FDA Committee Recommends COVID-19 Vaccine for Children 5-11 Years Old

Children aged 5-11 years old can get COVID-19 shots.

The COVID-19 vaccine, made by Pfizer BioNTech, was recommended to the panel. It is currently available in 17 states. One abstention. Two-dose treatment was suggested by the committee at one-third the dose approved for adults.

The FDA now takes the committee’s advice into consideration before making a final recommendation. If the agency recommends vaccination, then the Centers for Disease Control and Prevention(CDC) will determine which age group should be vaccinated. (For example, after weighing the benefits of risks, the agency’s public health experts could recommend only children at high risk of severe COVID-19 get the shot.)
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The FDA committee had to wrestle with this question as well. Pfizer BioNTech presented data that weighed the benefits of the vaccine for protecting children from COVID-19, and the potential side effects. Nearly all of these have been seen in adults, older children, and even in young children. These side effects include inflammation of heart tissue (myocarditis) and pericarditis.

The committee members also grappled with the fact that, according to data presented by CDC scientists, up to 40% of children aged 5 to 11 may have already been infected with SARS-CoV-2, and that may be an under estimate, since many younger children who are infected don’t experience symptoms and therefore never go to the doctor or get medical care. That means they might have some immunity against the virus, although it’s unclear how robust it would be. “I think it’s possible they likely only need one dose at best, which is going to be more than sufficient for them,” said Dr. Michael Kurilla, director of the division of clinical innovation at the National Institutes of Health, who abstained from the vote. Kurilla was concerned that Pfizer BioNTech didn’t provide information about the effects of vaccines on children, or whether they wane like in adults. It was also a concern that children might be already infected, and would not benefit from additional vaccines.

The U.S. currently examines data to determine how safe and effective each COVID-19-approved vaccine is for children. Moderna applied to FDA on October 25 to extend its FDA authorization to children aged 6 to 11. This was done based upon data provided by Moderna that showed the vaccine could provide high protection against COVID-19.

For today’s discussion, Pfizer-BioNTech provided data from two studies involving more than 3,100 children ages 5 to 11 who received either two doses of their vaccine or two doses of a placebo. Half of the children were followed for at least two months, while half were monitored for less than a month. According to Pfizer-BioNTech’s studies, the two shots, each given at one-third of the dosage for adults, were 90.7% efficacious in protecting the children from getting symptoms of COVID-19. One-third of the children who received the vaccine were positive for COVID-19. 16 children in the placebo cohort tested positive 7 days later.

It was agreed by the committee that vaccinations would benefit children who have underlying conditions like obesity or chronic illnesses such as diabetes. But for otherwise healthy children, the balance wasn’t as clear—given, as Kurilla noted, the relatively high proportion of children who might already have immunity from natural infection, as well as the potential risk of myocarditis. In older adolescents and adults, the heart risk was rare but concerning, especially among young males, and the vaccine’s label currently contains a warning for this group. But it’s not clear if the same risk translates to younger children. That’s why the FDA asked Pfizer-BioNTech to provide additional data on more than 1,500 youngsters, in addition to the original 1,500 that the companies originally studied, which allowed the agency to delve more deeply into the side effects.

FDA found that myocarditis risk for people naturally infected by COVID-19 is nearly 16 times higher than those not infected. Multisystem Inflammatory Disorder (MIS)-C, a rare disorder that can cause fever, blood pressure loss and organ damage such as the liver, was also taken into consideration by scientists. The CDC has recorded 46 deaths and more than 5200 cases in the last year of MISC, mostly among children aged between 5 and 13 years.

Scientists at FDA did extensive modeling in order to forecast the potential benefits and hazards. The balance of the risk and benefit was strongly dependent on the virus’s circulating levels. The benefits of the vaccine protecting children against the disease are greater than the risks. However, one model that assumed a very low level of COVID-19 infection in the community found that the potential risk of myocarditis from vaccine exposure was negligible. This model used rates from older children to estimate the benefit.

However, the FDA did conclude that vaccines may be more effective than ever because of the long-term risk of COVID-19 infections. “To me, the question is pretty clear. We don’t want children dying of COVID-19 even if there are far fewer children than adults affected by the disease, and we don’t want them in the ICU,” said Dr. Amanda Cohn, chief medical officer at the National Center for Immunizations and Respiratory Diseases at the CDC.

Ultimately, the FDA committee’s role is to evaluate the safety and efficacy of the vaccine for a specific age group. It’s up to the CDC to decide exactly which children in that age range should get vaccinated. This influenced most members of the committee to vote for the vaccine, which ensures that all children can be vaccinated. “I voted ‘yes’ because I want to make sure that children who really need this vaccine—mainly Black and brown children—get the vaccine,” said Dr. James Hildreth, professor of internal medicine at Meharry Medical College. “There are lots and lots of children for whom the vaccine could be the difference between health and even life. “I hope you will [CDC’s committee] will prioritize the vaccine in some way to make sure that actually happens.”

Dr. Eric Rubin, editor in chief of the New England Journal of Medicine and professor of immunology at the Harvard T. H. Chan School of Public Health and Brigham and Women’s Hospital, admitted that “we decided to vote for it with a heavy conscience. I’m hoping this is the start of learning more about how to deploy this vaccine.”

After the adults, adolescents, the elderly and children, the youngest and most vulnerable group of people to get vaccinated for COVID-19 are children and young children. With more Americans being vaccinated against COVID-19, the incidence of the disease has declined and so have hospitalizations, deaths, and new cases. However, infections and diseases are increasing among children under five years old. This highlights the importance of vaccinating them as soon as possible. Nearly 9% of the 44 million COVID-19 cases reported in the wake of the pandemic have been among children between 5 and 11 years old. As of August, 39% were under-age cases. Nearly 150 children under the age of 18 died from COVID-19.

Young children might be spreading the virus from their parents to other people, even if they don’t have symptoms. Dr. Anthony Fauci, chief medical advisor to the White House and director of the National Institute of Allergy and Infectious Diseases, said at a recent briefing that “months ago, it was felt, based on the data with [the] Alpha [variant]Fortunately, children are not as likely to become infected. And if they do, they don’t spread the infection in the home setting. In the era of Delta, children get infected as readily as adults do, and they transmit the infection as readily as adults do.”

That means that as more adults are vaccinated, the virus is finding new hosts to infect to survive—such as young, unvaccinated kids who are serving as sources of infection to other children (as evidenced by the outbreaks among summer camps last year), as well as unvaccinated and immunocompromised adults.

“The reality is that at one point we thought if we vaccinated enough people, then the virus would go away,” said Jeannette Lee, professor of biostatistics at the University of Arkansas. “But it’s not going away, so we have to find a way to live with it. Vaccines give us a way to do that.”


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