FDA Set to Authorize Pfizer Vaccine for Adolescents by Early Next Week


WASHINGTON — The Food and Drug Administration is preparing to authorize use of the Pfizer-BioNTech coronavirus vaccine in adolescents 12 to 15 years old by early next week, according to federal officials familiar with the agency’s plans, opening up the U.S. vaccination campaign to millions more people.

Some parents have been counting down the weeks since Pfizer announced results from its trial in adolescents showing that the vaccine is at least as effective in that age group as it is in adults. Vaccinating children is key to raising the level of immunity in the population and bringing down the numbers of hospitalizations and deaths.

The clearance, in the form of an amendment to the existing emergency use authorization for the Pfizer vaccine, could come as early as late this week. If it is granted, the Centers for Disease Control and Prevention’s vaccine advisory panel is likely to meet the following day to review the clinical trial data and make recommendations for the vaccine’s use in adolescents.

The expansion would be a major development in the country’s vaccination campaign and welcome news to some parents who are anxious to protect their children during summer activities and before the start of the next school year. It also poses another challenge to policymakers who are struggling to vaccinate a large percentage of adults hesitant to get the shot. Many more could refuse to inoculate their children.

“I do think we need to have a national and global conversation about the ethics of our vaccinating kids, who are low risk for serious complications from the virus, when there aren’t enough vaccines in the world to protect high-risk adults from dying,” said Jennifer B. Nuzzo, an epidemiologist at the Johns Hopkins Center for Health Security.

President Biden has come under increasing pressure to give away some of the country’s supply of vaccines. Some federal officials have also urged the administration to decide soon how much vaccine is needed, lest doses expire or be shipped to states and go unused. The federal government has bought 700 million doses of three federally authorized vaccines to be delivered before the end of July, well beyond what would be needed to cover every American.

White House officials said last week that it intended to make up to 60 million doses of the AstraZeneca vaccine available to other countries, so long as federal regulators deem the doses safe. The vaccine has not yet received clearance from American regulators. But global health groups and public health experts said that commitment was not enough.

Dr. Rupali J. Limaye, a Johns Hopkins University researcher who studies vaccine use and hesitancy, said that the United States should donate excess Pfizer-BioNTech shots — and any surplus from other manufacturers — to India and other countries that have had severe outbreaks and pleaded for help.

“From an ethical perspective, we should not be prioritizing people like them over people in countries like India,” Dr. Limaye said of adolescents.

If the United States holds onto its supply of Pfizer-BioNTech, she said, it should be reserved for adults while health officials grapple with the phase of the vaccination campaign that requires more personalized, local outreach.

“We still need to go over hesitant adults, while simultaneously maybe starting at 14- or 15-year-olds,” Dr. Limaye said. “But the priority should still be adults.”



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