FDA will decide by January 2022 whether to fully approve Pfizer’s COVID-19 vaccine
- The U.S. Food and Drug Administration (FDA) target date to decide on full approval of Pfizer-BioNTech’s COVID-19 vaccine for ages 16 and older is January 2022
- Full approval requires at least six months of follow-up data instead of the two months required for emergency use authorization
- If approved, Pfizer-BioNTech injection will be America’s first fully approved coronavirus vaccine
- Health experts hope full approval will boost COVID-19 vaccine uptake, with daily shots less than a million a day
The U.S. Food and Drug Administration (FDA) will decide on full approval of Pfizer-BioNTech’s COVID-19 vaccine for individuals 16 years of age and older by early next year.
Currently, the two-dose injection is only approved for emergency use in Americans 12 years and older.
However, the FDA granted Priority Review to Pfizer-BioNTech’s application, meaning all attention and resources are focused on reviewing vaccine data.
According to an press release of the two companies on Friday, the federal health service’s target date for a decision is January 2022.
If approved, the vaccine will be the first fully approved COVID-19 shot and could help ease hesitation among some Americans because of the longer-term data needed for full FDA approval.
More than 186.5 million injections of the vaccine have been administered in the US as of Friday, according to data from the Centers for Disease Control and Prevention (CDC).
The U.S. Food and Drug Administration (FDA) will decide in January 2022 on full approval of Pfizer-BioNTech’s COVID-19 vaccine for ages 16 and older. Pictured:
Full approval requires at least six months of follow-up data instead of the two months required for emergency use authorization. Pictured: Respiratory therapist Robert Blas (left) administers Pfizer COVID-19 vaccine in Los Angeles, July 2021
Because Pfizer’s vaccine is currently approved for emergency use, it is still considered somewhat experimental, despite data showing that it is safe and effective.
In addition, emergency use authorization requires less clinical trial data, with the FDA requiring only two months of follow-up before the injection is approved for 16 years and older in December 2020.
The designation is also intended to be temporary.
If and when the shot is fully approved, businesses and schools may feel more comfortable requiring employees and students to get it.
The decision would also allow vaccine makers to market their shots directly to the general public.
According to the press release, Pfizer and BioNTech completed rolling data submissions to the FDA in May 2021.
It includes data from the Phase III study completed last year and six months of follow-up data instead of two months.
While the injection is currently approved for use in teens and adults, full approval would only apply to those ages 16 and older, as the emergency clearance for Americans ages 12 to 15 didn’t happen until May.
The companies plan to apply for full approval for teens as well, but only after six months of follow-up data is available, the press release said.
Health experts hope full FDA approval will boost uptake of the COVID-19 vaccine and reduce vaccine hesitation.
Health experts hope full approval will boost COVID-19 vaccine uptake, with daily shots less than a million a day
“Many lower-risk people understandably question whether the benefits justify taking a drug that has not received full and traditional FDA approval,” former U.S. Surgeon General Dr. Jerome Adams wrote in an op-ed for T.he Washington Post in April 2021.
“Further studies…will help skeptics demonstrate that the authorized COVID vaccines are safe.”
Moderna Inc has also filed for full FDA approval for its COVID-19 vaccine, announcing the news on June 1.
The Cambridge, Massachusetts-based company said it will continue to provide data to the FDA on a rolling basis in the coming weeks with a request for a priority review.
The decision to fully approve Moderna’s vaccine will likely come after Pfizer’s decision as Moderna is filing its application later.