WASHINGTON – The Food and Drug Administration plans to expand booster ratings of the coronavirus vaccine on Monday, allowing 12-15 year olds a third dose of the Pfizer BioNTech, according to people familiar with the agency’s deliberations Vaccine.
Regulators are also expected to approve an additional vaccination of the Pfizer vaccine for both adolescents and adults five months after receiving a second dose, instead of the previous six months. Younger immunocompromised children, ages 5-11, may also receive booster injections.
The decision to expand the use of the gunshot would be made as schools reopen after the holidays and governments around the world try to respond to the fast-spreading variant of Omicron. Israel on Thursday approved a fourth dose of vaccine for people with compromised immune systems, and the UK’s National Health Service said its hospitals were building field stations to deal with the surge in coronavirus cases.
Several U.S. states hit their all-time case records for the coronavirus this week, disrupting the lives of millions of Americans. New York Mayor-elect Eric Adams promised to keep the city’s private-sector employee vaccination mandate, and the CDC bluntly warned potential travelers, “Avoid cruises regardless of vaccination status.”
Health officials are trying to encourage more Americans to get a booster vaccination – just over a third of fully vaccinated adults have received one – warning that those who are not vaccinated are at greatest risk of serious illness and death from Omicron.
“Our CDC guideline was very clear that people should get their boost when they are entitled,” said Dr. Rochelle P. Walensky, the director of the CDC, told reporters this week. “That’s both for – because of the diminishing immunity and because we need more protection against Omicron.”
Dr. Walensky said Wednesday that the number of daily cases had increased by about 60 percent over the past week, hospital stays and deaths were still relatively low, suggesting Omicron could be less fatal. You and Dr. Anthony S. Fauci, the senior medical advisor to President Biden, cited international research suggesting the same conclusion.
Studies have shown that while two doses of the Pfizer BioNTech vaccine offered strong protection when the Delta variant flooded the country, Omicron can bypass the defenses of fully vaccinated people, adding to fears about the risks to young people.
More than 70 percent of people aged 12 and over in the US are fully vaccinated, according to the CDC, about a quarter of children between the ages of 5 and 11 have received at least one dose. Children under 5 are still not eligible for vaccination.
The recent surge has resulted in a worrying increase in hospital admissions for children. But initial data suggests that Omicron causes a milder disease in children, much like it does in adults. And hospital officials and doctors said almost all of the children hospitalized with Covid-19 were unvaccinated or partially vaccinated.
Children can tolerate infections with the coronavirus better, but in rare cases they can still get very sick and even die. According to CDC. At least 1.8 million teenagers between the ages of 12 and 15 tested positive for the virus
A series of studies published by the agency on Thursday underlined the importance of vaccinations for children and adolescents. In a July through early December study that examined hundreds of teenagers in Arizona, researchers said two doses of the vaccine reduced the risk of infection by 92 percent.
Two other CDC studies showed that 5 to 11 year olds who received the Pfizer BioNTech vaccine had few reported serious side effects and that pediatric hospitalizations were mainly in children who were not fully vaccinated.
A recent South African study showed that the effectiveness of Pfizer’s vaccine against serious illness and hospitalization was about 70 percent after two doses, especially against Omicron.
Pfizer-BioNTech’s vaccine is the only one of three federally approved coronavirus vaccines 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 mid-next week to consider whether to recommend the changes in the FDA’s booster policy. If the committee is in agreement with the FDA approvals, it is expected that Dr. Walensky immediately approved the revisions.
Dr. Kathryn M. Edwards, vaccine expert and professor of pediatrics at Vanderbilt University School of Medicine, said the FDA’s anticipated decision was justified.
“We have a lot of suggestions and a lot of experience with Omicron that the infection was promoted by humans. Fortunately, we don’t see a lot of serious illnesses, ”she said. “I think if you look at the immune responses, at least in adults, you will find that this booster dose improves your ability to neutralize Omicron.”
Other vaccine experts said the government’s continued focus on 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 into the effectiveness of vaccines, including against Omicron, has shown significant and lasting two-dose protection against serious illness. even in adolescents – the purpose of vaccination, he said.
A booster dose could increase protection for several months, he said, but giving extra vaccinations to young Americans is “focused on the people who are already protected.”
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The Biden administration, he added, should instead pay more attention to reaching out to the unvaccinated, a point he believed was supported by the overwhelming majority of hospitalized children he had seen in Philadelphia who were unvaccinated.
The FDA was hoping to announce its decision to expand boosters for children as early as Thursday, people familiar with the deliberations said, but they agreed to wait until Monday as Dr. Walensky said she wanted to hear recommendations from her agency’s external advisory group on the changes before signing. This group, which has met throughout the pandemic to consider FDA decisions on vaccines, may not meet until Wednesday.
The two agencies share responsibility for setting the country’s vaccine policy and have worked to present a unified front in their booster reviews. However, the FDA was more willing to act without the advice of its external advisory committee, as some senior officials argued that the agency needed to act as quickly as possible in the face of the public health crisis.
Although the FDA has convened its external advisory committee repeatedly this year, it did not seek recommendations from the panel prior to its recent decisions to expand boosters.
Dr. Walensky approved offering Pfizer BioNTech booster syringes to 16- and 17-year-olds this month without convening their agency’s committee of experts. But she doesn’t want to do that for younger adolescents, said people familiar with the government’s considerations.
Some outside experts have argued that by bypassing the outside committees, the CDC and FDA have falsely restricted public discussion of the evidence to justify expanding the use of boosters.
Dr. Offit said a meeting of the FDA committee that was initially skeptical of younger, healthy people needing booster doses to discuss the recent booster decision could provide some transparency on the data reviewed by regulators.
“The American public gets to hear this discussion,” he said.
Federal regulators based their decision, at least in part, on data from Israel that did not reveal serious safety concerns in the thousands of 12-15 year olds who received a third dose of the Pfizer vaccine. There have been no reports of myocarditis, a rare side effect seen mainly in younger men and associated with the Pfizer and Moderna vaccines. The condition involves inflammation of the heart muscle.
The FDA plans to approve a booster dose as early as five months after the second dose of Pfizer, in part because Israeli data suggest the shorter interval is effective, according to those familiar with the government’s deliberations.
Israel launched an early and aggressive booster campaign earlier this year, and Biden government health officials have relied heavily on research by Israeli officials to argue for Americans getting boosters.
Pfizer and BioNTech, their German partner, said their studies showed that a third dose is needed to bring neutralizing antibodies back to levels that are considered highly effective against infections. Dr. Albert Bourla, Pfizer’s chairman of the board, said this month that while two doses could prevent serious Omicron disease, a third will strengthen protection.
Dr. Ugur Sahin, CEO of BioNTech, said three doses might “still provide adequate protection against diseases of any severity” caused by the variant.
Carl Zimmer Reporting contributed.