FDA grants full approval to Pfizer’s COVID shot, more vaccine mandates predicted

By: and - August 24, 2021 1:00 am

More Georgians who resisted getting vaccinated while waiting for shots to get full FDA approval are expected to get a jab now. And experts predict more employers will require workers to get a shot. Getty Images

The full federal approval of Pfizer-BioNTech’s two-dose vaccine marks a new chapter in the battle against COVID-19.

In Georgia, where vaccination rates are low and resistance is high, experts are hoping it will sway on-the-fence residents into taking their medicine and, if not, spur employers into requiring them to.

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

More than 60% of Americans have received at least one dose of the vaccine, and experts have long pointed to data that shows the shots are safe and effective. Still, the official thumbs-up is a significant piece of evidence to bolster that fact, said Dr. Isaac Chun-Hai Fung, associate professor of epidemiology at the Jiann-Ping Hsu College of Public Health at Georgia Southern University.

“With this new formal approval from the FDA, the public should have the same confidence as they do with existing vaccines that we have used for years against other diseases,” Fung said.

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 that typically would take roughly eight months into 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.”

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. Georgia is home to large military bases, including Fort Benning near Columbus and Fort Gordon near Augusta.

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.

Georgia’s vaccination rate has lagged behind the rest of the country with about 42% of the population currently fully vaccinated and about 50% with at least one dose, according to the state Department of Public Health.

Those 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.

We're really hopeful that the public will see this as a bit about safety from the FDA, and they will start to be vaccinated. Our hospital numbers are astronomical right now, and we've got to get some more people vaccinated so that, even if they do end up contracting COVID, they're not as much at risk for severe infection and being admitted.

– Georgia Hospital Association spokeswoman Anna Adams

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 association, adding that the approval helps to overcome some objections and safety concerns.

Georgia Gov. Brian Kemp also praised the action.

“As I stated in my letter to the @US_FDA on August 5th, it is my hope more Georgians will become comfortable getting vaccinated once the safe, effective vaccines have full federal approval,” Kemp said in a Tweet Monday.

“Today’s move by the @US_FDA to grant full approval of the Pfizer vaccine is a welcome step in the right direction, and I encourage them to take similar action with the two COVID-19 vaccines still under Emergency Use Authorization,” he added, urging unvaccinated Georgians to speak with a medical professional about getting a shot.

A sizeable chunk of the unvaccinated population could soon take Kemp’s advice, said former FDA commissioner Dr. Mark McClellan, who now directs the Duke-Margolis Center for Health Policy at Duke University, during a virtual press briefing Monday afternoon.

About 70% of Americans who are eligible for the vaccine have gotten at least one dose, McClellan said, leaving about 87 million eligible Americans who have not gotten the jab. According to recent surveys, about 30% of them — just over 26 million — said full approval would make a difference in their decision, McClellan added.

“For anybody who does have doubts, this should help overcome it,” he said. “We really aren’t seeing anything fundamentally new in the announcement today about the safety and effectiveness of the vaccine. We know it’s very effective. We know there are rare, temporary side effects but that the benefits do seem to clearly outweigh the risks.”

“I do think we now have very clear evidence that some of the misinformation out there – like the vaccine can cause fertility issues or can cause COVID or things like that – are just not there in the data. On the other hand, the effectiveness is,” he added.

For some Georgians, vaccines have become a cultural and liberty issue rather than a medical one.

Republican U.S. Rep. Marjorie Taylor Greene, a star of the far-right, has been temporarily banned from Twitter twice in recent months for posting misinformation about vaccines.

The prevalence of online conspiracy theories about the vaccine has some questioning whether the latest approval from the FDA will convince many of the true believers.

“My gut tells me that because a significant chunk of the people who are vaccine hesitant, a lot of them have other outlandish theories that they kind of trot out a lot,” said Duluth resident Ashley Chen. “So if someone’s kind of dabbling and trafficking in conspiracy theories, I don’t know what FDA rules are going to do. I just think they’re going to move the goalposts to rationalize something else, maybe how corrupt the FDA approval process was, how Joe Biden pushed it, it was faster than any FDA approval ever.”

Chen, who works in IT infrastructure, runs a pro-vaccine Facebook group with more than 9,000 members with his wife, Alicia. When vaccines were in short supply, it was a forum for helping people find doses, but now it’s more of a spot to share information about vaccines in Georgia, he said.

Chen said he’s skeptical that the news will cause another rush of people to the board.

“We’re taking a wait-and-see approach — which is ironic, because (the vaccine hesitant) are always saying that — but we’re taking a wait-and-see approach about FDA approval,” he said.

“I don’t know that FDA approval is going to drive new members to our group, but we’re always hopeful that people will join and educate themselves and avail themselves of a lot of the research and the resources that people post on our group,” he added.

Misinformation can arise at any time, and the best way to fight it is to build public trust in the scientific consensus, Fung said.

“What is important is that we continue to strengthen the public’s confidence in our institutions including the FDA, the (Centers for Disease Control and Prevention) and other agencies, federal, state and local, so they can have confidence in those agencies’ transparency and independence and that they are based on the science. Public trust in the medical and scientific professions is also important, because I believe that a lot of these conspiracy theories have their origins in members of the public who do not have high trust in these institutions or professions.”

More vaccine mandates to come?

Rather than convincing skeptical individuals to get the shot, the new approval could prompt businesses to require it.

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, McClellan said.

“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.”

Some major Georgia companies including Delta Air Lines and Cox Enterprises announced plans for vaccine requirements for at least some employees before the FDA’s decision.

Medical centers have been at the forefront of requiring immunizations, including major operations such as Piedmont Healthcare and WellStar Health System.

“A lot of the metro hospitals have been doing some form of a vaccine mandate, but they all look a little bit different,” said Georgia Hospital Association spokeswoman Anna Adams. “Some of them have some pretty lenient ways to avoid being vaccinated, religious exemptions, if you’re pregnant, and others are not so lenient, although they all do allow for patient or outpatient staff members to be notified prior to the mandate where they stand if they choose not to do it.”

Hospital emergency departments have been overrun with mostly unvaccinated patients. Of the 620 COVID-19 patients currently receiving care at WellStar facilities, 90% are unvaccinated, and the numbers of those in the intensive care unit or on ventilators are even higher.

“We’re really hopeful that the public will see this as a bit about safety from the FDA, and they will start to be vaccinated,” Adams said. “Our hospital numbers are astronomical right now, and we’ve got to get some more people vaccinated so that, even if they do end up contracting COVID, they’re not as much at risk for severe infection and being admitted.”

Still, medical centers with mandates have drawn protests, including from nurses who are skeptical about the shots. One surgical technician at WellStar reportedly lost her job after posting a video to social media comparing the upcoming mandate to the Holocaust.

Many vaccine hesitant hospital employees cited the lack of full authorization as their reason for fearing the needle, and Adams said she is hopeful the approval will help sway them.

“If we have a lot of staff decide to be vaccinated and we don’t have to have mandates, that would be the ideal,” she said.

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 as young as 12.

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 CDC have not yet set dates for approving those boosters.

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Ross Williams
Ross Williams

Before joining the Georgia Recorder, Ross Williams covered local and state government for the Marietta Daily Journal.Williams' reporting took him from City Hall to homeless camps, from the offices of business executives to the living rooms of grieving parents. His work earned recognition from the Georgia Associated Press Media Editors and the Georgia Press Association, including beat reporting, business writing and non-deadline reporting. A native of Cobb County, Williams holds a bachelor’s degree in English from Atlanta's Oglethorpe University and a master’s in journalism from Northwestern University.

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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 Georgia Recorder. Her areas of coverage include politics and policy, lobbying, elections, and campaign finance.

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