Pfizer plans to apply for an emergency permit from the Food and Drug Administration in September. Coronavirus vaccine The company told Wall Street analysts and reporters on a quarterly phone call on Tuesday to children aged 2 to 11.
The company also said it plans to apply for full approval of the vaccine for people between the ages of 16 and 85 this month. He said he plans to obtain clinical trial data on vaccine safety in pregnant women by early August.
By the beginning of next week, the FDA will Scheduled to be issued An emergency use authorization that allows the vaccine to be used in children aged 12 to 15 years. This is a big step in the fight against Covid in the United States.
The· Pfizer-BioNTech Vaccine Given to adults under Emergency use authorization The company Received in December.. With full FDA approval, companies, among other things, can sell vaccines directly to consumers. The approval process is expected to take several months.
“Full approval is a welcome indicator of the continued safety and efficacy of the Pfizer vaccine,” Saskia Popescu, an infectious disease epidemiologist at George Mason University, said in an email.
Pfizer-BioNTech Coronavirus Vaccine was the first to receive an emergency permit in the United States. Emergency permits are temporary and can be revoked at the end of a public health emergency.
Full approval allows vaccines to remain on the market as the pandemic declines, and may make it easier for businesses, government agencies, schools, and other organizations to request vaccination. For example, the University of California and California State University school system Announced Once the coronavirus vaccine is fully approved by the FDA, students, faculty and staff will need to be vaccinated.I’ve seen many troops Reject coronavirus vaccineStates that they will not be required as long as they have only emergency permits.
Pfizer’s announcement is coming As the pace of vaccination in the United States It is decelerating. Ruparilimaier, a Johns Hopkins public health researcher studying the use of vaccines, said: “So the next push will be more important to me than ever.”
Full approval from the FDA may help increase confidence in the vaccine, especially among those who may have protracted concerns about how quickly the vaccine was developed, Dr. Limaye said. I did. “Even if you know that the corners aren’t cut, I think people are still concerned about it,” she said. “It encourages people to say,’OK, it’s been thoroughly scrutinized.’ “
White House spokesman Jen Psaki said at a press conference Tuesday that he didn’t want to stay ahead of the FDA, but the government is preparing to “make additional young people accessible to the FDA.” It was.
Dr. Popesque said the possibility of opening up vaccine use to children in the United States is exciting and frustrating. “There are essential workers around the world who cannot be vaccinated, and in some countries they have been inaccessible for more than a year, so we need to extend this conversation to include global access,” she said.
As of Tuesday More than 131 million doses According to the Centers for Disease Control and Prevention, some of the Pfizer-BioNTech vaccines were given in the United States. They make up a little more than half of all doses ever administered domestically.
Dr. Albert Bourla, Pfizer’s CEO, said he hopes the company will submit new data to the FDA on Friday to allow vaccines to be stored in the refrigerator at refrigerator temperatures for up to four weeks instead of freezing. It was. Currently the limit is 5 days. He said the company is working on an updated version of the vaccine that could be stored in the refrigerator for up to 10 weeks and hopes to get supporting data in August.
Rebecca Robins And Dan Slotnik contributed to the report.
Pfizer seeks approval to give children Covid vaccine
Source link Pfizer seeks approval to give children Covid vaccine