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Emergency clearance for Covid-19 vaccines in children under 12 could come in early winter, a Food and Drug Administration official said on Thursday, a move that could bring relief to many. many parents who could not immunize their children. The agency then hopes to move quickly to full vaccine approval for this age group.
A sticking point for some families who remain hesitant, the official said, is that the vaccines currently in use are being given under emergency use authorization and have not been fully approved by the FDA. Full approval, if it comes soon after the emergency round, could alleviate this concern.
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Covid-19 vaccines have only been authorized for people aged 12 and over in the United States, and none have yet received full approval.
Moderna and Pfizer-BioNTech both launched trials of their Covid-19 vaccines for children under 12 in March. The results are expected in the fall, and it will take time for FDA officials to review the drug companies’ claims.
The regulatory agency is requesting four to six months of tracking safety data for children under 12, the FDA official said. Only two months of follow-up data were needed for clinical trials in adults.
This additional data could facilitate the process of granting full approval. Six months of tracking data is required for what’s called a Biologics License Application, or BLA.
So far, only Pfizer-BioNTech has applied for full approval of its vaccine for adults 18 years of age and older. The FDA official said granting full approval for adults is the agency’s highest priority.
Pfizer said in a statement to NBC News that it anticipates the results of its clinical trials in children aged 5 to 11 in September, and then may apply for emergency use authorization. “Data for children aged 2 and under 5 could arrive soon after,” the company said, adding that results for children aged 6 months to 2 years may not be released until October or November.
Dr Buddy Creech, a lead investigator in the Moderna KidCOVE clinical trials, which includes children as young as 6 months old, predicted a deployment of pediatric data similar to Pfizer’s.
“I can’t imagine, except maybe for 6 to 11 year olds, that we’re going to have too much data before the end of fall,” said Creech, also pediatric infectious disease expert and director of the Vanderbilt vaccine. The research program at Vanderbilt University Medical Center in Nashville, Tennessee, said.
Results on children 5 and under may take longer, he added. “There is still a lot of work to be done. “
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A safe and effective vaccine for children is an important tool in stopping the spread of Covid-19, especially with the rapid increase in the more transmissible delta variant.
There is no indication that the variant changes the virus to be more harmful to children. But its highly contagious nature means unvaccinated people, which include all children under 12, are more vulnerable.
“Since children are one of the unvaccinated groups, we will see more cases in children,” said Dr. Richard Besser, pediatrician and former acting director of the Centers for Disease Control and Prevention. “We will see more hospitalizations in children, and unfortunately we will see more deaths in children.”
Besser, who is the current chairman of the Robert Wood Johnson Foundation, said he hopes the FDA will move quickly to full vaccine approval.
“A number of people say it will influence their decision to get the vaccine,” he said.
Some pediatric infectious disease physicians are not convinced that full approval, rather than EUA, would have much impact on vaccine reluctance.
“In terms of vaccine approval, there isn’t much of a functional difference” between emergency use authorization and full approval, said Dr Sean O’Leary, vice-chairman of the Committee. of Infectious Diseases from the American Academy of Pediatrics.
As of July 8, more than 4 million children had been diagnosed with Covid-19, or 14.2% of all cases, according to the American Academy of Pediatrics. At least 335 children, aged 17 and under, have died from Covid-19, according to the latest CDC data.
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