The U.S. Food and Drug Administration announced its decision to fully approve the Pfizer vaccine for Americans 16 and older. The vaccine remains under emergency use authorization for teens and tweens ages 12-15 and for a third dose for people who are immunocompromised.
This vaccine — largely produced and distributed from a facility in Portage, Michigan — is one of three used in the United States to combat COVID-19, but it's the first to move from emergency authorization to formal approval.
"This is a pivotal moment for our country in the fight against the pandemic," said Acting FDA Commissioner Dr. Janet Woodcock. "As the first FDA approved COVID-19 vaccine, the public can be confident that this vaccine meets the FDA gold standards for safety, effectiveness, and manufacturing quality that we require for an approved product.
"We're acutely aware that vaccines are one of our greatest weapons against the virus and we know that vaccine approval holds the promise of altering the course of the pandemic in the United States. And that for some, an FDA approved COVID vaccine may instill in them the confidence to go and get vaccinated.
"Working around the clock, FDA staff were able to complete the evaluation of this biologics license application in just over three months. This is an unprecedented timeline given the volume of review and the meticulous manner in which it was done, but we want to underscore that our efforts to move as quickly as possible have in no way sacrificed scientific standards or the integrity of our process. Approving the vaccine as rapidly as possible, while ensuring a rigorous and thorough review, has been our top priority."
The Pfizer vaccine, to be marketed as Comirnaty, is given in two doses, spaced three weeks apart.
The FDA evaluated approximately 22,000 people who received the vaccine versus the impact of COVID-19 on 22,000 who did not. According to this trial, the Pfizer vaccine was 91 percent effective in preventing COVID-19.
This mirrors the results of other studies that have indicated for months that the vaccines are safe and effective. However, breakthrough cases, general mistrust and other factors have prevented a sizable minority of Michigan's population from getting vaccinated.
"With this announcement today by the FDA, it's a huge opportunity," said Kerry Ebersole Singh, director of the Protect Michigan Commission, which was created in January to work within the state health department to educate the public about COVID-19 vaccines and help overcome vaccine hesitancy.
"Some, through our public opinion research, have indicated that full approval from the FDA would be a mark towards moving them to get vaccinated. So for some that have been undecided that were uncertain still with the emergency authorization, ... that full approval is going to be a motivator."
Nearly 5.3 million Michiganders ages 16 and older, or 65 percent of that population, have gotten at least one dose of COVID-19 vaccine as of Friday, according to the state's vaccine dashboard.
About 402,600 more state residents ages 16 and older would need a first dose of the vaccine to hit the 70 percent goal Gov. Gretchen Whitmer put in place earlier this year.
Even before full FDA authorization, nearly half a dozen health systems in Michigan had announced vaccine mandates for workers.
But two of the state's largest — Beaumont Health and Spectrum Health — said they would wait for full authorization to require vaccines for their 64,000 employees. Details from those health systems about the timing for when workers, volunteers and contractors will have to get vaccinated or lose their jobs have yet to be released.
The vaccine mandates at several health systems across the state have sparked protests among some who say workers should have a choice about whether to take the shots.
Dr. Peter Marks, the director of the FDA Center for Biologics Evaluation and Research, said Monday that misinformation about the vaccines threatens the nation's success in ending the coronavirus pandemic.
"One of the biggest challenges that we still face in getting the public vaccinated ... (is) the overwhelming amount of information that's been circulating about COVID-19 and the vaccines," he said. "We have heard false claims that COVID-19 vaccines cause infertility, contain microchips and cause COVID-19. And worse, we've heard false claims that thousands of people have died from the vaccine.
"Let me be clear: These claims are simply not true. Getting a COVID-19 vaccine can save your life. ... We know that for some people, FDA approval of a COVID-19 vaccine may give them the competence to get vaccinated.
"By following our rigorous processes to evaluate this application, we hope those who have waited until now to make the choice to protect themselves and ... thereby also help protect their community by reducing the spread of COVID-19 will go and get vaccinated."
While the vaccine is fully authorized now for people 16 and older, and remains under an EUA for children ages 12-15, Woodcock said there's not enough information yet about the safety and efficacy of the vaccine for children younger than age 12.
"We don't have the proper dose and we don't have the safety data, nor do we have all the efficacy data," Woodcock said, to use the vaccines in younger children.
"They are not just small adults, and we've learned that time and time again. And so we really would have to have the data and the appropriate dose before recommending that that (younger) children be vaccinated."
It's unclear how soon an emergency use authorization might be consider for children younger than 12, Marks said, as clinical trials in kids remain ongoing.
"The agency has to wait for the company to submit the data from those trials so that we have a good safety data set because we certainly want to make sure that we get it right in the children ages 5-11, and then even in younger children after that," he said.
"And so we will, obviously, move swiftly on once those data are submitted, but first, the trials have to be finished ... and then the data need to be submitted to us."
The American Medical Association lauded the full authorization of the vaccine, calling it a "major step forward in the worldwide effort to end this pandemic."
"With millions of data points on the vaccine's safety and efficacy over nearly nine months of vaccinations, every 'i' is dotted and every 't' is crossed. This vaccine is safe, it prevents severe COVID-19, hospitalization, and deaths, and it will save your life," the association said in a statement.
"According to recent polling, 30 percent of unvaccinated people said they were waiting for vaccines to receive full approval before getting vaccinated. We are there now; this vaccine is fully approved. If uncertainty was holding you back, now is the time to act. And if you still have questions about the vaccines or about COVID-19, please consult your health care professional."
The other two coronavirus vaccines now in use in the U.S., Moderna and Johnson & Johnson, remain under emergency authorization. Moderna has applied for full authorization of its COVID-19 vaccine to the FDA. Johnson & Johnson has yet to submit its application for full FDA approval.
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