Calls Mount for Full FDA Approval of COVID-19 Vaccines

That the COVID-19 vaccines operate under emergency use authorization has been cited as the main reason for the vaccine hesitancy that could lead to a Delta variant surge in the United States.

That the COVID-19 vaccines had been granted approval under the Food and Drug Administration’s emergency use authorization (EAU) could most likely be the main reason for vaccine hesitancy among the public and even health care professionals, argue some medical experts. They want the FDA to grant full approval as soon as possible as a way of inducing the vaccine hesitant to get inoculated in the hope that that will stem the rising tide of the Delta variant, which has become the dominant strain in the United States.

Susan Wood, PhD, professor of Health Policy and of Environmental and Occupational Health at the George Washington University Milken Institute School of Public Health and the former Assistant Commissioner for Women’s Health at the FDA, recently pointed out to Infection Control Today®’s (ICT®’s) sister publication, Contagion®, that full approval of the vaccines would typically come after years of collecting real-world evidence.

Wood told Contagion® that “normally...the testing is slower, the back and forth between the FDA and companies is slower, the review process is slower, and it comes on the market in a graduated fashion.”

“Slower,” however, is the opposite of what should be the operative word in this situation, according to some medical experts. That word should be “faster.”

Eric Topol, MD, a professor of molecular medicine at Scripps Research, argues that granting the COVID-19 vaccines full FDA approval will be the best encouragement that the vaccine hesitant could get. “I don’t think there’s anything that can move the needle more in the U.S.,” Topol tells Politico.

Abby Capobianco, a spokeswoman for the FDA, said that the agency is moving as quickly as possible on the vaccine makers’ applications for full approval, but she would not tell Politico when that approval might happen.

According to the Kaiser Family Foundation (KFF), a quarter of those who are taking a wait-and-see approach to getting the vaccine—and, as ICT® reported, that includes many health care professionals—plan to get vaccinated within the next 3 months. “Notably, four in ten adults (37%) in the ‘wait-and-see’ group say they are likely to wait more than a year before getting vaccinated.”

Paul Sax, MD, the clinical director of the infectious disease clinic at Brigham and Women’s Hospital and a professor of medicine at Harvard Medical School, recently told ICT® that EUA approval for the COVID-19 vaccines should not be barrier to vaccine acceptance, and that the vaccines have proven their effectiveness. “I think that the fact that they’re not fully FDA approved right now is really more about paperwork and semantics than it is about what we can actually do,” says Sax.

Sax added that most hospitals and health care systems in the United States will make employment contingent on employees being fully vaccinated, though he conceded that “it might take the full FDA approval even though I’ve said in my mind that that’s not as important.”

According to the Kaiser Family Foundation (KFF), 3 in 10 unvaccinated adults—or about half of those in the wait-and-see group—say they they’re more likely to get vaccinated if the FDA grants full approval of the vaccines.

“However, this finding likely suggests that FDA approval is a proxy for general safety concerns, as two-thirds of adults (including a large majority of unvaccinated adults) either believe the vaccines currently available in the U.S. already have full approval from the FDA or are unsure whether they have full approval or are authorized for emergency use,” according to KFF.

Topol tells Politico that full FDA approval of the COVID-19 vaccines could bolster the efforts of businesses and schools and other establishments that want to mandate that their employees get fully vaccinated, or have to continue to wear masks and be subjected to frequent COVID-19 testing.

“Those people in that category that take the accommodation, they won’t last with the masks and the nasal swabs every couple days for very long,” Topol tells Politico.

Still, those who take the wait-and-see stand are not without their arguments. Earlier this month, the FDA revoked some of its EUA approvals for masks and respirators that had come to market during the first months of the pandemic, when such personal protective equipment were in dangerously short supply, as ICT® reported.

And as Contagion® reported, “while EUAs are designed to help people get immediate assistance, it’s not uncommon for tests or therapies granted EUAs to end up being ineffective. In the case of COVID-19 tests and treatments, the FDA issued EUAs it later revoked.”

In May 2020, companies could sell COVID-19 diagnostic tests for 15 days without EUAs. In that same month, the FDA issued 84 EUAs to applicant labs and businesses.

“But by February of 2021, enough data on testing had been collected for the FDA to reject 225 different antibody tests,” Contagion® reported. “Similarly, although the FDA had granted EUA status to the drug hydroxychloroquine in March of 2020, by June of 2020 it was clear from studies that the drug not only had no discernible benefit but might even be harmful to COVID-19 patients, and the EUA was withdrawn in June 2020.”