FDA grants full approval to Pfizer’s COVID-19 shot, now known as ‘Comirnaty’

By: and - August 23, 2021 3:14 pm

President Joe Biden participates in a tour of the Pfizer manufacturing facility Friday, Feb. 19, 2021, in Kalamazoo, Michigan. | Official White House Photo by Adam Schultz via Flickr Public Domain

WASHINGTON — The U.S. has its first fully approved vaccine against COVID-19, with federal health officials announcing Monday the approval of Pfizer-BioNTech’s two-dose vaccine.

The green light from the U.S. Food and Drug Administration (FDA) to move Pfizer’s vaccine from emergency use to full approval is a milestone in the national pandemic response, and one that comes as the country battles another surge in infections and hospitalizations due to the delta variant.

The Pfizer vaccine is the only one of the three shots being used under an emergency authorization so far to gain the FDA’s full approval. Moderna also has submitted an application for full approval, while Johnson & Johnson has said it will do so for its one-dose shot by the end of the year.

The approval represents a lightning-speed process at the FDA, which condensed a review process that typically would take roughly eight months in just three months.

As they sought to conduct that approval at a much faster pace due to the pandemic, public health officials also attempted not to undermine confidence among those who have said they were waiting to see the agency give a full sign-off before getting a jab.

“The moment you’ve been waiting for is here,” President Joe Biden urged Americans during a press conference Monday afternoon. “It’s time for you to go get your vaccination, and get it today.”

In February, Biden toured Pfizer’s Portage facility alongside Gov. Gretchen Whitmer, who noted the vaccine is “manufactured right here in Michigan” in a statement praising the FDA’s move and urging more people to get the shot.

“The FDA-approved Pfizer vaccine has already saved countless lives in Michigan and around the world, so if you have already gotten your shots, thank you for doing your part to keep yourself, your family, and your community safe,” she said. “If you still have not, I hope today’s announcement encourages you to get your FDA-approved vaccine. Speak to your doctor or pharmacist if you have more questions and get your free shot soon. The FDA-approved Pfizer vaccine can protect you against COVID-19 and keep you out of the hospital if you get sick. If we all do our part to protect ourselves and the people we love from COVID, we can continue our economic jumpstart and usher in a new era of prosperity for our great state.”

The vaccine’s full approval also may mean more Americans will be required to receive a vaccine in order to attend school, go to work, go out to eat, or attend concerts and other large-group events.

Members of the military are the latest to be subject to a vaccine mandate. Pentagon officials said Monday that a timeline for the new requirement is under discussion.

Gov. Gretchen Whitmer takes the Pfizer vaccination at Ford Field | Ken Coleman photo

Pfizer shot to be marketed as Comirnaty

The Pfizer vaccine was the first of the three current COVID-19 shots to receive emergency approval in mid-December. Initially authorized for those 16 and older, that authorization was expanded in May to include shots for those 12 through 15 years of age.

Monday’s approval changes the status for the shot’s use in those 16 years and older. While the vaccine will now have a new brand name — Comirnaty — nothing about the vaccine formula itself has changed.

The process involved significant data reviews, examining hundreds of thousands of pages of information from the clinical trials and visits to sites where the vaccine was studied and produced. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, told reporters that more than half of the clinical trial participants have been tracked for any safety concerns for at least four months, and 12,000 have been followed for six months.

The full approval does not yet extend to vaccines for those between 12 and 15 years old, who can still receive Pfizer shots through the emergency-use authorization.

Pfizer also is expected to apply this fall for using the vaccine in those under age 12, who are not yet eligible for any of the COVID-19 vaccines.

Federal regulators also have approved a third booster dose of the Pfizer shot for those who are immunocompromised. Additional boosters are likely to be approved for the broader population, beginning eight months after a second dose, but regulators at the FDA and Centers for Disease Control and Prevention have not yet set dates for approving those boosters.

Approval effect on vaccination rate

Nationally, vaccination rates, which had lagged since a spring peak, have been rising again, with 62% of those over age 18 now fully vaccinated. Six million shots have been administered in the last seven days, marking the highest seven-day total in a month and a half, Biden said Monday.

Those rising numbers come as the delta variant has wreaked havoc across the country, filling hospital beds and causing a rise in pediatric admissions due to COVID-19. The vast majority of those hospital admissions are among Americans who have not yet been vaccinated.

Among those who have not received a COVID-19 vaccine, three in 10 said in a June tracking survey by Kaiser Family Foundation that they would be more likely to get vaccinated if one of the vaccines authorized for emergency use were to receive full approval from the FDA.

The National Governors Association praised the FDA’s approval in a statement Monday, calling it “another tool that will help combat hesitancy.”

“We have heard from many of our residents as we have traveled across our states and territories, held town halls, and met with residents, who are hesitant to get vaccinated because they are awaiting full approval of the vaccines,” said Govs. Asa Hutchinson of Arkansas and Phil Murphy of New Jersey, who lead the NGA, adding that the approval helps to address some objections and safety concerns.

Thousands of doses of the Pfizer vaccine were administered at the Ford Field COVID-19 vaccination site in Detroit | Laina G. Stebbins

More vax mandates to come?

As he urged unvaccinated Americans to get their shot, Biden on Monday also praised governors, mayors and companies that have required their employees and patrons to be vaccinated against COVID-19.

The full approval of Pfizer’s shot may spur an uptick in vaccine requirements in the public and private sector, which in turn may help drive up vaccination rates, said Dr. Mark McClellan, a Duke University health policy expert and former FDA commissioner.

“While we already had a number of businesses, schools, entertainment venues requiring vaccination or proof of a negative test or something like that, those numbers are going to go up significantly,” McClellan said. “That probably is going to drive the bigger impact of the full approval on vaccination rates in this country, probably even more than the remaining people who are having doubts and potentially willing to be convinced.”

Michigan does not have a statewide vaccine mandate, but several employers have issued their own. House Republicans held a hearing last week on legislation that would ban employers from requiring vaccines and allow employees to sue for harm. Whitmer said at a Lansing event Monday she would veto such legislation.

However, unlike last year, Michigan does not have a statewide school mask mandate. Dr. Joneigh Khaldun, the state’s chief medical executive and chief deputy health director, said during a Wednesday press conference that she has urged Whitmer and Department of Health and Human Services (DHHS) Director Elizabeth Hertel to implement a statewide mask mandate for schools. Whitmer said Monday she supports schools making the call to mandate masks.

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Laura Olson
Laura Olson

Laura covers the nation's capital as a senior reporter for States Newsroom, a network of nonprofit outlets that includes Michigan Advance. Her areas of coverage include politics and policy, lobbying, elections, and campaign finance.

Susan J. Demas

Susan J. Demas is a 21-year journalism veteran and one of the state’s foremost experts on Michigan politics, appearing on MSNBC, CNN, NPR and WKAR-TV’s “Off the Record.” In addition to serving as Editor-in-Chief, she is the Advance’s chief columnist, writing on women, LGBTQs, the state budget, the economy and more. Most recently, she served as Vice President of Farough & Associates, Michigan’s premier political communications firm. For almost five years, Susan was the Editor and Publisher of Inside Michigan Politics, the most-cited political newsletter in the state. Susan’s award-winning political analysis has run in more than 80 national, international and regional media outlets, including the Guardian U.K., NBC News, the New York Times, the Detroit News and MLive. She is the only Michigan journalist to be named to the Washington Post’s list of “Best Political Reporters,” the Huffington Post’s list of “Best Political Tweeters” and the Washington Post’s list of “Best Political Bloggers.” Susan was the recipient of a prestigious Knight Foundation fellowship in nonprofits and politics. She served as Deputy Editor for MIRS News and helped launch the Michigan Truth Squad, the Center for Michigan’s fact-checking project. She started her journalism career reporting on the Iowa caucuses for The (Cedar Rapids) Gazette. Susan has hiked over 4,000 solo miles across four continents and climbed more than 70 mountains. She also enjoys dragging her husband and two teenagers along, even if no one else wants to sleep in a tent anymore.