Pfizer submitted safety and efficacy data for its COVID-19 vaccine to US drug regulators in October to gain authorization for shots for children ages 5 to 11, two company executives said on Tuesday. is considering doing.
Pfizer’s COVID-19 vaccine, made with German partner BioNTech, currently authorized for emergency use only in the United States for those 12 to 15, was approved last month for Americans 16 and older .
Pfizer is testing the safety, tolerability, and effectiveness of the vaccine in children ages 6 months to 11 years. Pfizer CEO Frank D’Amelio told a Morgan Stanley conference on Tuesday that data from the trial for people ages 5 to 11 is expected by the end of September.
It will set up an application for emergency use authorization to the Food and Drug Administration (FDA) in early October for that age group.
According to D’Amelio, if all goes well, an application for authorization for children aged 6 months to 5 years will be filed weeks later.
Pfizer CEO Albert Boerla said on a separate forum that submissions for the older group could actually arrive as late as September.
“Again, it’s up to the FDA to take their time, and then make a decision,” he said, CNBC reported.
He said that the applications for the youth group could come by the end of October.
The Pfizer vaccine is the only vaccine currently used in the United States for anyone between the ages of 12 and 18.
BioNTech said last week that it expects to file test results “with regulators around the world” for children ages 5 to 11.
Children are at very low risk of contracting severe cases of COVID-19, the disease caused by the CCP (Communist Party of China) virus, but Pfizer says its scientists believe vaccinating children may help in herd immunity. will contribute to, or provide protection against, the virus as a whole. population.
Federal health officials have also said they want children to get a vaccine against the virus.
“While we are waiting for companies to submit data to the FDA, we anticipate that will happen in the fall,” Rochelle Valensky, director of the Centers for Disease Control and Prevention (CDC), said this week. “We’ll look at that data from the FDA to the CDC, with the urgency we all feel to get our kids vaccinated and we’re looking forward to the end of the year.”
This News Originally From – The Epoch Times