WASHINGTON – Pfizer and BioNTech announced Tuesday that they had provided the Food and Drug Administration with data showing their coronavirus vaccine is safe and effective in children ages 5-11.
The companies said they would make a formal application to regulators to allow a pediatric dose of their vaccine to be administered in the United States in the coming weeks. Similar applications are submitted to European regulators and other countries.
The announcement, which comes as U.S. schools resumed amid a violent wave of the highly contagious Delta variant, brings many parents one step closer to the likelihood of a coronavirus vaccine for their children.
When asked when the vaccine might be released to children, Dr. Albert Bourla, CEO of Pfizer, on Tuesday said he did not want to pre-empt regulators.
“It is inappropriate to say how long it will take the FDA to review the data,” said Dr. Bourla performing at the Atlantic Festival hosted by The Atlantic magazine. “You should take as much time as you think is appropriate.” He added that approval around Halloween, as some health officials have suggested, is possible, “one of the options and it’s up to the FDA.”
Just over a week ago, Pfizer and BioNTech announced positive results from their clinical study involving more than 2,200 participants in this age group. The FDA has announced that it will analyze the data as soon as possible. Dr. Peter Marks, the agency’s top vaccine regulator, said recently that approval, “surprise,” “could come in“ weeks, not months, ”of the companies’ submission of the data.
The companies announced last week that their vaccine had been shown to be safe and effective at low doses in children ages 5-11, giving hope to parents in the United States who fear returning to face-to-face schooling puts children at risk the infection.
About 28 million children ages 5-11 would be eligible for the vaccine in the United States, far more than the 17 million ages 12-15 who were eligible for the vaccine in May.
However, it is not clear how many will be vaccinated in the younger cohort. Vaccinations in older children have lagged: only about 43 percent of children ages 12-15 in the United States were fully vaccinated, compared with 67 percent of adults, according to federal data.
While many remain anxious to vaccinate their children, opinion polls suggest that some parents have reservations. A survey published last month by the Kaiser Family Foundation found that 26 percent of parents of children ages 5-11 would vaccinate their children “immediately” once doses were approved for their age group, 40 percent said they would “Wait and see” how the vaccine worked before and 25 percent said they would not vaccinate their child at all.
Studies have shown that unvaccinated children who contract the coronavirus tend not to get seriously ill, which has led some parents to wonder whether the risks of a new vaccine outweigh the benefits.
And some parents who have been vaccinated themselves have expressed concerns about the relatively small scale of child trials and the lack of data on the long-term safety of the vaccinations. The Pfizer-BioNTech and Moderna vaccines have rarely been linked to heart disease, myocarditis, an inflammation of the heart muscle, particularly in younger men. Concerns about this potential side effect could be alleviated by the lower doses that children of the Pfizer BioNTech vaccine are supposed to receive.