FDA grants full approval of Pfizer COVID-19 vaccine
WASHINGTON D.C. – The Food and Drug Administration on Monday granted full approval of the Pfizer COVID-19 vaccine, becoming the first COVID-19 vaccine to transition from emergency authorization to full FDA approval.
The approval comes in a week prior to federal health officials’ estimates that the agency would complete its review by Labor Day.
We’re told the full approval indicates that Pfizer has shown enough effectiveness and safety data to meet the stringent Biologics License Application requirements, which includes at least six months of safety data from a majority of the volunteers in a large, final-stage clinical trial.
Pfizer’s full and formal approval will now pave the way for further vaccine mandates in the public and private sector, just like existing mandates for other FDA-approved vaccines.
Some businesses and state leaders have held off, signaling that they’d wait for full approval before imposing tighter requirements. Federal, state, and local health officials have also expressed optimism that full approval will help dissolve some of the hesitancy around taking a vaccine that had, until now, only been authorized for emergency use.
Maryland Governor Larry Hogan also issued the following statement on the FDA approval of the Pfizer vaccine:
“We want to thank federal officials for authorizing full approval of the Pfizer vaccine, which is something we have been pushing for over the last several weeks. For people who are still hesitant about getting the vaccine, this is an assurance that it has met the most rigorous standards for safety and effectiveness. While this is an important step, full approval of the Moderna and Johnson & Johnson vaccines is also vital to our efforts, and there are still a number of other areas where swift action is needed at the federal level to maximize our vaccination campaign.”
“Federal officials must make booster shots available immediately for seniors and vulnerable populations. The State of Maryland is already mobilizing for the utilization of boosters, and we cannot afford to wait until the fall to protect those we know are most vulnerable.
“We also continue to call on the federal government to expedite approval so that our 5- to 11-year-olds can begin receiving COVID-19 vaccines. Getting our children vaccinated is critical to giving parents greater peace of mind, but we are being told approval is still months away. Any further delay on boosters and expanding vaccine access could be devastating to our continued recovery from COVID-19. We look forward to working with the Biden administration on all of these issues.”
