It could be a happy Halloween for kids and parents in the United States this year.
Pfizer and BioNTech on Monday announced that its COVID-19 vaccine was shown to be safe and effective in kids ages 5 to 11 in a trial, which consisted of 2,268 participants. The companies plan to submit the data to the FDA "with urgency," Pfizer CEO Albert Bourla said. On CBS Mornings, former FDA Commissioner Scott Gottlieb said this means that if all goes well, kids in this age group could potentially start getting vaccinated as soon as Halloween.
"Now that they have the data, they could be ready to file this within days with the Food and Drug Administration," Gottlieb said.
He noted that the FDA has said that reviewing the vaccine data will take a matter of weeks, and, pointing to his own experience at the agency, he suggested this likely means "four to six weeks." Given that, "I think that there's a possibility you could have a vaccine as early as around Halloween — maybe a little bit later, you might lose a week here or there," Gottlieb explained.
The FDA has already authorized the Pfizer vaccine for kids between 12 and 15, but parents have been anxiously awaiting authorization for younger children, especially since the start of the new school year. BioNTech CEO Dr. Ugur Sahin said Monday that "we are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season."
Pfizer's announcement also specified that the vaccine was effective using a dose three times smaller than the amount that's being administered for those 12 and older, which Gottlieb explained was the "optimal dose that had the best compromise between reducing the number of vaccine-related side effects, while still providing efficacy that's on par with what we saw in 16 to 25 year olds."