The Food and Drug Administration (FDA) granted full approval to Pfizer-BioNTech’s COVID-19 vaccine for people 16 and older on Monday, making it the first of the three vaccines being administered in the United States to move beyond emergency use authorization.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic, FDA Commissioner, Janet Woodcock, said in a press release. “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.”
The decision will likely inspire new vaccination requirements from private businesses in Mississippi. Some hospitals in the state, such as the University of Mississippi Medical Center, announced vaccine requirements for employees and students before the FDA announcement. It is unlikely to move the needle at the state’s public colleges and universities, which have resisted such requirements.
Many hope that this approval will be the final step in pushing many across the country to get vaccinated. Scores of people in Mississippi have said that they were waiting on full FDA approval to get a COVID vaccine. It’s likely that some of those will stay true to their word, while others will move the goal posts for when they’d be comfortable getting the vaccine.
More than 1.2 million of the 2.45 million doses administered in Mississippi have been Pfizer doses.
The Pfizer vaccine has been available for people aged 16 and older under an emergency use authorization since Dec. 11. That authorization was issued after the vaccine was shown to be safe and effective in a randomized, controlled, and blinded clinical trial that is ongoing and includes thousands of individuals.
The FDA reviewed updated data from the clinical trial to support its approval decision, which included around 22,000 people who received the vaccine and 22,000 people who received a placebo, all 16 years of age and older. The results showed the vaccine to be 91% effective in preventing COVID-19, a slight decrease from the 95% efficacy rate shown by the data when the vaccine first received emergency authorization.
Pfizer’s clinical trials didn’t include children ages 12-15 at first, so the data needed to grant full approval for that age group is still months behind. The vaccine has been available for that age group under emergency use authorization since May 10. Data collected from the 2,264 trial participants in that age group showed it to be safe, and the side-effects they experienced were akin to those experienced by those ages 16-25. None of the children who were given the vaccine during the clinical trial contracted a symptomatic infection.
Though the FDA fast-tracked the Pfizer vaccine for approval, this does not mean the process was rushed, just that the agency prioritized it. More than half of the clinical trial participants were followed for at least six months after their second doses to monitor outcomes.