FDA panel recommends Pfizer vaccine for children ages 5 to 11

A Food and Drug Administration (FDA) panel of experts voted to recommend authorizing the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11.

In a live broadcast session, the Vaccines and Related Biological Products Advisory Committee met on Tuesday (Oct. 26) to discuss safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine in young children.

After a day of discussions on the risks and benefits of making the vaccine available for young kids, the panel overwhelmingly voted to recommend an emergency use authorization for this age group; 17 out of 18 experts on the panel voted yes and one abstained from voting.

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Children ages 5 to 11 account for more than 1.9 million reported cases of COVID-19 in the U.S. and more than 8,300 related hospitalizations, according to presentations from the meeting. A serious but rare complication of COVID-19 infection known as multisystem inflammatory syndrome (MIS-C), in which various parts of the body such as the heart and lungs become inflamed, occurs more in this age group than any other.

Pfizer presented results from a clinical trial that tested the safety and efficacy of the vaccine in more than 2,200 children ages 5 to 11 who were given a lower dose (10 µg, 21 days apart) compared with the adult dose (30 µg, 21 days apart). The FDA also presented results from its own review of the data.

The data suggested that the vaccine was 90.7% effective in preventing symptomatic COVID-19 starting a week after the second dose among children ages 5 to 11; the vaccine was safe and well-tolerated, with most side effects similar to those observed in older age groups. The most common side effects were pain at the injection site, fatigue and headache; some children also had a swelling of their lymph nodes. No serious adverse reactions related to the vaccine were reported. 

In their risk-benefit discussions, the panel mainly focused on the risk of children developing myocarditis (inflammation of heart muscle) or pericarditis (inflammation of outer lining of the heart), a rare side effect that has been reported in a very small proportion of people vaccinated with either of the two mRNA vaccines, made by Pfizer-BioNTech and Moderna.

None of the children in the trial developed either condition, but the trial size was small and it's possible that some cases may appear once a larger proportion of this age group is vaccinated. 

Modeling data suggests that at the current rates of infection in the U.S., the benefits of vaccinating this age group clearly outweigh the risks, namely of developing those heart conditions and/or being hospitalized from them, Dr. Hong Yang, a scientist at the FDA said. If the rates of COVID-19 greatly decline, the models show the benefit is less obvious; but benefits may still outweigh risks as those hospitalized with myocarditis after vaccination typically fare better than those hospitalized by COVID-19, according to the presentation.

"I think that the decision that we came to is exactly the right one," Dr. Jay Portnoy, an allergist and immunologist who works at a children's hospital in Kansas City, Missouri, said at the meeting. Portnoy noted that the hospital where he works has been full for the last month or so with critically ill children, many of them in the intensive care unit with COVID-19 infections.

"I'm looking forward to being able to actually do something to prevent that," he said. "I am looking forward to seeing my patients tomorrow in the clinic because they've been terrified that their children are going to get COVID. Now I have some really good news for them that they can look forward to."

If the FDA follows the panel's recommendation and authorizes the vaccine, as it will likely do, the discussion then goes to the Centers for Disease Control and Prevention (CDC). The CDC's Advisory Committee on Immunization Practices (ACIP) meets on Nov. 2 and Nov. 3 to discuss pediatric approval of the vaccine; if this panel also recommends authorizing the vaccine for children ages 5 to 11 and the CDC endorses it, the vaccine may become available as soon as early November. (The Pfizer-BioNTech vaccine is only currently authorized for people ages 12 years and up.)

"COVID-19 now is a vaccine-preventable disease from my perspective and COVID is also the 8th highest killer of kids in this age group over the past year," said Dr. Amanda Cohn, the Chief Medical Officer of the National Center for Immunizations and Respiratory Diseases and the Executive Secretary of the ACIP. Vaccinating this age group will prevent death, ICU admissions and significant long-term adverse events that can occur in children who were infected, she said.

"We will monitor myocarditis very carefully," she added, while noting that there have been no deaths from myocarditis and nearly all of those cases have completely recovered just weeks after onset. "I think this is an age group that deserves and should have the same opportunity to be vaccinated as every other age."

Originally published on Live Science.