U.S. Medicines Regulator Will Decide Whether to Fully Approve the Pfizer Covid Vaccine by January 2022

The Food and Drug Administration (FDA) will decide on whether to fully approve the use of the Pfizer Covid vaccine in the U.S. for those aged 16 and over no later than January 2022, it has been announced. The vaccine is currently only authorised for emergency use in Americans aged 12 and over and has been given to millions of people across the world. The MailOnline has the story.

According to a press release from the [Pfizer and BioNTech] 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 shot and could help ease vaccine hesitancy among some Americans due to the longer-term data required for full FDA approval. 

As of Friday, more than 186.5 million shots of the vaccine have been administered in the U.S., according to data from the Centers for Disease Control and Prevention (CDC). 

Because Pfizer’s vaccine is currently approved for use on an emergency basis, it is still considered somewhat experimental despite data showing it is safe and effective.

Additionally, emergency use authorisation 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. …

Moderna Inc has also filed for full approval from FDA for its Covid vaccine, announcing the news on June 1st. …

The decision to fully approve Moderna’s vaccine will likely come after the Pfizer decision due to Moderna submitting its application later.   

Worth reading in full.

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