The Food and Drug Administration fully approved the COVID-19 vaccine from Pfizer and German company BioNTech on Monday, a major step that could open the floodgates to mandates from local government, universities and employers.
Regulators licensed the two-dose vaccine for those aged 16 and older after a months-long review of piles of clinical data and manufacturing details, clearing the way for Pfizer to market the vaccines indefinitely.
It will be marketed under the name “Comirnaty.”
The Biden administration hopes the approval will spur vaccination among persons wary of the rollout under an emergency use authorization (EUA), a standard that determined the shots are safe and their benefits outweigh any risks amid the coronavirus crisis. The shots will still be available to those ages 12 to 15 under emergency approval.
“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. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,” acting FDA Commissioner Janet Woodcock said.
The decision comes as coronavirus infections are surging again because of the fast-moving delta variant. The U.S. is seeing just over 1,000 deaths per day. Some hospitals in Gulf Coast states are overflowing.
Approval also should lead to a sudden increase in the number of companies and venues willing to condition employment or entry on vaccination.
The University of Minnesota and other institutions said they would mandate the shots for employers and students once the FDA granted full approval.
United Airlines said its employees would have to get vaccinated within five weeks of approval, while the Defense Department is now poised to mandate the shots for more than 1 million active-duty troops.
In the Washington area, MedStar Health said it would mandate vaccinations for all of its employees once the vaccines were approved.
“There are universities and businesses that have been considering putting in vaccine requirements in order to create a safer, a workplace, a learning environment,” U.S. Surgeon General Vivek Murthy told “Fox News Sunday.” “I think this announcement from the FDA would likely encourage them and make them feel more comfortable in putting some requirements in place.”
The Justice Department and many lawyers say employers who required the shots under the emergency approval are on solid legal ground. Even so, some employers didn’t want to risk messy litigation or cause upheaval in their workplaces.
“They feel they’ll be on stronger legal ground to mandate vaccination in that setting. I also think that there are certain consumers that have been waiting for this milestone, waiting for the full approval and an indication that the FDA is done evaluating the data set to give them more confidence about using the vaccine,” former FDA Commissioner Scott Gottlieb, who is on Pfizer’s board of directors, said Sunday on CBS’s “Face the Nation.”
The COVID-19 vaccines were developed in record time under the Trump administration’s “Operation Warp Speed” last year, with shots for the coronavirus virus detected in December 2019 getting into American arms before Christmas 2020.
As the virus flares again, challenging President Biden, some critics worry that regulators didn’t do their due diligence ahead of Monday’s announcement.
Sen. Ron Johnson, Wisconsin Republican, said he is worried the approval served a political purpose of imposing and enforcing vaccine mandates that could scare away critical workers.
“The observational phases of FDA approval take time, because there is no substitute for time in detecting and determining possible long-term harm,” he wrote to major health agencies late Sunday. “Additionally, we are already experiencing a severe health care worker shortage. Frontline doctors and nurses that are contacting me are expressing grave concerns about vaccine mandates which will only exacerbate the shortage.”
He also found it odd that a panel of outside advisers — the Vaccines and Related Biological Products Advisory Committee (VRBPAC) — did not meet to discuss licensure, adverse reactions and deaths that might have been linked to vaccination prior to the approval.
Pfizer was the first COVID-19 vaccine-maker to receive emergency approval in December, followed by Moderna. Both versions use a messenger-RNA technology that teaches the body how to recognize and attack the spike protein of the virus.
“The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into — nor does it alter — an individual’s genetic material,” the FDA said, hoping to bust a common myth about the shots.
The formulation of the approved vaccine is the same as the one used under emergency status and will still be given in two doses, 21 days apart.
Moderna is seeking full approval from the FDA and is poised to follow Pfizer in receiving a license by this fall.
Johnson & Johnson makes a one-shot version of the vaccine but got a later start in its rollout and hasn’t applied for full approval yet.
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