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The Biden administration cleared the way Wednesday for millions of Americans to get COVID-19 booster shots and said it will be ready to distribute vaccines for children ages 5 to 11 once the Food and Drug Administration and the Centers for Disease Control and Prevention sign off on an application from Pfizer and BioNTech.
The FDA said people over 65 and those at high risk from COVID-19 who received the Moderna vaccine at least six months ago are cleared for a booster shot, allowing tens of millions of people to join a similar group of Pfizer recipients who got the green light several weeks ago.
Also, any adult who received the Johnson & Johnson vaccine at least two months ago can get a second shot.
People in jobs that put them at risk of catching the virus are also eligible for Pfizer and Moderna boosters.
“The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease,” acting FDA Commissioner Janet Woodcock said.
Yet regulators added a big twist: People can mix and match by receiving a booster that is different from the version they received months ago.
The FDA did not recommend one brand over another, but the decision to provide flexibility comes after regulators reviewed data that showed recipients of the J&J vaccine that received a Moderna booster saw their antibody levels rise 76-fold after 15 days, versus a four-fold increase after an extra dose of the J&J version.
Roughly 15 million Americans have been vaccinated with the one-shot J&J dose and may want to switch to Moderna or Pfizer.
Looking ahead, White House COVID-19 coordinator Jeff Zients said the administration expects signoff on the Pfizer vaccine for children in the “next couple weeks.”
The vaccines for children use a smaller dose than the ones given to adults. Federal officials said they worked with Pfizer to make sure packages of the childhood vaccines are clearly labeled and provide smaller vials and needles.
Mr. Zients said the government secured enough doses for every child in the age group. About 25,000 pediatric and primary-care doctor sites, tens of thousands of pharmacies and health centers in rural and underprivileged urban areas will be offering the shots to U.S. children, giving the campaign a different look than the adult rollout that featured mass-vaccination sites.
The rollout could begin as soon as the first week of November. Advisers to the FDA are scheduled to discuss Pfizer’s request for emergency approval of its vaccine for ages 5 to 11 on Oct. 26.
If advisers respond positively to the request, FDA approval and recommendations from the CDC could kickstart the rollout within days.
“Should the FDA and CDC authorize the vaccine, we will be ready to get shots in arms,” Mr. Zients said.
The plan will start with a shipment of about 15 million doses nationwide in the first few days following the CDC’s signoff, followed by millions more in each of the following weeks.
Mr. Zients repeatedly defended the decision to roll out a big campaign before the FDA authorizes the shots.
Previously, the White House made a big splash in promoting booster shots for everyone who received a second dose at least eight months ago, only to see the FDA curtail the scope of the rollout to specific populations.
Nearly 11 million people have received boosters, and CNN reported Wednesday that the FDA is exploring whether to advise people as young as 40 to get boosters, though that decision could be weeks away.
“I think we’re actually doing the right thing here [with child vaccines] as we did before, which is to make sure that we are operationally ready,” Mr. Zients said. “We are going to be ready pending the FDA and CDC decision that will be based on science. But we want to make sure the operations are ready to accommodate kids.”
The American Medical Association applauded the administration for thinking ahead.
“Laying this advance groundwork, ensuring supply is available at physician practices, and that a patient’s own physician is available to answer questions, is critical to the continued success of this rollout,” AMA President Gerald E. Harmon said. “We encourage all parents to get their children vaccinated against COVID-19 once vaccines are authorized and recommended for use in this population.”
Younger people have tended to avoid the worst outcomes from COVID-19, but are not guaranteed to have an easy time with the disease. Doctors reported an uptick in child cases as the delta variant took hold and society opened up.
“Fully vaccinated individuals are 10 times less likely to be hospitalized with COVID-19 and have a high degree of protection, including against the delta variant,” a White House fact sheet said. “The consequences of a pediatric COVID-19 case can be serious and potentially last months.”
Only about a third of parents — 34% — of parents said they would get their children ages 5 to 11 vaccinated “right away” once the shots are available, according to a Kaiser Family Foundation poll released at the end of September.
That’s up from 26% in July, however, and the bulk of September interviews were conducted prior to Pfizer announcing positive results from its trial in children 5 to 11.
Another 32% said they would “wait and see” whether to bring forward a child in that age group. About a quarter of parents, 24%, said they would “definitely not” get their kids in the group vaccinated and 7% said they would do it only if required.
Sometimes the decision to vaccinate a child splits families, especially divorced couples with joint custody of their kids.
Leslie Silva, a partner at the Tully Rinckey law firm in Albany, New York, pointed to a court decision out of Brooklyn in 2019 that sided with the pro-vaccine parent during the measles outbreak that year in and around New York City.
“That’s the trend. The overall legal standard is, ‘What is in the best interest of the child?’” she said. “It’s going to be decided on a case-by-case basis but in what we’ve seen so far it looks like the courts are trending toward vaccinating the children.”
She said anti-vaccine parents also might be pressured to drop their opposition in a settlement if states begin to mandate the COVID-19 vaccine for children to go to school or daycare.
“I know California has already done that. I don’t think New York is far behind,” she said.
Eligibility for the shots has been a key factor in the percentage of Americans who are vaccinated for COVID-19, as the nation tries to reach an elusive threshold of immunity that would make the virus a manageable problem.
Only 57% of the U.S. population is fully vaccinated, but the rate rises to two-thirds of Americans when looking at those who are eligible, meaning age 12 or older.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said recent papers show children transmit the virus as readily as adults in the “delta era” so vaccinating them could play a role in reaching sufficient immunity levels to control the virus within households and communities.
“If we can get the overwhelming majority of the 28 million children vaccinated, I think that would play a major role in diminishing the spread of infection in the community,” Dr. Fauci said. “We want to do as best as we can to get those children 5 to 11 vaccinated.”
Panagis Galiatsatos, an assistant professor at Johns Hopkins School of Medicine in Baltimore, said many parents he sees are eager to get their kids vaccinated. While some of the enthusiasm is to protect their kids, most want to make sure their children are less likely to be infected and spread the virus to more vulnerable relatives.
“Much of it is to allow the kids to be with the elderly grandparents,” he told The Washington Times.
Mr. Zients said many families are “eagerly awaiting” the chance to get their children protected but the administration realizes some parents remain leery, so they will rely on trusted voices in communities to promote the vaccines.
U.S. Surgeon General Vivek Murthy said faith leaders will play a key role and consent forms for parents will be in multiple languages. They also will leverage Head Start programs to get the word out.
Dr. Fauci said routine childhood vaccinations for other diseases prevented an estimated 732,000 deaths in children born between 1994 and 2013.
He also said vaccines remain available to the 66 million Americans who are eligible for the shots and haven’t come forward.
“It is not too late, so please, please get vaccinated,” Dr. Fauci said.