The Food and Drug Administration’s upcoming review of the Pfizer-BioNTech coronavirus vaccine for young children is without precedent in recent history.
Next week, scientific advisers to the agency will decide whether to endorse two doses of the vaccine for children 6 months to 4 years old, before clinical trials have shown the full course — three doses — to be effective. Such an authorization would be a first for the agency, many experts say.
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In fact, interim results from the trial suggested that two doses of the vaccine did not produce a strong immune response in children ages 2 to 4. Results from trials of the third dose are expected in a few weeks.
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The companies applied for authorization at the urging of the FDA, also highly unusual. The fast-moving pandemic has forced federal health officials to make important decisions with limited data before, and they argue that it’s important to begin vaccinating young children now, before a new, potentially more dangerous variant arrives.
But the agency’s review of incomplete data as a basis for authorization has alarmed some experts.
“We’ve never done that before; that’s what gives me some pause,” said Dr. Gregory Poland, founder and director of the Mayo Vaccine Research Group in Minnesota and editor-in-chief of the journal Vaccine. “I don’t like that there isn’t more data.”
The third dose is likely to build up immunity in young children, Poland and several other experts said, but it is not guaranteed to do so. With the ebbing of the omicron surge, many scientists feel the agency could afford to wait for results on the third shots, which are expected in just a few weeks.
Authorizing a vaccine before that may undermine the public’s trust in the regulatory process and deter parents who are already anxious about immunizing their children, they warn. What if the third dose simply doesn’t work and millions of parents have already given their children the first two doses?
Although children generally do not become seriously ill when infected with the coronavirus, more of them have been hospitalized during the omicron surge than at any other point in the pandemic. But multiple studies have shown that children who are hospitalized with Covid-19 tend to have conditions that predispose them to severe illness, including diabetes, chronic lung disease or heart problems.
Instead of authorizing the vaccine for all 18 million children 6 months to 4 years old, the agency might consider recommending it only for children at high risk until more evidence becomes available, some experts said.
Syringes and colorful bandages are prepared as children from local schools prepare to get vaccinated, in Pittsfield, Massachusetts. (Photo: AP)
Still, the spate of infections during the omicron surge has left some parents eager for a vaccine.
“On one side, parents are desperate to get their kids protected. On another side, there is extreme distrust,” said Natalie Dean, a biostatistician at Emory University in Atlanta. “The whole process will need to be approached with care and a lot of transparency.”
Scientific advisers to the FDA will meet Tuesday to weigh the current data, which will be released Friday. The Centers for Disease Control and Prevention could recommend the two-dose regimen for the youngest children shortly after that.
The Biden administration has promised to respect the recommendations of the advisers. “Please know that the FDA will not cut any corners in their review process,” Dr. Vivek Murthy, the surgeon general, told reporters last week. “They know that they are the gold standard that all of us rely on.”
As with the booster recommendations for all adults, the push to immunize children is part of the administration’s plan for the future, according to two federal officials familiar with the discussions: Omicron may be on its way out, but children should be protected before the next variant arrives.
“We are also concerned by the notable increase in reports of children experiencing COVID-19 long-haul symptoms, including in some cases children developing autoimmune diseases and Type 1 diabetes after having had COVID-19,” said Stephanie Caccomo, an FDA spokesperson.
Even if vaccination of young children begins in April, it will be summer before they have had three doses, noted Dr Diego Hijano, a pediatric infectious disease specialist at St. Jude Children’s Research Hospital and an investigator for the Pfizer-BioNTech trial. “For sure, by summer we may have a variant of concern that’s spreading around.”
But other researchers said preparing for the future was not a compelling enough reason to get ahead of the third-dose clinical trial. The risk-benefit calculus for young children now is very different from that of adults at the start of the pandemic, Poland said.
“When we’re making these considerations for kids, we’re not making it in the smoke and fog and chaos of war,” he said.
“I would, as a vaccinologist, just have to sit and think about it a little bit,” Poland added of the FDA’s decision. “I can just guess that that puzzling is going to take a lot longer for the majority of America’s parents.”
The vaccine has been safe in other age groups, and even the rare risk of heart problems in adolescents is unlikely in prepubescent children. Still, vaccine hesitancy is running strong among parents of younger children.
The FDA authorized the Pfizer-BioNTech vaccine for children 5-11 in October. But only about 1 in 5 of the 28 million children in that age group has received two shots of the vaccine, according to CDC data.
The agency is under fire for approving an unproven Alzheimer’s drug called Aduhelm. A vaccine for the youngest children is likely to be even more fraught, and any regulatory missteps could be used to discredit the vaccines, said Angela Rasmussen, a virus expert at the Vaccine and Infectious Disease Organization at the University of Saskatchewan in Canada.
Evaluating the vaccine now advances the authorization only by a few weeks, she noted.
“Isn’t it worth taking the time to make sure regulatory decisions are strongly supported with data,” she said, “given the potential long-term stakes for vaccine confidence and uptake?”
