The Food and Drug Administration granted full approval Monday to the COVID-19 vaccine from Pfizer and German company BioNTech, a major step that will trigger mandates from local governments, universities and employers and might instill confidence in those leery of the emergency authorization last fall.
Regulators signed off on the two-dose vaccine for those 16 and older after a monthslong review of clinical data, real-world results and manufacturing inspections. It cleared the way for Pfizer to market the vaccine indefinitely under the name “Comirnaty.”
The Biden administration hopes the full approval will increase vaccination rates among people wary of the rollout under an emergency use authorization. The governmental standard determined that the shots were safe and their benefits outweighed the risks of coronavirus infection. The vaccines will still be available to children ages 12 to 15 under the emergency use authorization.
“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 agency announced its decision during another surge in coronavirus infections caused by the fast-moving delta variant. More than 1,000 people a day in the U.S. are dying from COVID-19. Some hospitals in Gulf Coast states are overflowing.
Dr. Woodcock said the FDA worked under “an unprecedented timeline, given the volume of the review and meticulousness with which it was done,” but she insisted that regulators did not sacrifice their standards.
Sen. Ron Johnson, Wisconsin Republican, said the process appeared rushed for political purposes and sidestepped outside advisers.
“Expediting the approval process for the COVID-19 vaccine appears to primarily serve the political goal of imposing and enforcing vaccine mandates,” Mr. Johnson said in an email to The Washington Times. “Our federal health agencies have not been forthright with the public about how these life-altering decisions have been made or what science and data they are based upon. This lack of transparency is unacceptable. The American people deserve full and accurate information so that they make up their own minds regarding vaccination.”
Still, FDA approval should lead to a sudden increase in the number of businesses and venues willing to condition employment or entry on vaccination.
The University of Minnesota and other institutions said they would mandate vaccines for employers and students once the FDA granted full approval.
MedStar Health, a large health care system in the Baltimore-Washington region, said in June that it would require its workforce to be vaccinated once the FDA granted full approval.
United Airlines said its employees would have to be vaccinated within five weeks of approval, and the Defense Department is poised to mandate the shots for more than 1 million active-duty troops.
State and city governments appeared to time their mandates to expected approval of the Pfizer shot. New York City announced Monday that all public education employees, including teachers and custodians, must receive at least one dose of a COVID-19 vaccine by Sept. 27. The decision follows similar mandates in Washington state, Chicago and Los Angeles.
As it stands, 51% of the U.S. population is fully vaccinated against COVID-19.
“The trajectory of the pandemic in the U.S. is almost entirely determined by the rates of vaccination in the U.S., so any increase in vaccine rates will be impactful,” said Dr. Amesh Adalja, a senior scholar for Johns Hopkins Center for Health Security.
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 last year under the Trump administration’s Operation Warp Speed. Shots to protect against the virus detected in December 2019 were going into American arms before Christmas 2020.
Pfizer was the first COVID-19 vaccine maker to receive emergency approval. Moderna followed. Both versions use 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,” said the FDA, hoping to debunk a common myth about the shots.
The messenger-RNA shots are over 90% effective in staving off severe illness and hospitalization from COVID-19, even in the face of the delta variant.
However, protection against infection appears to have weakened with the delta variant, and some fear that the immune response wanes eight months after the second dose.
A prominent study from the Centers for Disease Control and Prevention found the vaccines were 74.7% effective against infection among nursing home residents early in the program, from March to May, but effectiveness declined significantly to 53.1% in June and July when the delta variant became rampant.
A Yale Medicine study found the one-shot Johnson & Johnson vaccine, which uses adenovirus technology, is up to 71% effective against hospitalization from the delta variant and up to 95% effective against death.
With new challenges for the nation and President Biden’s response, some people were worried about regulators’ due diligence ahead of Monday’s announcement.
Mr. Johnson said the rush to full approval was politically motivated.
“The observational phases of FDA approval take time because there is no substitute for time in detecting and determining possible long-term harm,” the senator wrote to major health agencies late Sunday.
He found it odd that a panel of outside advisers, the Vaccines and Related Biological Products Advisory Committee, did not meet to discuss licensure, adverse reactions and deaths that might have been linked to vaccinations.
The FDA said it held a general meeting on the approval process for COVID-19 vaccines in October.
“FDA also has held meetings of the VRBPAC on all three COVID-19 vaccines authorized for emergency use, and does not believe a meeting is needed related to this biologics license application (BLA),” the agency said. “If the agency had any questions or concerns that required input from the advisory committee members, we would have scheduled a meeting to discuss.”
Other congressional Republicans focused on what approval will mean for uptake of the shots.
“This approval will build more confidence and trust in the vaccines, which are safe and highly effective at preventing severe illness, hospitalizations, and death from COVID-19,” Rep. Cathy McMorris Rodgers of Washington and other senior Republicans on the House Energy and Commerce Committee said. “Life under this pandemic has been full of fear — fear of the unknown, isolation, and uncertainty. What gave us hope from the beginning was the promise of American ingenuity and innovation. The COVID-19 vaccines, made possible by President Trump’s historic partnership with the private sector, turned that hope into a reality.”
Democratic allies of Mr. Biden pointed to stories of unvaccinated people expressing regret from their hospital beds.
“The FDA‘s full approval of a coronavirus vaccine shows Americans can have full confidence in the safety and effectiveness of a vaccine that has been painstakingly studied and reviewed,” said House Speaker Nancy Pelosi, California Democrat. “Every day, we are seeing the tragedy of unvaccinated Americans struggling to breathe in hospital beds, sending heartbreaking messages to their loved ones to get vaccinated before it’s too late. Getting vaccinated is not only the best way to protect ourselves, it is essential to protect those in our care, our schools, our workplaces and to stop the spread in our communities.”
Children younger than 12 are not eligible for COVID-19 vaccines. Dr. Woodcock warned against using the approved vaccine “off label” for young children and said clinical trials are underway to vaccinate children safely.
“We don’t have the proper dose, and we don’t have the safety data,” Dr. Woodcock said. “They are not just small adults.”
The formulation of the vaccine fully approved for ages 16 and older 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 and is expected to receive a license by this fall, though Dr. Peter Marks, the FDA‘s vaccine director, declined to estimate a timeline.
Johnson & Johnson got a later start in its rollout and has not yet applied for full approval.
The FDA, citing fears of waning immunity, is expected to review a separate plan in the coming weeks to provide booster shots of Pfizer and Moderna vaccines to people who received second doses eight months earlier.
Mr. Biden said his administration is ready to deliver boosters the week of Sept. 20, pending regulatory approval, though global health officials are upset that wealthy nations are providing third doses before much of the world gets initial shots.
The World Health Organization on Monday called for a two-month pause on booster shots. It said the vaccines are needed to reduce inequality around the globe and thwart the emergence of new variants.
• Shen Wu Tan contributed to this report.