FDA Approval Did Little to Boost U.S. Vaccinations, Experts Explain Why Hesitancy Remains

Despite hopes that a full approval from the U.S. Food and Drug Administration (FDA) would drive unvaccinated Americans to finally get their shots, early data shows that the final step didn't result in a significant spike in vaccination rates.

In the 10 days following the official announcement from the FDA, the U.S. administered 8,848,828 vaccines, according to data from the U.S. Centers for Disease Control and Prevention.

Comparably, in the 10 days leading up to the announcement, 8,489,839 vaccines were administered across the nation, indicating that vaccinations only increased by four percent following the FDA's decision, an analysis by Newsweek found.

The analysis also showed that the number of first doses administered in the 10 days after the approval actually went down nine percent, compared to the first dose rate from 10 days prior to the announcement.

Many had anticipated that the final seal of approval from the regulatory agency would encourage more people to get vaccinated, especially since polling among unvaccinated Americans suggested that a full approval from the FDA could help vaccine skeptics overcome their hesitancy.

The White House's chief medical adviser, Dr. Anthony Fauci, had estimated that the announcement would convince as many as 20 percent of 90 million vaccine-eligible people in the U.S. who are still unvaccinated to sign up.

A Kaiser Family Foundation survey from June also showed that roughly 30 percent of unvaccinated adults said a full approval would make them more likely to get vaccinated.

These projections forecasted that roughly 18 million for Fauci, and up to 27 million for the Kaiser survey, would get vaccinated after August 23, when the FDA announced that the Pfizer vaccine "meets the high standards for safety, effectiveness, and manufacturing quality" required by the agency.

However, early figures show that the number is barely half of what was predicted.

Vaccine Hesitancy Unvaccinated FDA Approval
"Those that are against the idea of getting vaccinated just shift their reasoning to something else," Dr. Virk told Newsweek. Above, protesters hold signs as they demonstrate during a "No Vaccine Passport Rally" in Santa Monica, California, on August 21, 2021. Ringo Chiu/AFP

Dr. Robert Blendon, a professor of health policy and political analysis at Harvard University, told Newsweek that the discrepancy is largely due to the way polls on vaccine hesitancy are conducted.

Because polls will ask respondents if they're "definitely" going to do something or if they're "somewhat more likely to," findings may represent a larger population than those who would carry out those behaviors in real life.

"It turns out a lot of the 'somewhat more likely' don't end up doing what they say they're going to," Blendon said.

The slight uptick in vaccinations since the FDA's approval—which is much closer to the 10 percent of people who said they would "definitely" sign up to get vaccinated pending the approval—is much more in line with what physicians had predicted.

"I kind of anticipated that we would have a slight increase, but I really was not surprised that we didn't get this big, big spike," Dr. Abinash Virk, an infectious disease expert at the Mayo Clinic, told Newsweek.

Virk said that while many unvaccinated people may have cited a lack of FDA approval as a reason for their decision, the approval could have been one of a multitude of reasons that people have. By itself, the announcement may not have been enough to convince some people to finally get their shots.

"It's really kind of multiple reasons that people seem to have. We all were hoping that having an FDA approval would make a difference, but the skeptical have remained skeptical," she said. "Unfortunately, [the FDA approval] helped, but it didn't totally change the landscape."

Virk added that for many skeptics, the reasoning behind not getting vaccinated will continue to shift even as more myths are debunked and more data proving the effectiveness and safety of the vaccines are published.

"Those that are against the idea of getting vaccinated just shift their reasoning to something else," she said.

"It's just the overall lack of belief that vaccines are needed," Virk added. "It may not necessarily be anti-vaccine, but there are a subset of people who feel like they don't need the vaccine and that we are overstating the benefit of the vaccine."

Vaccine Hesitancy FDA Approval Vaccinations Poll
"It turns out the core groups who don't get vaccinated are not very worried—either about COVID or Delta [variant]," Blendon told Newsweek. Above, a patient receives her booster dose of the Pfizer COVID-19 vaccine at the Southfield Pavilion on August 24, 2021, in Southfield, Michigan. Emily Elconin/Stringer

When it comes to vaccine hesitancy, the critical factor isn't what would encourage someone to get their shot, it's whether or not they're scared of the virus, Blendon argued.

"Most of [the polls] don't ask if you're very worried [about the virus], and it turns out the core groups who don't get vaccinated are not very worried—either about COVID or Delta [variant]," he said.

While the questioning in these polls makes logical sense if someone were afraid of getting COVID, Blendon said the questions don't work in reverse.

For example, if someone were fearful of an incoming hurricane, you could ask them what are they going to do to protect themselves.

"But if you just started out by saying what are you going to do about the hurricane when I'm not afraid of it, it's a different situation," Blendon explained.

He continued, "People have not paid much attention to the fact that the core groups who aren't getting vaccinated keeping telling pollsters, 'I'm not very worried,' and the pollsters just say 'No, here are the five things that are going to happen. [Which] would [cause] you take the vaccine?'"

He also noted that while many health experts have long-awaited the FDA's approval, many unvaccinated people do not trust the government and thus, don't hold agencies like the FDA in high regard.

While the full approval may not be driving up vaccinations as intensely as hoped, Blendon noted that vaccine rates are still increasing.

"There's a share that is really holding out [on vaccines], but I believe it's moving, and it's moving in the south. The FDA approval is just a small part of it. It has to do with the clinicians on TV telling you, 'I'm dealing with people in ICUs who told me they'd never get vaccinated and they're dying,'" he said.

Blendon said stories from local doctors working in intensive care are one of two key ways he believes vaccine hesitancy can be combatted.

The other method is to shift away from analyzing the number of new cases and towards the growing death toll and rising hospitalizations.

Blendon said in both situations it is important to evaluate the audience for messages against vaccine hesitancy.

"It's really focusing on risk of hospitalization and dying, and dealing with the fact that many of the people reluctant are anti-government. Some are very deeply religious and feel it conflicts with their religious feelings. You want to put [vaccines] into context that they can deal with it," Blendon said.