- The FDA gave full approval to Pfizer-BioNTech for its coronavirus vaccine on Monday
- The move may help convince vaccine hesitant Americans to get the shot but also lead to more mandates
The U.S. Food and Drug Administration (FDA) granted full approval to Pfizer-BioNTech’s coronavirus vaccine for those aged 16 and older on Monday.
The two-dose immunization was the first to receive emergency use authorization from federal regulators in December 2020 and will now be first to be licensed.
Full approval by the FDA could push more Americans to get the COVID-19 vaccine because it might reduce their fears about the safety of the shot.
It may also lead to more vaccine mandates with businesses feeling more comfortable requiring workers to get a jab that has full authorization.
Pfizer said on Monday the vaccine will continue to be available for 12-to-15-year-olds and as third doses for immunocompromised people under emergency use only.
‘The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,’ acting FDA commissioner Dr Janet Woodcock said in a statement.
‘While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.
‘Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.’
Prior to Monday, Pfizer’s vaccine was only approved for use on an emergency basis, meaning it was considered somewhat experimental despite data showing it is safe and effective.
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 last year compared to six months for full approval.
The designation is also intended to be temporary.
With full approval, companies and schools may feel more comfortable requiring employees and students to get it.
‘If vaccines are fully authorized, that would take that excuse [for not getting vaccinated] off the table,’ Dr William Schaffner, a professor of preventive medicine and infectious diseases at the Vanderbilt University Medical Center, toldin an interview last month.
‘If fully licensed, I think that movement of [vaccine] mandates would accelerate and generate lots of vaccinations.’
This is a breaking news story and will be updated.