a Small dose of Pfizer-BioNtech’s COVID-19 vaccine The Food and Drug Administration advisory committee approved its first regulatory hurdle Tuesday for use in young children, after voting to recommend for emergency use authorization for ages 5 to 11.
The 17-0 vote, with one abstention, will now go to the FDA, which is expected to make a final decision in the coming days. If authorized, the move would make almost the entire US population eligible for a Covid shot. Only children 4 years of age and below will be ineligible.
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Despite the vote in favor, deciding whether the benefits of vaccination for young children outweigh the potential risks fall heavily on advisers.
“I think it’s more difficult than we expected it to be,” said committee member Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine. “The data show that the vaccine works and it is very safe … we are concerned about a side effect that we can’t measure yet,” he said, referring to a heart condition called myocarditis.
There was also the issue of whether children were at all in need of vaccination given their generally low risk of covid.
“It seems to me that in some ways, we’re vaccinating children to protect adults, and it should be the other way around,” said committee member Dr. James Hildreth, president and CEO of Meharry Medical College in Tennessee. “I believe the most at-risk children need to be vaccinated. But vaccinating all children … it seems a bit overkill to me.”
For Dr. Amanda Cohn, chief medical officer of the Centers for Disease Control and Prevention, the benefits of vaccination were very clear.
“When I look at this question, it is very clear to me that the benefits outweigh the risks, when I hear about babies being placed in the ICU with long-term outcomes after their covid , and the children are dying,” she said. “We routinely vaccinate against some vaccine-preventable diseases, which have very few deaths and hospitalizations and ICU admissions.”
Dr. Paul Offit, a vaccine researcher and committee member at Children’s Hospital of Philadelphia, acknowledged the difficulty of the decision.
“It’s always nerve-wracking, I guess, when you’re asked to make decisions for millions of kids based on the education of just a few thousand kids,” he said. “The question is, when do you know enough? And I think we know for sure that there are many children between the ages of 5 and 11 who are vulnerable to this disease who can become very ill and be hospitalized. may or may die from it.”
Ovata Fuller, associate professor of microbiology and immunology at the University of Michigan, supported the vote.
“The benefits of this option far outweigh the known risks,” she said. “We can’t for sure predict all the risks ahead, but we know we have systems in place that can help us do that. So, I think we have to take a step and say That we want to provide this option to those who can. Help children as well as others in this pandemic.”
Cohn of the CDC, as well as director of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marx emphasized that safety monitoring for rare side effects, including myocarditis, will continue after emergency use authorization.
In fact, it was through such safety monitoring that myocarditis was first identified as a rare side effect of vaccination, committee member Dr. Steven Pergum, an infectious disease specialist with the Seattle Cancer Care Alliance, said during the discussion. mentioned.
covid in children
The vaccine for children ages 5 to 11 is a smaller dose than the dose given to children 12 and older — 10 micrograms of mRNA versus 30 micrograms. As in adults, the complete vaccination series consists of two doses spaced three weeks apart. Children’s supplements will come in vials with an orange cap and an orange label. Doses for adults and adolescents come in vials with a purple cap and a purple label.
Although children are less likely to develop serious illness from COVID, more than 1.9 million children aged 5 to 11 have tested positive for the coronavirus during the pandemic, and more than 8,400 were hospitalized A medical officer, Dr. Fiona Havers said. with CDC. He said that when children are hospitalized with Covid, they are more likely to be admitted to the intensive care unit and need ventilators than children hospitalized with the flu.
He said that 94 children have died of Covid, making it the eighth leading cause of death in this age group.
Children who test positive for Covid are also given A. is at risk for Rare inflammatory condition known as MIS-C. is called, or multisystem inflammatory syndrome in children. As of October 4, 5,217 children of all ages have developed MIS-C, and 46 have died, he said, adding that the condition was most common in children ages 5 to 11.
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Although most cases of the virus in children are mild, children can still spread it to others, including family members and school people, Havers said. Children are at least as likely to be infected with the virus as adults, but those infections are less likely to be reported, she said. In other words, children are likely to miss positive cases.
It is not clear what effect the vaccine will have on transmission, and Pfizer’s trial in children was not designed for the study, Dr William Gruber, a scientist at Pfizer, said during the meeting. However, he pointed to “real-world evidence” that vaccination affects transmission in adults, adding that “it is reasonable to expect that there will be some reduction in transmission to children”.
It’s also unclear whether young children will eventually need one. booster dose. Committee member Dr. Michael Kurilla, an infectious disease specialist at the National Institutes of Health, pointed out that Pfizer had limited follow-up data, and asked whether there was any reason to think that antibody levels in children would not be as low as whether has been seen in adults.
“What’s the expectation that these kids will need a booster at six months?” He asked.
Gruber responded that the company would have more information in a six-month follow-up.
In its presentation to the FDA, Pfizer said its vaccine was approx. 91 percent effective On preventing symptomatic disease in children. There were three cases of covid in the vaccine group compared to 16 cases in the placebo group. cases occurred between July and September, when The highly permeable delta variant was dominant, suggesting that the vaccine held up well against it, Gruber said. (He said 14 of the 19 cases were indexed and determined to be delta.)
Side effects Vaccinations included pain in the arm, fever and muscle aches. However, the FDA said that Pfizer’s trial was not sufficient to detect extremely rare side effects, including myocarditis, seen after the second dose, especially in young men and adolescent boys. In the Pfizer trial, more than 1,500 children aged 5 to 11 years received the vaccine (another 750 received a placebo) and there were no cases of myocarditis.
The lack of data on myocarditis was of concern to the committee members. In a presentation to the committee, the CDC’s Covid-19 response team’s Dr. Matthew Oster said that for 12 to 17-year-olds who received two doses of the Pfizer vaccine, the rate was as high as 56.7 cases per million. Dosage at three weeks after vaccination.
He said that both Covid and MIS-C are known to increase the risk of myocarditis.
Despite the lack of data on myocarditis, committee member Offit said there were several reassuring factors, including the fact that children would be given lower doses, and that the risk of the condition appears to be lower in young children.
FDA scientists confirmed Data from Pfizer, concludes that the benefits of vaccination outweigh the risks in most scenarios when Covid was widespread. It was only when there were so few Covid cases in the community – as was the case in June – that it did not appear beneficial to vaccinate children.
Pfizer’s COVID vaccine is fully approved for adolescents and adults 16 years of age and older, and may be given to children and adolescents 12 to 15 years of age under emergency use authorization. It is the most widely used vaccine in the US, with more than 243 million doses given as of Monday. , according to CDC.
Next week, an advisory panel for the CDC will convene to make additional recommendations on who should get the shots, for example, whether vaccines should be limited to certain groups of children. Once CDC Director Dr. Rochelle Valensky signs off on those recommendations, young children can start getting their shots.
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