Pfizer-BioNTech submit COVID-19 vaccine data to FDA for kids 5-11
Companies expect to request emergency approval for the shot in kids ages 5 to 11 in coming weeks
Dr. Lahita on Pfizer vaccine for kids, booster shots
Dr. Bob Lahita on the Pfizer vaccine for children and Biden's plans for booster shots, arguing the U.S. needs one spokesperson to discuss COVID to stump confusion regarding the virus.
Pfizer-BioNTech submitted clinical trial data from a COVID-19 vaccine study among kids ages 5-11 to the Food and Drug Administration (FDA), the companies announced Tuesday. A request for emergency approval is anticipated to follow in the coming weeks.
Trial data included findings released last week among 2,268 participants ages 5-11, which suggested the smaller dose shot was safe, well tolerated and resulted in neutralizing antibody responses.
CLICK HERE TO FIND A COVID-19 VACCINE NEAR YOU
"It's official: We have submitted initial data from the pivotal trial of our COVID-19 vaccine in children 5 to under 12 years of age to the @US_FDA," Pfizer CEO Albert Bourla wrote in a Tweet on Tuesday.
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| PFE | PFIZER INC. | 25.27 | -0.98 | -3.75% |
| BNTX | BIONTECH SE | 86.71 | -1.38 | -1.57% |
CLICK HERE FOR FULL CORONAVIRUS COVERAGE
"These data have been shared with the FDA for the Agency’s initial review," reads a company release posted Tuesday. Pfizer-BioNTech also intend to submit the data to other regulatory authorities, including the European Medicines Agency (EMA).
Meanwhile, trial results on younger age groups, like children ages 6 months to under 5 years, are expected by the fourth quarter. The companies also plan to submit data from the late-stage trial to a peer-reviewed publication.