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

WASHINGTON: The Food and Drug Administration is planning to broaden eligibility for coronavirus vaccine booster shots, allowing 12 to 15-year-olds to receive a third dose of Pfizer-BioNtech’s vaccine, the agency deliberates. According to people familiar with
Regulators are also expected to authorize an additional shot of Pfizer’s vaccine for both teens and adults five months after receiving the second dose, instead of the current six-month interval. Younger children between the ages of 5 and 11 who have immune deficiencies will also be able to receive booster shots.
The decision to expand the use of shots will come as schools prepare to open after the holiday break and governments around the world try to respond to the fast-spreading Omicron version. Israel on Thursday approved a fourth dose of the vaccine for people with weakened immune systems, and Britain’s National Health Service said its hospitals would create field wards to help deal with the rise in coronavirus cases.
Several US states this week hit their all-time record for coronavirus cases, disrupting the lives of millions of Americans. New York mayor-elect Eric Adams vowed to uphold the city’s vaccine mandate for private sector workers, 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 — more than a third of fully vaccinated adults have received one — and have warned that non-vaccination can lead to serious illness and disease. Omicron has the greatest risk of death.
“Our CDC guidance is very clear that people should get the boost they deserve,” CDC Director Dr. Rochelle Pivalensky told reporters this week. “It’s for both — because of decreased immunity and because we need more protection against omicrons.”
Valensky said on Wednesday that even though the number of daily cases had increased by about 60% in the past week, hospitalizations and deaths were still relatively low, a suggestion that Omicron may be less lethal. He and Dr. Anthony Fauci, chief medical adviser to President Joe Biden, cited international research to draw the same conclusion.
Studies have shown that two doses of the Pfizer-BioNTech vaccine provided strong protection. The suspicion increases.
According to the CDC, more than 70% of people 12 years of age and older in the United States are fully vaccinated. About one-quarter of children between 5 and 11 have received at least one dose. Children under the age of 5 are still not eligible for the vaccine.
The latest surge has led to an increase in hospitalizations among children. But early data suggests that Omicron is causing minor illness for children, similar to findings for adults. And hospital officials and doctors have said that almost all children hospitalized with Covid-19 were unvaccinated or partially vaccinated.
Children may cope better with coronavirus infection but can still become very ill and die in rare cases. According to the CDC, at least 1.8 million teens between the ages of 12 and 15 have tested positive for the virus.
A series of studies published Thursday by the agency underscored how important vaccination can be for children and teens. In a study conducted from July to early December that examined hundreds of teens in Arizona, researchers said that two doses of the vaccine reduced the risk of infection by 92%.
Two other CDC studies showed that few serious side effects were reported in children ages 5 to 11 who received the Pfizer-BioNTech vaccine and that pediatric hospitalizations occurred mostly in children who were completely was not vaccinated.
A recent South African study showed that the effectiveness of Pfizer’s vaccine against serious illness and hospitalization was about 70% after two doses, specifically against Omicron.
Of the three federally authorized coronavirus shots, Pfizer-BioEntech is the only vaccine approved for use in people under the age of 18.
The Centers for Disease Control and Prevention’s vaccine advisory committee plans to meet by the middle of next week to recommend changes to the FDA’s booster policy. If the committee agrees with the FDA’s authorizations, Valensky is expected to support the amendments immediately.
Dr. Catherine M. Edwards, a vaccine specialist and professor of pediatrics at Vanderbilt University School of Medicine, said the FDA’s expected decision was appropriate.
“We have a lot of suggestions and a lot of experience with Omicron that it is infecting people who have been elevated. But luckily, we are not seeing very serious disease,” she said. that if you look at the immune responses, at least in adults, you’ll see that this booster dose increases your neutralization ability against omicrons.”
Other vaccine experts said the administration’s continued focus on giving boosters to young, healthy people was a distraction.
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 that research on vaccine effectiveness against Omicron has shown that two doses provide adequate and durable protection against serious disease, The purpose of vaccination – including adolescents, he said.
He added that booster doses can increase a person’s protection for several months, but giving additional shots to young Americans “is to focus on those who are already protected.”
He said the Biden administration should instead focus more on reaching unvaccinated people, a point he said was supported by the overwhelming majority of hospitalized children he saw in Philadelphia without vaccinations.

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