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

WASHINGTON – The Food and Drug Administration plans to expand eligibility for booster shots of the coronavirus vaccine on Monday, allowing 12 to 15 year olds to receive third doses of Pfizer-BioNTech’s vaccine, according to people familiar with the deliberations of the agency.

Regulators should also allow an additional injection of Pfizer vaccine for adolescents and adults five months after receiving a second dose, instead of the current six-month interval. Young children, aged 5 to 11, with immune deficiencies may also be given booster shots.

The decision to expand the use of clichés would come as schools prepare to open after the holidays and governments around the world try to respond to the rapidly spreading Omicron variant. 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 will set up field services to help deal with the surge in coronavirus cases.

Several US states hit their all-time high 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 immunization mandate for private sector employees in place, and the CDC has issued a blunt warning to potential travelers: “Avoid domestic travel. cruise, regardless of vaccination status. “

Health officials are trying to encourage more Americans to receive a booster – just over a third of fully vaccinated adults have received one – and warn that the unvaccinated face the greatest risk of serious illness and deaths from Omicron.

“Our advice to the CDC has been very clear that people should be given a boost when they are eligible,” CDC director Dr. Rochelle P. Walensky told reporters. “It’s both for – because of the declining immunity and because we need more protection from Omicron.”

Dr Walensky said on Wednesday that even though the number of daily cases had increased by about 60% over the past week, hospitalizations and deaths were still relatively low, suggesting that Omicron could be less deadly. She and Dr.Anthony S. Fauci, chief medical adviser to President Biden, cited international research hinting at 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 can evade the defenses of fully vaccinated people, increasing fears about the risks to young people.

Over 70 percent of people aged 12 and over in the United States 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 a vaccine.

The latest wave has caused a worrying increase in hospitalizations among children. But early data suggests that Omicron appears to cause milder disease in children, similar to results in adults. And hospital officials and doctors said almost all children hospitalized with Covid-19 were unvaccinated or partially vaccinated.

Children may resist coronavirus infections better, but in rare cases they can still get very sick and even die. At least 1.8 million adolescents between the ages of 12 and 15 have tested positive for the virus, According to the CDC

A series of studies released by the agency on Thursday highlighted how important vaccination can be for children and adolescents. In a study covering July through early December that examined hundreds of teens 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 mostly occurred in children who did not. had 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.

Pfizer-BioNTech’s vaccine is the only one of three coronavirus vaccines approved by the federal government to be 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 decide whether to recommend changes to the FDA’s recall policy. If the committee agrees with the FDA clearances, Dr. 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 a lot of suggestions and a lot of experience with Omicron that it infects people who have been boosted. But luckily we don’t see a lot of serious illnesses, ”she said. “So I think if you look at the immune responses, at least in adults, you will see that this booster dose improves your ability to neutralize against Omicron. “

Other vaccine experts have said the administration’s continued focus on offering boosters to younger, healthier people was wrong.

Dr Paul Offit, director of the Vaccine Education Center at the 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 substantial protection and lasting two doses against serious illness, including in adolescents – the aim of vaccination, he said.

A booster dose could increase protection for several months, he said, but providing additional injections to young Americans “focused on those already protected.”

The Biden administration, he added, should instead pay more attention to reaching the unvaccinated, a point he said was supported by the overwhelming majority of hospitalized children he had seen in Philadelphia not being vaccinated.

The FDA had hoped to announce its decision to expand recalls for children as early as Thursday, people familiar with the deliberations said, but agreed to wait until Monday because Dr Walensky said it wanted to hear the recalls. recommendations from his agency’s external advisory group before signing. about the changes. This group, which has met throughout the pandemic to review FDA vaccine decisions, may not meet until Wednesday.

The two agencies share responsibility for setting the country’s immunization policy and have sought to present a unified front in their reviews of booster injections. But the FDA has been more willing to act without advice from its external advisory board, with some senior officials arguing that the agency must respond as quickly as possible to the public health crisis.

Although the FDA has convened its external advisory committee several times this year, it did not ask the panel for recommendations until its most recent decisions to expand boosters.

Dr Walensky this month approved offering Pfizer-BioNTech reminders to 16 and 17 year olds without convening his agency’s expert committee. But she was unwilling to do it for younger teens, people familiar with the government’s deliberations said.

Some outside experts argued that by bypassing external committees, the CDC and the FDA were wrongly limiting public debate on the evidence to justify expanding the use of boosters.

Dr Offit said that a meeting of the FDA committee, which was initially skeptical of younger, healthy people in need of booster doses, to discuss the most recent recall decision, may offer some insight. some transparency on the data examined by the regulators.

“The American public can hear this discussion,” he said.

Federal regulators based their decision at least in part on data from Israel that showed no serious safety concerns in thousands of children aged 12 to 15 who received a third dose of the Pfizer vaccine. There have been no reports of myocarditis, a rare side effect seen primarily in younger men that has been linked to Pfizer and Moderna vaccines. The condition involves inflammation of the heart muscle.

The FDA wants to allow a booster as soon as five months after the second dose of Pfizer in part because Israeli data suggests the shorter interval is effective, according to people familiar with the government’s deliberations.

Israel has launched an early and aggressive recall campaign this year, and health officials in the Biden administration have relied heavily on research by Israeli officials to advocate for Americans to get recalls.

Pfizer and BioNTech, its German partner, both said their studies showed that a third dose was needed to bring the neutralizing antibodies to a level considered highly effective against the infection. Dr Albert Bourla, chief executive of Pfizer, said this month that while two doses can still prevent serious Omicron disease, a third strengthens protection.

Dr Ugur Sahin, CEO of BioNTech, said three doses “could still provide a sufficient level of protection against diseases of any severity” caused by the variant.

Carl Zimmer contributed reports.