Pfizer's COVID-19 Vaccine Gets Full Approval From the FDA
The approval may spur vaccine mandates and convince some holdouts that it's time to get vaccinated
The Pfizer-BioNTech vaccine was approved by the Food and Drug Administration on Monday, becoming the first COVID-19 vaccine to gain full approval. The shot had previously been administered under an emergency use authorization (EUA), which restricted its use to specific circumstances as part of a public health emergency.
“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” Janet Woodcock, MD, acting commissioner of the FDA, said in a statement. A June poll from the Kaiser Family Foundation found that 3 in 10 unvaccinated adults said they would be more likely to get vaccinated if one of the available vaccines received full FDA approval.
“The approval provides additional reassurance that the vaccine is safe and effective,” says Robert Atmar, MD, professor of medicine and infectious diseases at the Baylor College of Medicine in Houston and a member of the Baylor Vaccine Research Center. “I marvel that we have been able to reach this point so expeditiously since the disease was first recognized.”
What Full Approval Means
Though the vaccines had already undergone rigorous clinical trials before emergency authorization, the bar for full approval—also called licensure—is higher.
More Mandates May Be on the Way
“Full FDA approval strengthens the case for vaccination requirements as an important strategy to curb infection and prevent hospitalizations and deaths due to COVID-19,” Barbara D. Alexander, MD, president of the Infectious Diseases Society of America, said in a statement.
Though some employers, universities, and other institutions are already requiring COVID-19 vaccination, that trend may accelerate now that there is a vaccine that has been fully approved.
“Mandatory vaccination was always an option,” says Diane M. Juffras, professor of public law and government at the University of North Carolina Chapel Hill School of Government. “But many employers and universities were sensitive to the fears of employees and students and opted to encourage vaccination while waiting for full approval.”
Full approval may also make institutions that implement vaccine mandates less likely to face lawsuits. “The main argument in lawsuits challenging university and employer mandates was the legal argument that you cannot mandate a vaccine under an EUA. It is one of the few open questions on this, since university mandates and employer mandates have a long history,” says Dorit Reiss, a professor of law at UC Hastings College of the Law in San Francisco. “Licensure removes that argument, and would make challenging mandates much harder.”
Some states currently bar vaccine mandates, but in Texas, for example, the text of the executive order currently in place only prohibits public entities from requiring “any COVID-19 vaccine administered under an emergency use authorization.”
“This [approval] is really important,” says Poland, of the Mayo Clinic. “In the face of this highly contagious Delta variant . . . we either allow the virus to run rampant at the cost of tens of thousands to hundreds of thousands of deaths, millions of infections, and an unacceptable amount of illness, or we get to the point where we mandate vaccines and masks.”
Additional reporting by Catherine Roberts.
Editor’s Note: This story was updated to include a statement from the AAP.