Pfizer and BioNTech are set to seek FDA approval in November for their COVID vaccine to use in children between 6 months and 5 years old.
Pfizer and BioNTech are set to seek U.S. Food and Drug Administration (FDA) approval in November for their Chinese coronavirus vaccine to use in children between 6 months and 5 years old.
During the Morgan Stanley Global Virtual Healthcare Conference on Tuesday, Pfizer Inc. Chief Financial Officer and Executive Vice President of Global Supply Frank A. D’Amelio said the company is currently conducting Phase 3 studies for children between the ages of 6 months and 11 years old.
“Now we expect to have safety and immunogenicity data for children between ages of 5 and 11, we expect to have that data by the end of September, and then we would expect to file that with the FDA in early October for a potential EUA,” D’Amelio said, according to a conference transcript.
Luke Allan, 13, closes his eyes as he gets a coronavirus vaccination at the Fairfax Government Center vaccination clinic in Fairfax, Virginia on May 13, 2021. (Andrew Caballero-Reynolds/AFP via Getty Images)
“We would expect to have similar data for children between the ages of 6 months and 5 years old that we would file with the FDA, I’ll call it, in the weeks shortly thereafter the filing of the data for the 5 to the 11 year-olds,” he continued.
D’Amelio said he expect the timeline to run smoothly “assuming all of the data is positive.”
The FDA approved Pfizer’s coronavirus vaccine in late August to be given to those aged 16 and older. The decision was reportedly made based on a study involving more than 44,000 people for six months, with the data showing the vaccine to be 91 percent effective in preventing infection, per reports.
Pfizer’s vaccine for those ages 12-15 still operates under emergency use in the United States. However, both the BioNTech/Pfizer and the Moderna vaccines are authorized by the European Medicines Agency for children 12 years of age and above.