The Food and Drug Administration recently revised its emergency use authorization for Pfizer-BioNTech’s COVID-19 vaccine by approving a booster shot for individuals 65 and older, immunocompromised adults, and people with a high risk of exposure to the virus at work.
It’s an exciting development for the nearly 80% of vaccinated Americans who want a booster. But for many, the FDA’s announcement was confusing, too.
The debate over booster shots has been fraught with misleading information and contradictory federal guidance. This lack of clarity isn’t just a matter of semantics. It’s prolonging the pandemic and putting people’s lives at risk.
Take the in-fighting at the Centers for Disease Control and Prevention. Prior to the FDA’s approval of a Pfizer booster, a CDC advisory committee recommended that only people 65 and older and immunocompromised individuals between 50 and 64 get third shots.
Officials advised that high-risk patients between 18-49 be evaluated on a case-by-case basis, and the committee voted against giving boosters to people at high risk of occupational exposure.
One day later, CDC Director Rochelle Walensky overruled those advisors and included healthcare and other frontline workers in the CDC’s final recommendation.
The White House hasn’t made things much clearer for the general public. Two days after the FDA’s announcement, Biden promised to provide a third dose “across the board” to anyone who wanted one.
The president has consistently been at odds with both the CDC and FDA throughout the booster debate. In August, his administration announced it would start rolling out booster shots for all adults by mid-September. Public health officials from both agencies responded by insisting that boosters weren’t necessary for certain populations.
But the White House wasn’t swayed. According to reporting in Politico, administration officials “repeatedly accused CDC of withholding critical data needed to develop the booster shot plan.”
Shortly thereafter, two top FDA officials announced their departures from the agency in what was widely understood as a protest of the Biden administration’s position.
People are responding to these pitched battles between government agencies by tuning officials out. According to a new poll from Axios, over half of Americans have little to no trust in the president to provide them with accurate information about COVID-19. Nearly 45% of Americans don’t trust the CDC, and just 37% trust the FDA’s guidance on the pandemic.
Then there’s the absence of guidance on boosters for those who have received the vaccines from Moderna and Johnson & Johnson. It’s been over five weeks since Moderna submitted data to the FDA that demonstrated the safety and effectiveness of its booster shot. And just last week, Johnson & Johnson submitted its own application.
The FDA could make a decision on both shots “as early as this month,” according to reporting from the New York Times. That sometime in October constitutes “early” when Moderna’s data have been sitting with regulators for over a month is stunning. Unfortunately, it’s just one more example of the slow pace that has characterized the agency’s work throughout the pandemic.
That slowness is even more baffling given that there’s lots of evidence showing that boosters of Moderna and Johnson & Johnson are effective.
On September 21, J&J announced that its booster at two months provided 94% protection from COVID-19 and yielded a 12-fold increase in antibodies at six months, according to a Phase 3 study. Likewise, an analysis of real-world data released by Moderna in mid-September found that its vaccine, while still highly effective, would stand to gain from adding a booster to compensate for challenges associated with waning immunity over time.
Public health officials and regulators have been lecturing Americans for months about how they’re “following the science.” But that’s tough to believe when they sit on evidence for months.
It’s even tougher when public health officials prioritize equity concerns over safety, efficacy, and supply. Equitable access to vaccines is an important goal. But the FDA’s mandate is to screen for safety and efficacy—not to ensure that they’re going to those the public health establishment has deemed the “right” people.
A pandemic is no time for bureaucratic turf wars. Public health officials’ confusing and sometimes contradictory messaging poses a direct threat to our ability to recover from this pandemic—and respond to future ones.
Sally C. Pipes is president, CEO, and Thomas W. Smith Fellow in Health Care Policy at the Pacific Research Institute. Her latest book is False Premise, False Promise: The Disastrous Reality of Medicare for All, Encounter Books, January 2020. Follow her on Twitter @sallypipes.