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


WASHINGTON: The Food and Drug Administration plans to expand eligibility for coronavirus vaccine booster shots, allowing 12- to 15-year-olds to receive a third dose of Pfizer-BioNTech’s vaccine, according to people familiar with the deliberations of the agency.
Regulators should also allow an additional shot of Pfizer’s vaccine for teens and adults five months after receiving a second dose, instead of the current six-month interval. Younger children, ages 5 to 11, with immune deficiencies could also receive booster shots.
The decision to expand the use of the injections would come as schools prepare to open after the holidays and governments around the world try to respond to the fast-spreading omicron variant. Israel on Thursday approved a fourth dose of a vaccine for people with weakened immune systems, and Britain’s National Health Service said its hospitals would erect field wards to help deal with rising coronavirus cases .
Several U.S. states hit record highs for coronavirus cases this week, disrupting the lives of millions of Americans. New York City Mayor-elect Eric Adams has pledged to keep the city’s vaccination mandate in place for private sector employees, and the CDC has issued a blunt warning to would-be travelers: “Avoid cruise travel regardless of vaccination status.
Health officials are trying to encourage more Americans to get vaccinated – just over a third of fully vaccinated adults have received one – and warn that the unvaccinated are at the greatest risk of serious illness and death. death by omicron.
“Our CDC guidelines have been very clear that people should get their boost when they’re eligible,” CDC director Dr. Rochelle PWalensky told reporters this week. “It’s both for – because of the drop in immunity and because we need more protection against Omicron.”
Walensky said Wednesday that while daily case counts have increased by about 60% over the past week, hospitalizations and deaths are still relatively low, suggesting omicron may be less lethal. She and Dr. Anthony Fauci, President Joe Biden’s chief medical adviser, cited international research alluding to the same conclusion.
Studies have shown that while two doses of the Pfizer-BioNTech vaccine provided strong protection as the delta variant invaded the country, omicron may evade the defenses of fully vaccinated people, increasing 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. About a quarter of children between the ages of 5 and 11 received at least one dose. Children under 5 are still not eligible for a vaccine.
The latest surge has caused a worrying increase in hospitalizations among children. But early data suggests that omicron appears to cause milder disease in children, similar to findings in adults. And hospital officials and doctors said almost all children hospitalized with Covid-19 were unvaccinated or partially vaccinated.
Children can resist coronavirus infections better, but in rare cases they can still get very sick and even die. At least 1.8 million teenagers between the ages of 12 and 15 have tested positive for the virus, according to the CDC.
A series of studies released Thursday by the agency highlighted how important vaccination can be for children and adolescents. In a study spanning July through early December that looked at hundreds of teenagers 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 in children 5 to 11 years old who received the Pfizer-BioNTech vaccine and that pediatric hospitalizations occurred primarily in children who had no not been fully vaccinated.
A recent South African study showed that the effectiveness of Pfizer’s vaccine against serious illness and hospitalization was around 70% after two doses, against omicron in particular.
Of the three federally authorized coronavirus injections, Pfizer-BioNTech is the only vaccine approved for use in people under 18.
The Centers for Disease Control and Prevention’s Vaccine Advisory Committee plans to meet by the middle of next week to consider whether to recommend changes to the FDA’s recall policy. If the committee agrees with the FDA clearances, Walensky should quickly approve 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 have lots of suggestions and lots of experience with omicron infecting people who have been boosted. But luckily we don’t see a lot of serious disease,” she said. “So I think if you look at the immune responses, at least in adults, you’ll see that this booster dose improves your ability to neutralization against the omicron.”
Other vaccine experts have said the administration’s continued focus on offering boosters to younger, healthier people is 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 into the effectiveness of vaccines, including against omicron, had found that two doses provided substantial and long-lasting protection against serious disease, including in adolescents — the goal of vaccination, he said.
A booster dose could boost a person’s protection for several months, he said, but providing additional shots to younger Americans “focused on people who were already protected.”
The Biden administration, he added, should instead pay more attention to reaching the unvaccinated, a point he said was confirmed by the fact that the overwhelming majority of hospitalized children he had seen in Philadelphia were not vaccinated.


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