The belief that COVID vaccines are more dangerous than the virus itself is one of the primary culprits behind the daunting number of people who remain resistant to the vaccine despite surging case numbers. In hopes of assuaging fears surrounding the vaccines, the Biden administration is pushing for the expedition of the vaccines’ full approval by the Food and Drug Administration. Full approval of the COVID vaccines could come as soon as “month’s end” if the Biden administration gets its way.
“I hope—I don’t predict—I hope that it will be within the next few weeks. I hope it’s within the month of August,” Dr. Anthony Fauci, the government’s leading infectious disease expert, said on NBC’s Meet the Press. “If that’s the case, you’re going to see the empowerment of local enterprises, giving mandates that could be colleges, universities, places of business, a whole variety and I strongly support that. The time has come … We’ve got to go the extra step to get people vaccinated.”
The primary perk of getting the COVID vaccines fully approved by the FDA is convincing the unvaccinated that the shots are actually safe. According to a survey conducted by the Kaiser Family Foundation in June, three in 10 unvaccinated adults say they are more likely to get jabbed once one of the vaccines is granted full FDA approval.
“People are going to see full approval, and they are going to feel much more confident in taking the vaccine,” Dr. Robert Murphy, executive director for the Institute of Global Health at Northwestern University’s Feinberg School of Medicine, told NBC News.
Murphy noted that a huge reason for people’s uncertainty over the safety of vaccines that have only been granted emergency use authorization (EUA) is the lack of understanding over what that really means.
“It does not mean it’s experimental. All the experimental work has been done,” he said.
Other medical experts, however, believe that even full approval won’t convince everyone, thanks to the vast amount of misinformation spurring vaccine hesitancy. The Kaiser survey seems to support this theory, noting that two-thirds of adults—most of whom are unvaccinated—believe that all three available vaccines are either already fully approved or are unsure of their approval status.
What is the difference between a vaccine that’s been granted emergency use authorization and one that’s fully approved by the FDA?
EUA and full approval both require safety studies in the early stages. These studies focus on a small test group of people and record potential side effects caused by the vaccine. Safe and proper dosage of the vaccine is also determined. After an effective dose amount is identified, larger studies are conducted.
Past this stage, the requirements for EUA and full FDA approval for COVID vaccines differ. For a vaccine to get EUA, the FDA requires at least 50% of the initial test group to be observed for a minimum of two months after completion of the full vaccination regimen, to monitor potential side effects.
In comparison, full FDA approval requires the observation period to be extended to a minimum of six months. Other requirements for full FDA approval reportedly include real-world data on a vaccine’s safety and effectiveness outside of clinical trials, as well as more detailed plans for manufacturing and inspection. These steps add a significant amount of time to the review process.
“Full FDA approval will likely apply initially to only the same age groups that were tested in the original emergency use authorization,” Associate Clinical Professor of Pharmacy Practice at University of Connecticut Jennifer Girotto explained in an article for The Conversation. “This means that the vaccine will likely be approved first for people ages 16 and up for Pfizer and 18 and up for Moderna. Rolling submission will allow approval of the vaccine for younger groups as more data becomes available.”
Dr. Paul Offit, a member of the FDA’s vaccine advisory committee and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said the FDA is currently “working around the clock” to get the COVID vaccines fully approved.
“I think from the standpoint of the public, it really shouldn’t matter,” Offit told CNN. “It’s been given to half of the American population. We have more than 300 million doses out there. This is far from experimental. We have a tremendous safety and efficacy portfolio on these vaccines—I mean, it’s more than most licensed products that are out there now.”
Full FDA approval may mean more vaccine mandates
Once the FDA issues a full approval for the COVID vaccines, a slew of vaccine mandates are likely to follow, Fauci told USA Today. Mandates are unlikely to happen at the federal level, but Fauci predicted that vaccine approval will galvanize various groups.
“Organizations, enterprises, universities, colleges that have been reluctant to mandate at the local level will feel much more confident,” Fauci said. “They can say: ‘If you want to come to this college or this university, you’ve got to get vaccinated. If you want to work in this plant, you have to get vaccinated. If you want to work in this enterprise, you’ve got to get vaccinated. If you want to work in this hospital, you’ve got to get vaccinated.'”
According to the U.S. Equal Employment Opportunity Commission, workplaces already have the legal authority to institute COVID-19 vaccine mandates. Anyone hoping to dispute these requirements may find it more challenging to do so once full approval is granted.