On Boosters, It's the White House vs FDA vs CDC vs Fauci vs 'The Science' | Opinion

In a virtually unprecedented move, Centers for Disease Control and Prevention Director Rochelle Walensky announced at 1:00 a.m. last Friday that she was very broadly approving booster shots for people under 65 whose occupations may put them at heightened risk from the coronavirus.

While the announcement aligned with a September 17 recommendation by experts at the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC), it directly contradicted a key CDC advisory panel, which had advised against approving boosters for people under 65. The panel in turn contradicted President Joe Biden. On August 18, he declared to all Americans, "Get a booster shot.... It will make you safer, and for longer. And it will help us end the pandemic faster."

This is yet another instance of the Biden White House and various public health entities offering confusing, shifting or outright contradictory guidance, weakening their own claims to authority and sowing distrust that undermines attempts to end this pandemic.

Many young, healthy Americans are delaying or declining vaccination because they are at low risk of death, according to the CDC. Furthermore, they have received no clear answers to legitimate questions about the safety of, and the conflicting opinions about, COVID vaccination and the inconsistently recommended boosters.

And there are, indeed, many such questions.

Why, for instance, did Biden's White House declare in August that it would begin a national campaign to administer booster shots, while the CDC's Advisory Committee on Immunization Practices was still studying the issue and had not made any recommendations?

Were patients still expected to follow the "get a booster shot" recommendation while their antibodies against COVID were still adequate? Why wasn't that specified in Biden's order?

Why did Anthony Fauci recommend boosters before hearing from experts at the FDA's VRBPAC?

Why the rash of sudden resignations of our nation's top government scientists working on the COVID response—including FDA senior vaccine science directors Marion Gruber and Phil Krause, and top CDC respiratory scientist Nancy Messonnier? Neither President Biden nor HHS Secretary Xavier Becerra have addressed the resignations.

Why has the FDA still not released its medical officer report on whether any Americans or others worldwide have died from receiving the various COVID vaccines, or any medical officer reports on alleged vaccine side effects?

Americans will continue to express these and other legitimate concerns until they get clear, competent answers from a transparent FDA. And after nearly two years of COVID-19's ravages, with the nation and economy yearning more than ever for stability, reassurance and clarity, the White House instead issues diktats: get a vaccine or be fired; get a booster shot before the science is in; don't ask questions.

Rochelle Walensky and Anthony Fauci
WASHINGTON, DC - JULY 20: Rochelle Walensky, Director of the U.S. Centers for Disease Control and Prevention (CDC), left, and Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, listen at a Senate Health, Education, Labor, and Pensions Committee hearing at the Dirksen Senate Office Building on July 20, 2021 in Washington, DC. The committee will hear testimony about the Biden administration's ongoing plans to deal with the COVID-19 pandemic and Delta variant. Stefani Reynolds-Pool/Getty Images

Americans know that complex answers take time, and that time used for objective analysis is the price paid for certainty. But for reasons that have not been adequately explained, the White House seems to think waiting for scientific evidence is inappropriate at best—or un-American, at worst.

The White House leapt from a policy of encouraging widespread voluntary vaccination, masks, distancing and testing to the big stick of vaccination mandates. One of Biden's recent orders mandated that most American workers get vaccinated, with threats of fines of up to $14,000 per violation for businesses that fail to support the policy.

Now that Biden is attempting to force 100 million Americans to be vaccinated, employers are flexing their newfound powers over their employees and firing those who don't comply. Biden's White House is now also considering issuing dishonorable discharge orders to military service members who refuse vaccinations as well. Will employers now mandate boosters for their workers, per Biden's demands, or will they follow the FDA vaccine committee experts who previously recommended against boosters? Will they follow Fauci's latest position on mask-wearing or stick to his previous ones? Out of frustration, will they simply refuse to wear a mask at all?

Historically, the president, the scientists and our health agencies have come together on public health questions and respect each other's domains.

Under the Trump administration, the FDA crowed loud and long about how important it was to "follow the science" and remain an independent public health organization. But can we really trust the Biden administration's still commissioner-less FDA to remain independent, given all the political pressure from the White House?

Although the FDA agreed with its experts at VRBPAC and recommended boosters, individual senior staff at the agency have the power to override their expert committees. We saw an example of that power, potentially due to White House pressure, from newly hired ex-Pfizer pharmaceutical executive Patrizia Cavazzoni, who was "leap-frog" promoted to be the new CDER scientific director at the FDA almost immediately following Biden's inauguration. Cavazzoni had written an op-ed pledging to "follow the science" no matter what—declaring to the world her unshakable dedication to evidence-based, data-driven approaches to public health.

However, following Biden's declaration of "war" against Alzheimer's disease, Cavazzoni ignored "the science" and spoke out against FDA experts who had unanimously voted against Biogen's aducanumab (Aduhelm) for Alzheimer's Disease. The data against Aducanumab's approval was nothing short of overwhelming.

The FDA has failed to "follow the science" with the Pfizer vaccine approval too.

The agency went from emergency authorization to full approval of its vaccine on August 23, but didn't—and still hasn't—released its final scientific medical officer report detailing the safety and efficacy of the Pfizer vaccine to the public. As a former FDA medical officer, I know of no other time when the FDA failed to release the safety and efficacy data on a final drug approval. Both the FDA and CDC have now seen the resignations of senior vaccine scientists. Surely this is no coincidence.

Medicine and health never used to consider politics a relevant data point, but the FDA's recent silence and back-bending shows this is no longer so. And the FDA is not alone.

Outside the FDA and other public-health alphabet agencies, we notice a conspicuous silence from otherwise vocal critics in the medical community. Health journalists who berated Donald Trump for allegedly jeopardizing public safety by "rushing" the emergency use authorization for COVID vaccines are now as silent as the grave about Biden getting ahead of the science and bullying scientists when it comes to boosters.

As a former Yale University professor of pharmacology, I recommend against holding your breath waiting on objective public health information, either from reporting or from the administration.

David Gortler, Pharm.D. FCCP, is a Fellow in the Ethics and Public Policy Center's HHS Accountability Project, where his work focuses on FDA oversight and drug safety. Prior to joining EPPC, Dr. Gortler worked at the U.S. Food and Drug Administration as a Senior Medical Analyst from 2007-2011, and as a Senior Advisor to the FDA commissioner from 2019-2021.

The views expressed in this article are the writer's own.