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FDA approves COVID-19 vaccine for children ages 5-11

FDA approves COVID-19 vaccine for children ages 5-11

  • November 1, 2021

COVID-19 vaccines are already approved for children ages 12 and older, and vaccinations are now supported by the U.S. Food and Drug Administration (FDA) for younger children ages 5-11.

On October 29, the FDA approved Pfizer-BioNTech’s COVID-19 vaccine for the youngest eligible group still immunized against the disease in the United States. The decision followed the recommendation of the Agency’s Advisory Committee, which concluded, 17 votes to 0, with one abstention that the vaccine is safe and effective in younger children. For these children, the FDA recommends a two-dose regimen at one-third the adult-approved dosage.
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The Centers for Disease Control and Prevention (CDC) will meet next week to determine which specific groups of children in this age group should be vaccinated. After weighing the risks, the agency’s public health experts could, for example, only recommend the injection to children at high risk for severe COVID-19, or another subset of the larger group for which the FDA approved the injection.

FDA committee members also struggled with this issue, as the data presented by Pfizer-BioNTech included weighing the benefits of the vaccine in protecting children from COVID-19 disease against the theoretical risks of side effects, almost all of them Children and adults have been observed in elderly patients. These complications include inflammation of the tissue of the heart known as myocarditis and pericarditis.

Committee members also looked at the fact that according to the data presented by CDC scientists, up to 40% of children aged 5-11 may have already been infected with SARS-CoV-2, and this could be an underestimation. since many younger children who are infected have no symptoms and therefore never see a doctor or seek medical attention. That means they may have some immunity to the virus, though it’s unclear how robust it would be. “I think it is possible that at best you will only need a dose that will be more than enough for you,” said Dr. Michael Kurilla, director of clinical innovation at the National Institutes of Health, who abstained from the vote. Kurilla expressed concern that Pfizer-BioNTech has not provided data detailing what happens to the virus-fighting antibodies that children make after vaccination and whether they decrease like adults do. He was also concerned about vaccinating children who may already have been naturally infected and who don’t need extra protection from an injection.

The U.S. is reviewing data on how safe and effective each of the three approved or approved COVID-19 vaccines for children is. On October 25, Moderna filed its application with the FDA to extend its approval to children ages 6-11. This was based on data the company provided showing that the vaccine can provide strong protection against COVID-19 disease.

For today’s discussion, Pfizer-BioNTech provided data from two studies involving more than 3,100 children, ages 5-11, who received either two doses of their vaccine or two doses of a placebo. About half have been followed for two months or more, and the other half for less than a month. According to the studies by Pfizer-BioNTech, the two syringes, each given at a third of the adult dose, were 90.7% effective in protecting the children from symptoms of COVID-19. Three children who received the vaccine tested positive for COVID-19, while 16 in the placebo group tested positive seven days after their second dose.

The committee agreed that children with underlying health conditions, including obesity and chronic diseases such as diabetes, would benefit from vaccination. In otherwise healthy children, however, the balance wasn’t as clear – given the relatively high proportion of children who may already be immune to natural infection, as well as the potential risk of myocarditis, Kurilla noted. Heart risk in older adolescents and adults was rare but worrying, especially in young men, and the vaccine label currently includes a warning for this group. However, it is not clear whether the same risk is passed on to younger children. Because of this, the FDA asked Pfizer-BioNTech for additional data on more than 1,500 adolescents, in addition to the original 1,500 the companies originally investigated, allowing the agency to investigate the side effects more closely.

In their analysis, the FDA found that people naturally infected with COVID-19 have an almost 16-fold increased risk of myocarditis compared to uninfected people. Scientists also weighed the risk of multisystem inflammatory syndrome (MIS-C), a rare condition that causes fever, drop in blood pressure, and damage to various organs including the liver. Last year, the CDC recorded more than 5,200 cases of MIS-C and 46 deaths, mostly in children ages 5 to 13.

FDA scientists performed extensive modeling to predict how the benefits and risks would play out, and found that the balance depends heavily on how much virus is circulating. During the spikes of infection, the benefits of protecting children from the disease outweigh the low risks of complications from the vaccine, but in a model that assumed a very low community prevalence of COVID-19, the risk of developing myocarditis was out of the rates estimated that, among older children, negate any potential benefit of the vaccine.

Overall, however, the FDA concluded that the potential longer-term risks of COVID-19 infection, including Long COVID, could tip the balance in favor of vaccination. “To me the question is pretty clear. We don’t want children to die of COVID-19, even though far fewer children than adults are affected by the disease, and we don’t want them to stay in intensive care, ”said Dr. Amanda Cohn, Chief Medical Officer for the National Center for Vaccination and Respiratory Diseases at the CDC.

Ultimately, the role of the FDA committee is to evaluate the safety and effectiveness of the vaccine for a given age group. It is up to the CDC to decide exactly which children in this age group should be vaccinated. This led most of the committee members to vote to ensure that children who need the vaccine and could benefit from it can be vaccinated if their parents so wish. “I voted ‘yes’ because I want to make sure that children who really need this vaccine – mostly black and brown children – get the vaccine,” said Dr. James Hildreth, Professor of Internal Medicine at Meharry Medical College. “There are many, many children for whom the vaccine could mean the difference between health and even life. I hope the [CDC’s committee] will prioritize the vaccine in some way to make sure it actually happens.

Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine and professor of immunology at Harvard TH Chan School of Public Health and Brigham and Women’s Hospital, admitted that “it was with a heavy conscience that we voted in favor. I hope this is the beginning of learning more about the use of this vaccine. “

Children and especially younger children are the last group to be vaccinated against COVID-19 after the elderly, adults and adolescents. As more people were vaccinated in the United States, new infections, hospital admissions and deaths from the disease have decreased. But infections and diseases are on the rise in the youngest children, underscoring the need for rapid vaccination. Of the more than 44 million cases of COVID-19 reported since the pandemic began, nearly 9% have occurred in children ages 5-11. In August, 39% of the cases in those under 18 were in 5-11 year olds. Almost 150 children in this age group have died from COVID-19.

Even more worrying, young children become infected with no symptoms and pass the virus on to others. Dr. Anthony Fauci, Senior Medical Advisor to the White House and director of the National Institute of Allergy and Infectious Diseases, said in a recent briefing that “months ago, based on the data with [the] alpha [variant] above all, that children are not so infected. And if they do, they don’t spread the infection in the home. In the Delta Era, children become infected just as easily as adults, and they transmit the infection just as easily as adults. “

This means that as more adults are vaccinated, the virus will find new hosts to infect in order to survive – like young, unvaccinated children who serve as sources of infection for other children (as evidenced by the outbreaks in summer camps last year ), as well as unvaccinated and immunocompromised adults.

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

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