Pfizer expects to file for full FDA approval of its COVID vaccine in May
(Gray News) - Pfizer plans to seek full approval of its COVID-19 vaccine with the U.S. Food and Drug Administration in the month of May, the company’s CEO said Tuesday.
The Pfizer-BioNTech vaccine currently has emergency authorization for use from the FDA.
CNN reported CEO Albert Bourla said during a first quarter earnings teleconference that the company expects to apply this month for full approval in people ages 16 and older.
Pfizer also expects to seek emergency authorization in September for children ages 2 to 11 to get the vaccine, the CEO said.
The company previously applied for its use in people ages 12 to 15. The Associated Press reported Monday that the FDA could extend its emergency use authorization for Pfizer’s vaccine to that age group as soon as next week.
It also has submitted information to the FDA that could allow the vaccine to be stored in standard refrigerators, Bourla said, potentially helping with distribution. The vaccine is now authorized to be stored in below freezing temperatures.
Pfizer in late March released preliminary results from a vaccine study of 2,260 U.S. volunteers ages 12 to 15, showing there were no cases of COVID-19 among fully vaccinated adolescents compared with 18 among those given dummy shots.
Kids had side effects similar to young adults, the company said. The main side effects are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety.
Pfizer isn’t the only company seeking to lower the age limit for its vaccine. Results also are expected by the middle of this year from a U.S. study of Moderna’s vaccine in 12- to 17-year-olds.
But in a sign that the findings were promising, the FDA already allowed both companies to begin U.S. studies in children 11 and younger, working their way to as young as 6 months old.
More than 131 million doses of Pfizer’s vaccine have already been administered in the U.S., where demand for vaccines among adults has dramatically slowed in recent weeks.
While younger people are at dramatically lower risk of serious side effects from COVID-19, they have made up a larger share of new virus cases as a majority of U.S. adults have been at least partially vaccinated and as higher-risk activities like indoor dining and contact sports have resumed in most of the country. Officials hope that extending vaccinations to teens will further accelerate the nation’s reduced virus caseload and allow schools to reopen with minimal disruptions this fall.
The U.S. has ordered at least 300 million doses of the Pfizer shot by the end of July, enough to protect 150 million people.
Copyright 2021 Gray Media Group, Inc. Associated Press contributed to the report. All rights reserved.