FDA plans to allow 12- to 15-year-olds to receive pfizer boosters

WASHINGTON: The Food and Drug Administration is planning to broaden eligibility for coronavirus vaccine booster shots, allowing 12- to 15-year-olds to receive third doses of Pfizer-BioNTech’s vaccine, according to people familiar with the agency’s deliberations.
Regulators are also expected to authorize an extra shot of Pfizer’s vaccine for both adolescents and adults five months after receiving a second dose, instead of the current interval of six months. Younger children, ages 5 to 11, with immune deficiencies would be able to receive booster shots as well.
The decision to expand the use of the shots would come just as schools prepare to open after the holiday break and as governments around the world try to respond to the fast-spreading omicron variant. Israel on Thursday approved a fourth dose of vaccine for people with weakened immune systems, and Britain’s National Health Service said its hospitals would erect field wards to help deal with the surge in coronavirus cases.
Several US states hit their all-time case records for coronavirus cases this week, disrupting the lives of millions of Americans. New York Mayor-elect Eric Adams vowed to keep the city’s vaccine mandate for private-sector employees in place, and the CDC issued a blunt warning to potential travelers: “Avoid cruise travel regardless of vaccination status.”
Health officials are trying to encourage more Americans to get a booster shot — just over one-third of fully vaccinated adults have received one — and warn that the unvaccinated face the greatest risk of severe illness and death from omicron.
“Our CDC guidance has been very clear that people should get their boost when they are eligible,” Dr. Rochelle PWalensky, the CDC director, told reporters this week. “That is both for — because of waning immunity and because we need more protection against Omicron.”
Walensky said Wednesday that even as daily case counts had climbed by roughly 60% in the past week, hospitalizations and deaths were still relatively low, a suggestion that omicron might be less lethal. She and Dr. Anthony Fauci, President Joe Biden’s chief medical adviser, cited international research hinting at the same conclusion.
Studies have shown that while two doses of the Pfizer-BioNTech vaccine have provided strong protection as the delta variant swarmed the country, omicron can evade the defenses of fully vaccinated people, heightening fears about the risks for young people.
More than 70% of people 12 and older in the United States are fully vaccinated, according to the CDC. Around one-quarter of children between 5 and 11 have received at least one dose. Children under 5 are still not eligible for a vaccine.
The latest surge has caused a concerning rise in hospitalizations among children. But early data suggests that omicron appears to be causing milder illness for children, similar to findings for adults. And hospital officials and physicians have said that nearly all children hospitalized with Covid-19 were unvaccinated or partially vaccinated.
Children can better withstand coronavirus infections but in rare instances can still become very sick and even die. At least 1.8 million adolescents between 12 and 15 years old have tested positive for the virus, according to the CDC.
A series of studies published Thursday by the agency underscored how important vaccination can be for children and adolescents. In one study spanning July through early December that examined hundreds of adolescents in Arizona, researchers said two doses of the vaccine reduced the risk of infection by 92%.
Two other CDC studies showed that there were few serious side effects reported among 5- to 11-year-olds who had received the Pfizer-BioNTech vaccine and that pediatric hospitalizations occurred mostly among children who had not been fully vaccinated.
A recent South African study showed that the effectiveness of Pfizer’s vaccine against severe illness and hospitalization was about 70% after two doses, against omicron in particular.
Of the three federally authorized coronavirus shots, Pfizer-BioNTech’s is the only vaccine approved for use in people under 18.
The Centers for Disease Control and Prevention’s vaccine advisory committee is planning to meet by the middle of next week to weigh in on whether to recommend the changes in the FDA’s booster policy. If the committee agrees with the FDA’s authorizations, Walensky is expected to promptly endorse the revisions.
Dr. Kathryn M. Edwards, a vaccine expert and professor of pediatrics at Vanderbilt University School of Medicine, said the FDA’s expected decision was justified.
“We’re having a lot of suggestions and a lot of experience with omicron that it’s infecting people that have been boosted. But fortunately, we’re not seeing a lot of severe disease,” she said. “So I think if you look at the immune responses, at least in adults, you’ll see that this booster dose does enhance your neutralization capacity against omicron.”
Other vaccine experts said the administration’s continued attention to offering boosters to younger, healthier people was misguided.
Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s vaccine advisory committee, said research on vaccine effectiveness, including against omicron, had revealed that two doses offer substantial and durable protection against severe disease, including in adolescents — the purpose of vaccination, he said.
A booster dose could increase a person’s protection for several months, he said, but delivering extra shots to young Americans was “focusing on the people who are already protected.”
The Biden administration, he added, should instead direct more attention to reaching the unvaccinated, a point he said was backed up by the overwhelming majority of hospitalized children he had seen in Philadelphia being unvaccinated.

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