Washington – Pfizer and BioNTech announced Tuesday that they are providing the Food and Drug Administration with data that their coronavirus vaccine company says is safe and effective in children ages 5-11.
The companies say they will formally ask regulators in the coming weeks to approve pediatric doses of their vaccine in the US. Similar requests were made by European regulators in other countries.
The announcement comes as American schools emerge amid a brutal wave of the highly contagious version of Delta, bringing many parents one step closer to the prospect of a coronavirus vaccine for their children.
When asked Tuesday when the vaccine might be approved for children, Dr. Albert Boerla, CEO of Pfizer, said he didn’t want to be in front of regulators.
“It is inappropriate to comment on how long it took the FDA to review the data,” said Dr. Borla in a statement at the Atlantic Festival hosted by Atlantic magazine. “You have to spend as much time as you want.” He added that Halloween clearance, which some health officials may have suggested, “is a possibility and depends on the FDA”.
Just a week ago, Pfizer and BioNTech announced the positive results of their clinical study with more than 2,200 participants in this age group. The FDA said it would analyze the data as soon as possible. The best vaccine regulatory agency, Dr. Peter Marx recently said that, with the exception of “surprises”, approval could come “within weeks, months” after the company submitted the data.
The company announced last week that their low-dose vaccine has been shown to be safe and effective in children ages 5-11, giving hope to parents in the United States who worry that individual withdrawal training is putting children at risk. infection.
About 28 million children ages 5-11 will be eligible for the vaccine in the United States, with more than 17 million ages 12-15 eligible for the vaccine as of May.
But it is not clear how many people in the youth group will be vaccinated. Vaccination of older children lags behind: only about 43 percent of children ages 12-15 in the United States are fully vaccinated, according to federal statistics, compared with 67 percent of adults.
While many are happy for their child to be vaccinated, polls show that some parents are against it. A study published last month by the Kaiser Family Foundation found that 26% of parents of children ages 5-11 would vaccinate their children “immediately” after agreeing to a dose for their age group, 40% said. That they “wait and see” how the vaccine works before doing so and 25 percent said they would not vaccinate their child at all.
Studies show that unvaccinated children infected with the coronavirus are not seriously ill, leading some parents to wonder whether the risks of the new vaccine outweigh the benefits.
And some vaccinated parents expressed concern about the relatively small scale of pediatric trials and the lack of data on the long-term safety of vaccination. Pfizer-BioEntech and Moderna vaccines have rarely been associated with myocarditis, an inflammation of the heart muscle, especially in young men. Concerns about these potential side effects can be reduced by the low doses prescribed to children receiving the Pfizer BioNTech vaccine.