A panel of independent advisors to the Food and Drug Administration recommends that the agency issue an emergency approval for the Pfizer BioNTech vaccine in children ages 5-11. There were 17 votes in favor and one abstention.
The FDA panel accepted Pfizer’s data showing the vaccine is safe and 90.7% effective in preventing COVID-19 infection in this age group.
The agency usually follows the advice of its expert panels, but is not obliged to do so. She will make a decision in the next few days. If the FDA approves the vaccine for these younger children, which is likely, another panel of experts advising the Centers for Disease Control and Prevention would make its own recommendations next week and offer guidelines for use in that age group.
The vaccine offers broad defense against COVID-19 and “effectively neutralized the Delta variant” in young children, said Dr. William Gruber, Senior Vice President, Clinical Research and Development of Vaccines at Pfizer, during the committee hearing.
A dose of Pfizer for infants contains one third of the amount of active ingredient compared to the adult dose. Children received a second dose 21 days or more after their first injection.
Gruber said the dose size was chosen to “strike the right balance” between providing strong immunity and limiting side effects. He said the side effects observed in the company’s studies “do not suggest safety concerns”. An FDA review supported this conclusion.
Children ages 5-11 made up about 9% of all reported COVID-19 cases in the United States and currently account for about 40% of all pediatric COVID-19 cases, says Dr. Doran Fink, assistant clinical director of the Vaccines and Related Products Division for the FDA. Currently, the fall rate in children between the ages of 5 and 11 is “almost the highest” of all age groups, he says.
Fink and others who testified at the meeting admitted that serious effects of infection, including prolonged COVID-19, hospital stays, and deaths, are less common in children than adults. However, they also argued that the significant number of serious illnesses in young children was a cause for concern.
Unvaccinated children with COVID-19 can develop a serious complication called multisystem inflammatory syndrome or MIS-C, as well as inflammation of the heart muscle called myocarditis.
Myocarditis occurs naturally after infections with other viruses and has also been seen as a rare side effect after vaccination with the two mRNA vaccines Pfizer and Moderna, especially in young men.
Myocarditis was a focus of the scientific presentations and discussions about the potential risks of the vaccine if it were approved for use in young children.
In studies of young children that Pfizer submitted to the FDA, the researchers did not observe any cases of myocarditis. But dr. Leslie Ball, an FDA medical officer, said the studies seeking emergency approval weren’t necessarily large enough to necessarily reveal an unusual side effect like myocarditis.
Overall, the incidence of serious adverse events reported in Pfizer’s studies was less than 2 in 1,000, Ball said, and all of them were found to be unrelated to the vaccine. Less serious side effects were more common, including swollen lymph nodes in some children and symptoms such as injection site pain, fatigue and headache, she said.
Several people who opposed the approval testified during a public statement citing cases of vaccine-related side effects. They claimed that children don’t get sick as often as adults and that the possible risks of side effects outweigh the possible benefits.
The committee discussed concerns about a higher incidence of myocarditis in adolescents who received the Pfizer vaccine.
“I think it’s always nerve-wracking when asked to make a million dollar decision based on just a few thousand children studying,” said committee member Paul Offit, a pediatrician at Children’s Hospital of Philadelphia. But Offit said he was “reassured” that the number of myocarditis cases in children ages 5-11 was lower than that of older teenagers and young adults.
Capt. Amanda Cohn, a doctor and medical officer at the CDC and also a voting member of the FDA committee, said the number of children in the Pfizer trials is similar to the number used to approve other childhood vaccines.
“I don’t want to minimize the risk,” Cohn told the committee during a voting debate. “For now, based on the body of the evidence, the benefits outweigh the risk,” she said.
“We have incredible safety systems in place to monitor the potential for myocarditis in this age group and we can react quickly,” she added. “To me the question is pretty clear. We don’t want children to die of COVID, even if there are far fewer children than adults, and we don’t want them to stay in intensive care.”
Pediatric cardiologist Matthew Oster, who works with the CDC’s Center on Birth Defects and Developmental Disabilities, presented an extensive review of what is known about this side effect. He said that both historical studies of myocarditis before the pandemic, during the pandemic, and after vaccination showed that myocarditis is most common in children and adults between the ages of 16 and 29 and is much more likely in men than women. Most children and teenagers recover from myocarditis.
The committee’s recommendation comes as more than 1.9 million cases have been reported in children ages 5-11, with about 8,300 children hospitalized to date, according to the CDC. About a third of these hospitalized children had to be treated in the intensive care unit. The hospitalization rate for colored children is three times higher than for white children.
Many public health professionals see an urgent need to start vaccinating young school-age children, in part to combat the unequal impact of the pandemic on people of color.
Dr. CDC’s Fiona Havens provided the FDA committee with data showing that COVID-19 outbreaks closed 272 school districts between August and early October, affecting 2,074 schools. 1,069,116 students and 68,718 teachers were affected. She said there was a disproportionate impact on children of color.
Havens said 5,217 children had developed MIS-C, a serious complication of COVID-19. Almost 40% of the cases occurred in children between 6 and 11; more than 60% of these cases involved children of color. The complication causes severe inflammation of several organ systems in the body.
On the long-term effects of infection in children, Havens said there is a lack of data on how often children develop a version of long-term COVID, although a study from the UK found that 7 to 8% of children had symptoms greater than 12. showed weeks after the initial diagnosis.
The FDA has modeled several scenarios to estimate the effects of vaccinating children. One showed that vaccinating 1 million children, ages 5-11, would prevent 58,000 infections, 241 hospitalizations, and one death. The same 1 million children could have between 22 and 106 cases of vaccine-related myocarditis. Most are expected to make a full recovery.
An FDA adviser Hong Yang said that in most scenarios, the benefits of vaccination in the population of children ages 5-11 “clearly outweighs” the low risk of developing myocarditis.
However, when levels of COVID-19 transmission in the community are low, there may be more hospitalizations for myocarditis than COVID-19, Yang noted. Given the high rates of COVID-19 transmission in most areas of the United States, the overall benefits of vaccination may “still outweigh the risks,” she concludes.
Dr. James Hildreth, a committee member and president of Meharry Medical College in Nashville, Tennessee, ultimately voted to approve the vaccine but said it was a “challenging decision”.
Hildreth said he was surprised to learn that up to 40% of children in this age group have been infected with the coronavirus, which he believes could mean up to 30 million children may already have some form of immunity. And he said he was “disappointed with that too.” [low] Minorities “enrolled in the Pfizer studies” because they bear the brunt of illness and hospitalization. “
“It just seems to me in a way that we vaccinate children to protect adults,” Hildreth said. “It should be the other way around.” The focus should be on getting adults vaccinated to protect the children.
He said he voted yes “because I want to make sure that the children who really need the vaccine – especially the black and brown children in our country – get the vaccine.”
Pfizer’s Gruber said other benefits of early childhood vaccination would include potentially reduced virus transmission, improved herd immunity, and increased personal learning – all of which aids the child’s development.
However, Ball said the FDA’s analysis failed to determine whether the vaccination had any effect on the spread of the virus. Gruber said that given the similar antibody response seen in adults and the fact that high levels of antibodies have slowed transmission in older populations, “it is reasonable” that the same would apply to children ages 5-11.
Not only is the pediatric dose to be used less than that in adults, but the formulation is slightly different; The company is using a different substance to maintain the vaccine’s biological stability so it can be refrigerated for up to 10 weeks. The cans for people aged 12 and over must be stored frozen and have a more limited shelf life.