Nashville-Davidson, Tennessee 2021-09-28 21:38:15 –
New York (NEXSTAR) – Pfizer has submitted a study to the US Food and Drug Administration on the efficacy of the COVID-19 vaccine in children as it approaches seeking approval for extended use of shots.However, according to The Wall Street Journal, the FDA Permits cannot be granted until November.
Germany’s BioNTech, a pharmaceutical company and its partner, said it plans to require an emergency use authorization for the vaccine in children aged 5 to 11 “in the coming weeks.”
According to The Wall Street Journal, pharmaceutical companies initially aimed to file an application as early as the end of September.However, Pfizer You may not be ready to submit your application until mid-October — This means that the FDA may not be in a position to make a decision until November.
Pfizer did not immediately respond to requests for comment on why the company was waiting for the application to be submitted.
The Two Shot Pfizer Vaccine is currently available to people over the age of 12. According to the Centers for Disease Control and Prevention, an estimated 100 million people are fully vaccinated in the United States.
Pfizer tested low doses of children’s shots. The drug company said last week that it discovered that the vaccine had developed antibody levels in children to fight the coronavirus.
Earlier this month, FDA chief Dr. Peter Marks told AP that once Pfizer submitted the findings, his agency would evaluate the data “preferably within a few weeks” and the shots would be safe enough for young children. He said he would decide if it was effective.
Another US vaccine maker, Moderna, is also studying the injections in elementary school children. Results are expected later this year.
The Associated Press contributed to this report.
Pfizer COVID-19 vaccine authorization for kids 5-11 may not come before November Source link Pfizer COVID-19 vaccine authorization for kids 5-11 may not come before November