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As the delta variant spreads, posing an increased risk for those who are not vaccinated, demand has skyrocketed for a vaccine that will protect young children who are not yet eligible – a group facing more cases than never during the pandemic.
And although experts still consider it rare for children to become seriously ill from the virus, not getting vaccinated makes them more vulnerable. More than 94,000 children were diagnosed with COVID last week, according to the American Academy of Pediatrics, and hospitals across the country are increasingly reporting children in their pediatric COVID units.
Here’s what we know so far about when a safe and effective vaccine for children under 12 will be cleared by the Federal Drug Administration:
1st shots for young children expected at the end of autumn, at the beginning of winter
Pfizer has announced that it will submit vaccine safety data for children aged 5 to 11 by the end of September. Moderna said he would do it in the middle of fall. It will then be up to the FDA to decide how quickly to grant clearance.
In general, federal and industry officials have said they expect the first vaccines for children aged 5 to 11 can take place by the end of this year or early 2022. The timeline of a vaccine for children under 5 is less certain, but officials have said they hope a green light for toddlers and infants will follow soon after.
But the precise timing is fluid. Clinical trials are still ongoing and the FDA has indicated it wants to expand the pool of children registered as volunteers. More volunteers increase the likelihood that even the rarest side effects can be detected before its nationwide rollout.
The vaccine for children aged 5 to 11 would have the same composition, but a lower dose. For Pfizer, children under 12 would receive 10 micrograms, while every 12 and over would receive a dose of 30 micrograms.
The FDA is under extraordinary pressure to act quickly.
Some have urged the FDA to act faster to allow the shooting because of the toll the delta variant takes on children. In a recent letter to the chief of the FDA, the president of the American Academy of Pediatrics said last week showed the “largest week-over-week percentage increase in pediatric COVID-19 cases since the start of the pandemic, “to 72,000 pediatric cases of COVID in one week, up from about 39,000 reported the week before.
“Put simply, the Delta variant has created a new and urgent risk for children and adolescents across the country, as it has also done for unvaccinated adults,” wrote AAP President Lee. Savio Beers, in a letter to Acting FDA Administrator Janet Woodcock.
In an effort to speed up clearance, Beers suggested that the FDA clear the vaccines with data from already enrolled children, and then continue to monitor an expanded second group of children.
In an interview with ABC News Live on Monday, Beers said the AAP feared that the recent FDA decision to double the number of children participating in vaccine trials could delay a vaccine’s schedule at a critical time and that “The data is there” with the current cohort for the FDA to act very soon.
“We really think we need to approach the COVID vaccine clearance trials for children with the same urgency that we have done with adults,” Beers said in the interview.
FDA insists it won’t cut corners
While the FDA insists it won’t cut corners, according to a government official, asking more children to participate in trials shouldn’t delay the vaccine approval process. This is because parents have been eager to register their children for the vaccine.
The FDA is also not likely to require an extended period of safety data collection for the younger age group, a consideration the FDA ultimately decided was not necessary as long as more children were enrolled. for testing.
FDA vaccine chief Peter Marks has repeatedly defended the FDA’s timing and decision-making process, saying the agency will be deepened.
“Just so everyone understands, we’re going to be very careful when we move on to the smaller kids,” he said at an event in May with the BlackDoctor.org group, a health resource that focuses on raising awareness among African Americans.
“We need to reduce the dose of the vaccine, we are more careful about side effects, development takes longer,” Marks said.
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