FDA Panel Endorses Pfizer COVID-19 Vaccine for Kids 5-11

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On Tuesday, an advisory committee to the Food and Drug Administration overwhelmingly voted in favor of recommending the use of the Pfizer-BioNTech COVID-19 vaccine for children ages five to 11.

FDA Panel Endorses Pfizer COVID-19 Vaccine for Kids 5-11
© Marko Geber – Getty Images An advisory committee to the FDA voted in favor of recommending the Pfizer COVID-19 vaccine for kids ages five to 11. Here’s what health experts say about safety and anticipated vaccine roll-out.

If the vaccine is granted an emergency use authorization (EUA) by the FDA—which is expected—COVID-19 vaccines could be available to children aged five and up as early as next week, says Thomas Russo, M.D., professor and chief of infectious disease at the University at Buffalo in New York.

The FDA advisory panel recommended that children in this age group be given one-third the dosage of those who are 12 and older with two shots, given three weeks apart. The FDA is expected to make an official decision on the recommendation within days. If the COVID-19 vaccine is authorized for children aged five to 11, only kids four and younger will be ineligible to get vaccinated in the U.S. against COVID-19—a big win for families.

Once the vaccine gets the official thumbs up from the FDA, the data will be sent to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), which will need to decide who qualifies for the vaccine and how it should be given. (The ACIP plans to meet on Nov. 2 and 3 to discuss this.) Finally, CDC director Rochelle Walensky, M.D., will need to sign off on the recommendations. Only then will parents be able to vaccinate their five- to 11-year-olds.

“This is going to be extraordinarily helpful, and will no doubt be a relief for many parents,” Dr. Russo says. “Some families will finally be able to be fully vaccinated.”

Currently, children make up 25.1% of weekly reported COVID-19 cases, despite making up 22.2% of the U.S. population, according to the American Academy of Pediatrics (AAP). Last week, almost 118,000 new child COVID cases were diagnosed, per AAP data. There has been a 419% increase in COVID-19 cases in children in the U.S. in August and September of this year, compared to June and July.

Here’s what you need to know about the Pfizer-BioNTech COVID-19 vaccine for children, and where things stand so far.

What is the efficacy of the Pfizer-BioNTech vaccine in children ages five to 11?

The data submitted for the Pfizer-BioNTech vaccine analyzed information from about 2,250 study participants, ages five to 11. The data shows that 1,518 received the vaccine and 750 who got a placebo. The children who received the vaccine were given a 10 microgram dose of the mRNA vaccine, and were vaccinated again three weeks later.

The researchers found that the vaccine was 90.7% effective at preventing a COVID-19 infection. There were also no cases of severe COVID-19 reported and no study participants developed multi-system inflammatory syndrome (MIS-C), a rare inflammatory condition tied to COVID-19.

Is it safe to vaccinate kids ages 5–11 for COVID-19?

While plenty of parents are excited to get their kids vaccinated against COVID-19, research has shown that a solid portion are hesitant to give the shot to their kids.

A KFF Vaccine Monitor report published in late September found that 34% of parents of children ages five to 11 will get their children vaccinated “right away” once it’s available. Another 32% plan to “wait and see,” while 24% say that they will “definitely not” have their children get the vaccine. The final 7% said they would get their children vaccinated against the virus “only if required.”

It “will take a bit of time” to see drops in COVID-19 cases once the vaccine becomes available for children in this age group, Dr. Russo says. “Even if we vaccinate every single child, there’s going to be a lag because there needs to be two shots,” he says. However, Dr. Russo points out that this group of children may be protected in time for the holidays and will head back to school with an added layer of protection from COVID-19.

“We’re not going to see an immediate impact in cases, but hopefully cases will be somewhat muted as we move indoors and into cooler weather,” Dr. Russo says.

Overall, though, having more people in the U.S. be eligible to be vaccinated “will increase the overall level of immunity in the population,” says infectious disease expert Amesh A. Adalja, M.D., a senior scholar at the Johns Hopkins Center for Health Security. As a result, he says, COVID-19 cases will continue to drop.

This can be location-specific, though. “Vermont, which has a very high vaccination rate, is going to be different from Utah, which has one of the worst in the country,” Dr. Russo says.

Are there any concerns with giving the vaccine to kids in this age group?

There have been some concerns raised over the risk-benefit ratio of vaccinating children, who are typically low risk for serious complications from COVID-19. People are specifically focused on the risk of myocarditis, an inflammation of the muscles of the heart—a rare complication of the COVID-19 vaccine that has shown up in some older populations. The data submitted for the Pfizer-BioNTech vaccine for five to 11-year-olds did not observe any cases of the condition either during the vaccination period or during a three-month follow-up. However, Dr. Russo says, that doesn’t mean it won’t show up as more children get the shot.

Still, “myocarditis does not appear to be something that is a major risk in this group,” Dr. Adalja says. The risk of myocarditis is also “much greater” when someone actually contracts COVID-19, Dr. Russo points out.

Overall, the risk of myocarditis is “outweighed by the benefit of the vaccine, especially with prevalence of infection as high as it is,” Dr. Adalja says. The vaccine can also help protect children from long haul COVID symptoms that doctors are still learning more about, Dr. Russo says. “Long COVID can be quite disabling,” he says. “I’ve been extraordinarily concerned about long-term consequences to the brain, heart, lungs, and other organs.”

Will there be Moderna and Johnson & Johnson vaccines for kids?

Moderna shared interim data from its COVID-19 vaccine trial in six- to 11-year-olds that found the vaccine delivered a “robust” antibody response and “favorable” safety profile. However, Moderna has not yet submitted its data to the FDA for an emergency use authorization. Johnson & Johnson is also still investigating its COVID-19 vaccine in kids.

But the thumbs up from the FDA’s advisory committee for the Pfizer-BioNTech vaccine doesn’t necessarily mean that the same will happen for Moderna and Johnson & Johnson, Dr. Russo says, noting that the data is all viewed separately.

How will the vaccines be rolled out, and how soon?

The Biden Administration announced last week that it has already taken steps to try to ensure the vaccine is readily available to families who want it as soon as possible. That includes having enough doses to vaccinate 28 million children and working with doctor’s offices, hospitals, pharmacies, community health centers, and schools to make the vaccine as available as possible. More than 25,000 pediatric and primary care provider sites will provide vaccinations for children, the administration says, along with tens of thousands of other provider locations like pharmacies and children’s hospitals.

Dr. Russo expects that the CDC will “act quickly” after the Pfizer-BioNTech vaccine is granted an emergency use authorization from the FDA, noting that Dr. Walensky will likely make a decision “within 24 hours.”

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