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More than a third of Americans tell polls they would not take a vaccine to prevent COVID-19, the most devastating disease in 100 years. Vaccine hesitancy is even higher among Black people — hard-hit in this pandemic — with 40% reporting an unwillingness to take the vaccine.
Reluctance to take vaccines is not new. Why is the public unwilling to act in its own self-interest? Simply put — lack of trust.
If government doesn’t act to increase public confidence in the evaluation of COVID vaccines, many people won’t get vaccinated and tens of thousands will unnecessarily become infected and die. Absent high coverage of the population, vaccination will not achieve herd immunity, thus prolonging the pandemic in the U.S.
Over the past two weeks concern about eroding public trust has led to an extraordinary public pledge from vaccine developers to follow sound science, and editorials and press interviews from senior government officials seeking to reassure the public with promised transparency commitments. Even more unique have been virtual public contracts to resign — by the official running the federal vaccine program and the FDA’s senior official for vaccine approvals — if rigorous science isn’t followed.
We argue that two concrete policy steps could go a long way toward establishing public trust in COVID-19 vaccines: full and public disclosure of all data used to justify approval of a vaccine, and the creation of an independent and bipartisan committee to advise FDA.
BUILDING TRUST
The first critical step to building trust in a COVID-19 vaccine is regulatory review based on science.
FDA must firmly and unequivocally insist on strong scientific evidence that a COVID vaccine is safe and effective. Only then should the agency grant approval or authorize emergency use of the vaccine among the public.
Second, decisions by the Centers for Disease Control and Prevention about who gets priority for a COVID vaccine must be highly transparent.
Perceptions about science, fairness, and transparency — at different times and by different agencies — will strongly influence the likelihood of people taking vaccines. The public will not have confidence in a vaccine unless it believes it is safe and effective, and without public confidence the vaccine cannot be effectively or fairly deployed.
The last chapter of this steeplechase will be whether enough people get vaccinated.
An expert group just published a sobering article in The Lancet with an important cautionary note about the limitations of any single vaccine approval in arresting the pandemic. Even under FDA’s demanding criteria for approval, it is extremely unlikely that a single vaccine will be sufficient to secure community immunity.
Though multiple vaccines are needed, and quickly, rushing clinical development will only compound the challenges, making it harder to manage the refrigeration demands of some of the vaccine candidates and to enroll a fully representative sample of trial participants.
Not only do companies need to take the time necessary to run their trials properly, FDA must tell the whole truth about the resulting data — and limitations — in each vaccine approval.
The agency must not be politically pressured into an approval.
Ideally, FDA should follow the recommendation of global experts and insist that vaccine sponsors participate in multivaccine trials to speed enrollment and permit cross-vaccine comparisons.
This commitment entails working with — and not withdrawing from — the World Health Organization (WHO), along with participation in the WHO Solidarity Vaccines Trial and COVID-19 Vaccines Global Access (COVAX) Facility.
If the U.S. mismanages clinical development in its rush, and provides inadequate transparency into the trial results and FDA approval processes, we will not generate the information we need to sustain public confidence in any COVID vaccine, let alone all the vaccines we need to reach community immunity.
Without a complete disclosure of information on each vaccine, we won’t be able to effectively prioritize and provide authoritative guidance on use in high-risk populations, including the elderly, individuals with underlying health conditions and communities of color. We will also be limited in our ability to use data to address the concerns of those groups that polls suggest are vaccine-hesitant.
FDA can require vaccine companies to fully and publicly disclose the underlying safety and efficacy data used to justify approval, while still ensuring personal data are de-identified.
After approval, active collection and effective communication of postapproval safety, efficacy and utilization data by CDC and FDA will remain essential to maintaining public trust.
These steps need to include assurances of compensation for any vaccine-related injuries.
OUTSIDE ADVICE
In addition to full data disclosure, we argue the FDA and CDC should establish a joint independent advisory committee consisting of bipartisan former federal health officials to review and opine on the vaccine data, on both approval and allocation.
This step can help de-politicize the process and increase public confidence.
A panel of globally known, diverse, and bipartisan experts such as former government officials from FDA, CDC, NIH and the Office of the Surgeon General would be a great starting place.
This group should be chaired by a world-renowned leader with experience in industry, academia, and global health.
This group panel would serve as a second set of eyes on judgment calls and should be diverse in terms of gender, race, ethnicity and experience.
To be blunt, many of these experts will be called by reporters or appear on TV in response to government decisions, so why not build confidence by including them from the beginning?
The ultimate success marker in thwarting COVID won’t be speed, but safety and efficacy, and public trust.
We will prevail in this pandemic if we follow science, adhere to law without political interference, and secure the consent of people by making fair decisions about access to safe and effective vaccines. Beating COVID will take the vast bulk of us acting freely in our own personal interest to protect ourselves, our families, our friends.
We believe that the last chapter of this steeplechase will be whether enough people get vaccinated. Current and expected levels of vaccine hesitancy are far too high to end the pandemic.
If the United States links its scientific arsenal with the values of democracy: trust, transparency and accountability, we will demonstrate our global leadership across science and humanitarian dimensions.
David Beier is a managing director at Bay City Capital. Larry Gostin is university professor at Georgetown Law and founding O’Neill Chair in Global Health Law. Thomas Bollyky is director of the global health program and senior fellow for global health, economics and development at the Council on Foreign Relations (CFR).
Signed commentaries do not necessarily reflect the views of BioCentury.