The first COVID-19 vaccine can finally drop its “emergency” status. The U.S. Food and Drug Administration on Monday issued full regulatory approval for the shot co-developed by Pfizer and BioNTech in people 16 and older.
As the first of the coronavirus vaccines to earn the federal government’s official nod, it’s a milestone that could prompt businesses and schools to issue vaccine mandates. And to hear public health officials and pollsters tell it, it could convince some unvaccinated people to get the shot as the Delta variant surges.
The approval itself was a much-anticipated decision. Real-world data on the shot’s safety and efficacy has been mounting since last December when the vaccine received emergency use authorization (EUA). Since then, it’s been administered hundreds of millions of times globally.
Just a few hours after the agency issued formal approval, the Pentagon said it will make vaccination mandatory, as did New York City schools. The approval was expected to lead to future vaccine mandates by employers, schools and institutions. United Airlines recently said that its employees will be required to show proof of vaccination within five weeks of regulatory approval.
The regulator’s imprimatur is also viewed as important given the sizable segment of Americans who remain vaccine-hesitant.
Francis Collins, director of the National Institutes of Health, told CNBC he hopes more reluctant or skeptical people will feel assured to “roll up their sleeves.” Acting FDA commissioner Janet Woodcock acknowledged as much, stating, “We recognize that for some, the FDA approval of a vaccine may now instill additional confidence.”
Shedding the “experimental” moniker could also defuse some of the rumors, misinformation and fear that had festered on the web.
“‘It’s not safe. It’s gonna cause a zombie apocalypse.’ It’s not. Can we at least agree that it’s safe? Take that off the table,” said Brian Castrucci, president and CEO of the nonpartisan de Beaumont Foundation. “Then we can debate everything else, such as ‘I believe in mask mandates for kids in school and verification for employers,’ which many are doing. Those are debatable points. This isn’t. It’s safe.”
Safety of vaccination and speed of development have been barriers to people choosing to take the shot since the foundation began its polling back when vaccination began, Castrucci recalled. To what extent might this ease those concerns and encourage more to get the shot?
According to a poll de Beaumont fielded last week in anticipation of yesterday’s news, 34% of unvaccinated Americans said the FDA’s full approval will address some or all of their concerns about the safety and effectiveness of the vaccine. That finding jibes with earlier studies indicating that lack of approval has been an issue among the hesitant.
Castrucci said he expects FDA’s imprimatur to “chip away” at the unvaccinated cohort. “Unfortunately, there is no magic spell. Words are important, but they’re not unequivocal,” he explained, adding that if half of the unvaccinated people in the U.S. convert to being vaccinated, it would represent “a win.”
Then again, half of the unvaccinated people in the de Beaumont poll said FDA approval won’t move the needle for them. Needless to say, vaccination has been hampered by a large partisan divide.
Republicans continue to exhibit high levels of vaccine hesitancy. The gap in vaccination rates between U.S. counties that voted for Joe Biden and those that voted for Donald Trump continue to grow.
“I doubt the FDA approval will have a big effect on vaccination rates in the U.S.,” wrote Robb Willer, a professor of sociology and psychology at Stanford University, in an email exchange. “More impactful would be for more Republican leaders to promote vaccination more prominently.”
As politicized as vaccination has become, the FDA’s approval process is a factual one involving rigorous testing and review by experts. The agency said it analyzed effectiveness data from vaccine and placebo cohorts numbering 20,000 apiece who were ages 16 and older and who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose.
Safety was assessed in vaccine and placebo groups of 22,000 apiece. Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. Those are immutable data, in contrast to fungible public opinion about the way the rollout has been carried out.
“This is a good solid data point for those who have been concerned about the safety of the vaccine,” said Castrucci. “If FDA approval helps unvaccinated Americans feel better about the safety of the vaccine, then that’s why we need media, political leaders and everyone to talk about this.
“It is a real scientific finding that we should be aggressively messaging as an indicator of safety,” added Castrucci, who said his foundation is working on a messaging toolkit to help people pick the right language when talking to the unvaccinated about the change.
“If you, for whatever reason, are unwilling to say, ‘This is a safe vaccine,’ then you should be calling into question every single pharmaceutical that’s available, because it went through the same [review] process,” he continued. “Do you pause before you take your antidepressants or your high blood pressure, diabetes or cholesterol medications? Because they’re all in that same process.”
As for the Pfizer/BioNTech shot finally being able to drop its emergency status, Castrucci said he was beginning to “feel sorry” for the EUA language. “The poor ‘E,’” he lamented. “Far too many people think it means experimental use, not emergency use. I feel bad for the ‘E.’ ‘E’ gets a bad rap in this.”