BREAKING NEWS: FDA will decide on whether to fully approve Pfizer’s COVID-19 vaccine by January 2022
- The U.S. Food and Drug Administration (FDA) goal data to decide on full approval of Pfizer-BioNTech’s COVID-19 vaccine for ages 16 and older is January 2022
- Fully approval requires at least six month of follow-up data rather than the two months required for emergency use authorization
- If approved, Pfizer-BioNTech’s shot will be the first fully approved coronavirus vaccine in America
- Health experts hope full approval will boost COVID-19 vaccine uptake with daily shots falling below one million per day
The U.S. Food and Drug Administration (FDA) will decide on full approval of Pfizer-BioNTech’s COVID-19 vaccine for those aged 16 and older no later than early next year.
Currently, the two-dose shot is only authorized for emergency use in Americans aged 12 and up.
However, the FDA granted Priority Review to Pfizer-BioNTech’s application, meaning all overall attention and resources are directed at reviewing data on the vaccine.
According to a press release from the two companies on Friday, the federal health agency’s goal date for a decision is by January 2022.
If approved, the vaccine will be the first fully approved COVID-19 shot and could help ease vaccine hesitancy among some Americans due to the longer-term data required for full FDA approval.
The U.S. Food and Drug Administration (FDA) goal data to decide on full approval of Pfizer-BioNTech’s COVID-19 vaccine for ages 16 and older is January 2022 (file image)
Fully approval requires at least six month of follow-up data rather than the two months required for emergency use authorization. Pictured: Simon Huizar, 13, receives a first dose of the Pfizer COVID-19 in Los Angeles, May 2021
Because Pfizer’s vaccine is currently approved for use on an emergency basis, it is still considered somewhat experimental despite data showing it safe and effective.
Additionally, emergency use authorization requires less clinical trial data, with the FDA only requiring two months of follow-up before approving the shot for those 16 and older in December 2020.
The designation is also intended to be temporary.
If and when the shot is fully approved, companies and schools may feel more comfortable requiring employees and students to get it.
The decision would also allow the vaccine makers to market their shots directly to the general public.
According to the press release, Pfizer and BioNTech completed the rolling submission of data to the FDA in May 2021.
It includes data from the Phase III trial completed last year and six months of follow-up data rather than two months.
Although the shot is currently approved for use in teenagers and adults, the full approval would only be for those aged 16 and older because emergency authorization for Americans aged 12 to 15 only occurred in May.
The companies plan to apply for full approval in teens as well, but only after six months of follow-up data is available, the press release states.
Health experts are hopeful that full FDA approval will boost COVID-19 vaccine uptake and ease vaccine hesitancy.
Health experts hope full approval will boost COVID-19 vaccine uptake with daily shots falling below one million per day
‘Many people who are lower risk understandably ask if the benefits justify taking a medication that has not received the full and traditional FDA stamp of approval,’ wrote former U.S. Surgeon General Dr Jerome Adams in an op-ed for The Washington Post in April 2021.
‘Further studies…will help show skeptics that the authorized COVID vaccines are safe.’
Moderna Inc has also filed for full approval from FDA for its COVID-19 vaccine, announcing the news on June 1.
The Cambridge, Massachusetts-based company said it will continue to submit data to the FDA on a rolling basis over the coming weeks with a request for a priority review.
The decision to fully approve Moderna’s vaccine will likely come after the Pfizer decision due to Moderna submitting its application later.