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Here are the three main topics that the FDA panel considered at its meeting:
The committee mainly focused on assessing whether the vaccines are safe for children and the potential protective gains for children and society at large if they are ultimately used on the youngest Americans.
One big consideration for regulators: Children’s developing immune systems appear to respond differently to Covid-19 than adults. Children generally develop less severe Covid-19 than adults – but a small percentage will develop a severe inflammatory syndrome called MIS-C, which adults do not have.
Over 300 children in the US have been hospitalized for the disease, and recent data from the Centers for Disease Control and Prevention shows hospital admissions are on the rise. According to federal data, children under the age of 5 and adolescents have a higher rate of hospitalization than children between the ages of 5 and 11.
“We’re going to have to have a highly vaccinated or highly immune population for years, if not decades, and it just seems silly to think that we don’t have to include children as part of it,” said Paul Offit. Pediatrician at Philadelphia Children’s Hospital.
Others were more careful. Cody Meissner, Professor of Pediatrics at Tufts University School of Medicine, Said Children Need Safe and Effective Covid Vaccination – however, argued against allowing an emergency in people under the age of 18 because the safety data currently available are insufficient.
“The burden of disease is so low and the risks just aren’t clear,” he said.
And while clinical trials aim to sniff out common side effects, some rarer vaccination-related illnesses may not emerge until vaccination becomes widespread. Federal health officials are now investigating reports of heart inflammation in some people under the age of 30 who received Moderna and Pfizer’s mRNA vaccines.
Although conditions are rare, CDC has found more cases after the second shot of an mRNA vaccine, with early data showing about 16 cases per million second doses.
The panel discussed whether it was more important to test a large cohort of children or to monitor their immune responses over a long period of time. “We don’t see any other side effects later,” said Stanford University pediatrician Hayley Gans of Covid vaccine studies. She is more likely to see larger studies over a shorter period of time to rule out even the rarest side effects like heart inflammation.
Other committee members admitted uncertainty about how Covid could spread once autumn and winter arrive, and people across much of the country are starting to spend more time indoors. Experts on the panel expressed concerns that there would be no vaccination option for younger populations until then. Several pointed out that children are still being vaccinated against diseases that are rare or non-existent domestically, such as measles and polio.
The effectiveness of the vaccine is usually calculated in clinical trials by comparing the number of infections in study subjects who received the vaccine with those who received a placebo. Experiments are designed to analyze data at predetermined points; they can be stopped if the case numbers show no benefit from a vaccination, or they can continue to determine how well a vaccine is working.
However, because children are less prone to symptomatic Covid-19 infection than adults, it could take much longer for a pediatric vaccine study to reach the FDA’s statistical bar for adult vaccine studies.
FDA officials are considering other approaches to measuring vaccine effectiveness, including studies that do monitor the types of antibodies vaccine recipients develop. When children vaccinated against Covid develop the same amount of protective antibodies as adults – especially when adults are just as well protected from disease as in clinical studies with Covid vaccines, what real-world data has so far confirmed – scientists might find the vaccine effective.
Measurement of antibody levels in children receiving a vaccine is an established approach to demonstrating efficacy in the pediatric age group, said Doran Fink, pediatrician and deputy director of the Center for the Evaluation and Research of Biologics. If these antibody concentrations are comparable to or higher than those measured in adults, the researchers consider the vaccine to be effective in children.
Most vaccinations are given in childhood and often more than one vaccination at a time. The FDA asked its advisory board to consider whether children should receive Covid vaccines in addition to routine childhood vaccinations.
The CDC recently updated their vaccination recommendations for adolescents and adults to advocate giving the Covid vaccine alongside other vaccinations. The agency did so in part because its data shows that many teens are lagging behind on routine admissions after more than a year on pandemic restrictions, with orders for tetanus-diphtheria whooping cough and human papillomavirus declining about 18 percent compared to 2019.
One small concern is whether co-administered vaccines could interact in a way that leads to more serious side effects or decreased effectiveness. “We have to check if there is any interference, not just the safety … and the immune response,” said Gans.