The Food and Drug Administration on Monday announced that it had approved Pfizer and BioNTech’s Covid-19 vaccine, opening the door to more widespread vaccine mandates as schools and universities begin their academic years. The approval comes eight months after the FDA issued Pfizer its first emergency-use authorization for a Covid-19 vaccine on Dec. 11. Since then, more than 204 million doses of the vaccine have been administered in the U.S. alone. On Monday, the FDA’s acting commissioner, Dr. Janet Woodcock, said the approval should boost public confidence in the Pfizer vaccine.
“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,” Woodcock said in a statement.
The agency approved the vaccine in people aged 16 and older. Emergency-use authorization remains in place for those aged 12 to 15. A third dose for immunocompromised individuals is also still authorized, but not yet approved. “I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity,” Pfizer’s CEO, Albert Bourla, said in a statement after the approval was announced. Pfizer shares were up 3.9% Monday morning, while BioNTech’s American depositary receipt was up 9.9%. Moderna (MRNA) shares also climbed 5.5%. Emergency-use authorization is short of the full approval that most vaccines and therapeutics must receive before they can be administered to patients. The FDA and Pfizer have been working toward full approval for months. Neither of the other two Covid-19 vaccines to be authorized in the U.S., from Moderna and Johnson & Johnson (JNJ), has received full approval. Approval of the Pfizer vaccine won’t change much for the hundred million people in the U.S. who have already received it. It could, however, ease the way for businesses and institutions seeking to require vaccination as a condition of returning to in-person work or school. Speaking on CNN’s State of the Union on Sunday, Surgeon General Dr. Vivek Murthy said full approval could allow for more vaccine mandates. “For businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think that this move from the FDA, when it comes, will actually help them to move forward with those kinds of plans,” Murthy said. While some vaccine mandates have already been put in place, others have waited on full FDA approval. The Department of Defense, the world’s largest employer, has said it plans to require Covid-19 vaccines for members of the military once the FDA approval is in place. Though there have been legal challenges to vaccine mandates, they have been met with little success in the courts. The Supreme Court in mid-August declined to intercede in a challenge brought by students at Indiana University. The long-term outlook for the pandemic is making a long-lasting and robust market for Covid-19 vaccine boosters look increasingly likely, a bullish sign for the current leading Covid-19 vaccine makers.