The review that the Food and Drug Administration (FDA), the US food and drug enforcement agency, will soon conduct on the Pfizer-BioNTech vaccine for young children is unprecedented in recent history.
Next week, the agency’s scientific advisors will decide whether or not to endorse the application of two doses of vaccine to children aged 6 months to 4 years before clinical trials have demonstrated that the complete vaccination process — three doses — it is effective. Such an authorization would be the first in the agency’s history, according to many experts.
In fact, partial test results indicate that two doses of the vaccine do not produce a strong immune response in children aged two to four years. Results of tests with the third dose of the vaccine should only appear within a few weeks.
The companies applied for authorization at the insistence of the FDA, which is also highly unusual. In the past, the rapid advance of the pandemic has forced US federal health officials to make important decisions based on limited data, and they argue that it is important to start vaccinating young children now, before a new and potentially more dangerous variant emerges.
But the agency’s review of incomplete data as a basis for possible authorization has alarmed some experts.
“We’ve never acted this way before; that’s what makes me hesitate,” said Dr Gregory Poland, founder and director of the Mayo Vaccine Research Group in Minnesota and editor-in-chief of the science journal Vaccine. “I don’t like the fact that there is no more data.”
The third dose will likely help young children develop immunity, Poland and several other experts said, but there is no guarantee that it will. With the omicron variant receding, many scientists feel the agency could wait for the results of the third dose test, which should be out in just a few weeks.
Authorizing a vaccine in advance can undermine public confidence in the regulatory process and discourage parents, already anxious about the need to vaccinate their children, experts warn. What if the third dose just doesn’t work and millions of children have already received the initial two doses?
While children in general do not become seriously ill when infected with the coronavirus, the number of children who ended up hospitalized grew more during the omicron outbreak than at any other time in the pandemic. But multiple studies have shown that children hospitalized for Covid-19 tend to have conditions that predispose them to the most severe form of the disease, including diabetes, chronic lung disease or heart problems.
Rather than authorizing the vaccine for all 18 million children aged six months to four years old in the United States, the agency could consider recommending it only for children at high risk, until more concrete evidence is available. become available, some experts said.
Still, the surge in the number of infections during the outbreak of the omicron has led many parents to look forward to the vaccine.
“On the one hand, parents are desperate to protect their children as quickly as possible. On the other hand, there is extreme mistrust,” said Natalie Dean, a biostatistics expert at Emory University in Atlanta. “The whole process needs to be approached with care and a lot of transparency.”
FDA scientific advisors will meet on Tuesday (15) to evaluate current data, which will be released on Friday (18). The Centers for Disease Control and Prevention (CDC) may recommend a two-dose vaccine regimen for young children shortly thereafter.
The Biden administration promised to respect the advisers’ recommendations. “Please be aware that the FDA will not take any shortcuts in its review process,” said Vivek Murthy, US Surgeon General. [o principal assessor de saúde do Executivo]. “The agency knows what the standard of conduct is that we all rely on.”
As with recommending an additional dose of vaccine for all adults, the effort to immunize children is part of the government’s plan for the future, according to two federal officials familiar with the discussions: the omicron variant may be in retreat, but children need to be protected before the next variant arrives.
“We are also concerned about the remarkable rise in the number of children experiencing lasting symptoms of Covid-19, which in some cases includes the development of immune system diseases and type 1 diabetes, after they have been through Covid-19” , said Stephanie Caccomo, an FDA spokeswoman.
Even if the vaccination of young children starts in April, the third trimester would arrive before they have received all three doses, said Diego Hijano, an infectious disease physician at St. Jude Children’s Research Hospital and one of the researchers participating in the trial of the new vaccine. from Pfizer-BioNTech. “And for sure by the third quarter we could have one more worrisome variant spreading.”
But other researchers said preparation for the future was not a strong enough reason to act before the results of the third dose clinical trial. The cost-benefit calculation for young children is very different from what prevailed for adults at the beginning of the pandemic, Poland said.
“When we make these kinds of considerations about children, we don’t make them in the fog and chaos of war,” he said.
“As a vaccine expert, my recommendation would be to stop and think about this for a moment,” Poland added of the FDA’s decision. “And I can guess the indecision is going to be even longer for most US parents.”
As a vaccine expert, my recommendation would be to stop and think about it for a while. And I can guess that the indecision is going to be even longer for most US parents.
The vaccine has proven safe for other age groups, and even the rare risk of heart problems in teenagers is unlikely to apply to children before puberty. But hesitation over the vaccine remains high among parents of younger children.
The FDA authorized the Pfizer-BioNTech vaccine for children ages 5 to 12 in October. But only 20% of children in this age group have ever received two doses of the vaccine, according to CDC data.
The agency is under fire for approving an unproven Alzheimer’s drug called Aduhelm. A vaccine for younger children is likely to cause even more controversy, and any blunders by regulatory authorities could be used to discredit 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 will advance authorization by just a few weeks, she pointed out.
“Is it no longer worth the wait to make sound regulatory decisions that are strongly supported by data,” she said, “given what could be at stake in the longer term for acceptance and trust in vaccines?”
Translation by Paulo Migliacci.
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