(Washington) The COVID-19 vaccination for children under 5 suffered another month-long delay on Friday as U.S. regulators abruptly curtailed efforts to expedite the review of vaccines Pfizer is testing for children. youth.
Posted at 8:45 p.m.
The Food and Drug Administration (FDA), concerned about the adverse effects of the omicron variant on children, had taken the extraordinary step of urging Pfizer to seek approval of the very low-dose vaccine before it was clear whether the whole -little ones need two or three injections. The agency’s plan could have allowed vaccination to begin within weeks.
But on Friday, the FDA backtracked and said it had become clear the agency needed to wait for data on the effectiveness of a third dose for the youngest age group. Pfizer said in a statement it expects the data in early April.
The head of vaccines at the FDA, Dr.r Peter Marks, said he hoped parents would understand the agency’s decision was part of its careful scientific review of the evidence Pfizer has submitted so far.
This information “made us realize that we needed to see the data from the ongoing third dose trial in order to make a decision,” Marks told reporters. “We take our responsibility to review these vaccines very seriously, because we are also parents,” he added.
The country’s 18 million children under 5 are the only age group not yet eligible for vaccination.
Vaccine experts had worried about the sudden rush to assess Pfizer’s vaccine – and are now wondering what parents will think of the back and forth.
“I think they made the right decision to be cautious and wait for data from the third dose,” said Dr.r Jesse Goodman of Georgetown University, former head of vaccines at the FDA.
“It was great to hear that there might be some promising data from two doses, but it was received as, ‘Hey everyone, you can expect a vaccine in a couple of weeks,'” a- he added. I think this message is getting very confusing for people. »
This is not the first deadline. Pfizer originally expected to find out last December whether the extra-low doses worked for children under 5. Preliminary results of the study showed that two injections were safe and potent enough to provide good protection for babies as young as 6 months old. But once toddlers reached preschool age – ages 2 to 4 – two doses weren’t protective enough, prompting a third to be added to the study.
So it was a surprise when a few weeks ago the FDA urged Pfizer and its partner BioNTech to go ahead and seek clearance. Next week, the agency’s independent scientific advisers were due to publicly debate whether it was okay to start giving toddlers two injections before there was evidence that a third would give them the extra protection they needed. – a very unusual decision.
On Friday, the FDA abruptly canceled that meeting, promising to hold it once Pfizer submits evidence for the third dose.
Pfizer aims to give children as young as 6 months old injections containing one-tenth the dose given to adults – two injections three weeks apart followed by a third at least two months later.
This is a lower dose than that received by young people aged 5 to 11, which is one third of the adult dose.
Vaccination rates were lower in children than in other age groups. As of last week, only 22% of children ages 5 to 11 and just over half of those ages 12 to 17 were fully immunized, according to the American Academy of Pediatrics. Nearly three-quarters of adults are fully immunized.