A Surge of Unvaccinated People May Get Their Shots Next Month. Here's Why.
An upcoming update from the FDA could help to change some Americans' minds.
When the COVID vaccines were authorized for emergency use by the U.S. Food and Drug Administration (FDA), tens of millions rejoiced and eagerly anticipated their turn to sit down for a shot. However, many others have remained skeptical of vaccines, in part because the shots hadn't yet received full approval from the agency. Some unvaccinated people claim they've been waiting for the FDA's official sign-off before moving forward with vaccination. Now, with full approval right around the corner, some experts are cautiously optimistic that a surge of vaccinations could follow—and that uptick could drastically change the course of the pandemic.
According to data from the Centers for Disease Control and Prevention (CDC), 69 percent of the eligible U.S. population has gotten one dose of the vaccine, with 59 percent fully vaccinated. While many unvaccinated people aren't likely to change their minds, others say they're waiting until the full FDA approval is announced.
As CNN reported, to qualify for emergency-use authorization (EUA), the vaccine companies submitted about three months' worth of clinical trial data, including at least two months of safety data on vaccinated participants. Full FDA approval, on the other hand, requires much more. One of the most significant differences between the EUA and full approval is that the latter will have even more data behind it, including safety and real-world effectiveness results from the past several months. Per CNN, the CDC has been tracking data from the more than 165 million vaccinated people in the U.S.
For people who are hesitant about the COVID vaccines, this glut of real-world data could help persuade them that the shots are safe and effective. "For some, getting a full FDA approval will help allay that fear. Even if it's just a relatively small number of people. Every little bit helps against this virus," David Dowdy, MD, an epidemiologist at Johns Hopkins Bloomberg School of Public Health, told CNN. Michael Wolf, PhD, Associate Vice Chair for Research, Department of Medicine, at Northwestern Medicine, told CNN that he expects full FDA approval would help get about 5 to 10 percent more people vaccinated.
A recent survey from the Kaiser Family Foundation found that 3 in 10 unvaccinated adults said they'd be more likely to get vaccinated if one of the vaccines received full approval. However, the foundation did note that a portion of the people surveyed hadn't realized that the vaccines weren't already fully approved, or they were unsure about it. These results suggest that full approval "is a proxy for general safety concerns."
We should know whether the FDA's decision will make an impact soon. Former FDA commissioner Scott Gottlieb, MD, recently told CNN that full approval could come next month. "I long felt that the FDA would approve the vaccine probably within a three- to four-month time frame from when the application was submitted. Those applications were submitted about two and a half, three months ago," Gottlieb said. "So I think that puts you on [an] end of August, September time frame in terms of when these are going to be approved."
Another FDA official told CNN that the agency is working as fast as they can to review the applications. According to reporting from The New York Times, officials familiar with the FDA's plan said that the agency's unofficial deadline for full approval is Labor Day. Whether that will lead to a surge in shots for the unvaccinated remains to be seen.