The Food and Drug Administration(FDA) fully approved Pfizer-BioNTech’s COVID vaccine for individuals 16 and older, adding a boost of legitimacy to the shot now that it has shed its emergency use designation.
While many localities and governments, such as New York state’s, have already required inoculation against the virus as a condition of employment, the Monday announcement is expected to persuade many more private industries and establishments to mandate the vaccine for staff, customers, and other personnel.
The agency’s decision comes amid a COVID rebound, triggered by the highly transmissible delta variant, that has undermined some of the public health gains of the last year, sending case numbers surging in many states.
For the millions of hesitant Americans who have abstained from the vaccine, many of whom reside in the South and Midwest, the Biden administration hopes the full approval status will convince them of its merit.
For the FDA’s final review, Pfizer said it submitted research from 44,000 clinical trial participants in United States, the European Union, Turkey, South Africa and South America, the New York Times reported. The data indicated an efficacy rate of 91 percent for the Pfizer vaccine, a decline from 95 percent efficacy rate from December when the FDA first authorized it for emergency administering.
Children ages twelve to 15 are eligible to receive the Pfizer vaccine only under emergency use qualification until Pfizer conducts the research necessary to earn the approval stamp for that young demographic, a process which could take months.
Over 92 million Americans, 54 percent of those fully vaccinated, have received Pfizer doses, while the majority of the other half took the Moderna shot.
The next regulatory hurdle pharmaceutical companies will need to overcome is full FDA approval for the booster shot, which the Biden administration signaled it plans to recommend to the fully vaccinated eight months after their initial vaccination, starting September 20th. The impetus for the booster is declining effectiveness in the original vaccine that has resulted in an wave of “breakthrough infections.”
Federal health officials told the Times that the efficacy of Pfizer-BioNTech and Moderna’s vaccines, which both employ mRNA medical technology, decline over time. Compounded with the spread of the highly infectious delta variant, the circumstances will likely demand a third shot to protect the fully vaccinated from infection.
Moderna’s bid for full approval is still under FDA review, while Johnson & Johnson is expected to enter its vaccine for consideration for approval in the coming weeks.