use of the Pfizer-BioNTech vaccine in children ages 5 to 15 years. In August, it was fully approved for individuals who are 16 years of age and older. That means some 16- and 17-year-olds were vaccinated more than six months ago, making them eligible for a booster if authorized.

In August, Pfizer and BioNTech sought clearance of boosters for people 16 years and older, but at the time the agency limited the extra doses to the elderly and adults who were at high risk after outside scientific advisers said they weren’t convinced that broad boosters were necessary.

The Washington Post earlier reported that Pfizer and BioNTech are expected to ask the FDA for the booster authorization, and the New York Times said the authorization could happen within a week.

About 50% of people 12 to 17 years old have been fully vaccinated in the U.S., according to the CDC, and about 60% of people in that demographic have had at least one dose.

The 16- and 17-year olds are at lower risk of developing severe disease if infected than older people, according to researchers, but higher numbers among teens have become sick in recent months compared with earlier in the pandemic.

Write to Stephanie Armour at stephanie.armour@wsj.com and Jared S. Hopkins at jared.hopkins@wsj.com

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