Pfizer is expected to apply to the Food and Drug Administration for emergency clearance to administer its coronavirus vaccine to children ages 2-11 in September, the company told Wall Street analysts and reporters on Tuesday during its quarterly call for profits.
The company also plans to file for full approval of the vaccine this month for people ages 16 to 85. Clinical study data on the safety of his vaccine in pregnant women should be available by early August.
By early next week, the FDA is expected to issue an emergency clearance that will allow the vaccine to be used in children ages 12-15. This is an important step in the US fight against Covid.
The Pfizer BioNTech vaccine will be given to adults as part of an emergency clearance the companies received in December. Gaining full FDA approval would, among other things, enable the companies to commercialize the vaccine directly to consumers. The approval process is expected to take months.
“Full approval is a welcome indicator of the continued safety and effectiveness of the Pfizer vaccine,” said Saskia Popescu, an infectious disease epidemiologist at George Mason University, in an email.
The Pfizer BioNTech coronavirus vaccine was the first to receive emergency approval in the United States. Emergency permits are temporary and can be revoked once a public health emergency has ended.
Full approval would allow the vaccine to stay in the market when the pandemic wears off. This could also make it easier for businesses, government agencies, schools, and other institutions to request vaccination. For example, the University of California and California State University school systems have announced that after coronavirus vaccines are fully FDA approved, students, faculties, and staff will need to be vaccinated. The U.S. military, where many troops have turned down coronavirus vaccines, has said it wouldn’t make them mandatory as long as they only have an emergency permit.
Pfizer’s announcements come as the rate of vaccination in the US has slowed. “We are essentially nearing the end of the vaccination of those who willingly waited to line up to receive it,” said Rupali Limaye, a public health researcher at Johns Hopkins who studies vaccine use. “And so, in my opinion, the next surge will be more critical than ever.”
Full FDA approval could help build confidence in the vaccine, especially among people who are still concerned about how quickly it was developed, said Dr. Limaye. “I think people still have concerns even knowing that no corners have been cut,” she said. “It will make people say, ‘OK, it has been thoroughly checked.'”
White House press secretary Jen Psaki said at a news conference Tuesday that she does not want to be ahead of the FDA but that the government is preparing to “make this available to additional, younger populations.”
Dr. Popescu said the opportunity to allow children in the United States to use the vaccine was both exciting and frustrating. “We have key people around the world who cannot get vaccines and countries that may not have access for a year or more, so we need to add global access to this conversation,” she said.
As of Tuesday, more than 131 million doses of the Pfizer BioNTech vaccine had been administered in the US, according to the Centers for Disease Control and Prevention. They make up just over half of all doses administered in the country to date.
Pfizer’s managing director, Dr. Albert Bourla said the company reached out to the FDA on Friday with new data to convince the agency that the vaccine can be stored at refrigerator temperatures and not frozen for up to four weeks. Currently the limit is five days. He said the company was working on an updated version of the vaccine that could potentially be refrigerated for up to 10 weeks and hoped to have supportive data for that by August.
Rebecca Robbins and Dan Slotnik contributed to the coverage.