We are profoundly concerned that avoidable missteps could undermine the rollout of the COVID-19 vaccination campaign.
The COVID-19 pandemic — and its enormous social and economic consequences — poses the greatest threat to human health and welfare of our lifetimes.
The fields of medicine and biomedical science to which we have devoted our careers are the most effective means to counter this scourge. Alongside preventative public health measures and treatments for the infected, developing a safe and effective vaccine to ward off SARS-Cov-2 infection is a critical national priority.
Urgency has motivated progress with unprecedented speed, and government investment and unprecedented collaboration among scientists within academia and at several biopharmaceutical companies have catalyzed the most rapid timeline for vaccine development in human history.
A return to our normal way of life will require public acceptance of the vaccine and delivery to a sufficient percentage of the population to achieve herd immunity.
Yet a recent Pew Research Center public opinion poll shows that almost half of the U.S. population definitely or probably would not get vaccinated at this time, indicating widespread vaccine skepticism. And 77% worry that a COVID-19 vaccine will be approved before safety and efficacy are rigorously established.
We are profoundly concerned that avoidable missteps could undermine the rollout of this essential vaccination campaign.
Vaccines are among the most important achievements of modern medicine, yet vaccine hesitancy — delay or refusal by the public to accept vaccines — has been increasing. This unfortunate phenomenon has many causes, ranging from complacency, to inconvenience, to misinformation and a lack of clear and balanced communication to the public about vaccine risk — spread powerfully via social media.
Moreover, the public reaction to COVID-19 in America has been highly influenced by political affiliation. Those who identify as Republicans tend to be far less likely to view COVID-19 as a major threat to public health and frequently invoke civil liberties to justify ignoring face coverings. A small but vocal minority even see the pandemic as a “hoax.”
President promotes misperceptions
These misperceptions are encouraged by a president whose messaging has often been at odds with experts at the National Institutes of Health and the Centers for Disease Control and Prevention, whether related to the extent of the pandemic, the utility of ineffective treatments such as hydroxychloroquine, or the likely timing of a vaccine.
The president appears motivated by political advantage in pressuring his administration’s “warp-speed” program to produce an effective vaccine by Election Day. The public skirmishes between the president and key science advisers raise legitimate concerns that political considerations will compel accelerated approval of a vaccine that would not ordinarily meet the standards for efficacy and safety expected by the Food and Drug Administration.
Lack of confidence among the public could impede the goal of vaccine-induced herd immunity.
While resisting both unsubstantiated vaccine hesitancy and politically driven premature vaccine approvals, it’s important to recognize that treatments and preventives always involve trade-offs between efficacy and risk.
Vaccines save countless lives and have all but eradicated smallpox and polio. Childhood illnesses like measles, mumps, rubella and chickenpox are but historical memories that younger parents have never witnessed.
Mistakes show why caution is needed
Even so, we cannot forget that some past vaccination campaigns exposed otherwise healthy individuals to disease: certain preparations of the Salk vaccine actually caused polio, swine flu vaccine was associated with a rare paralyzing neurologic syndrome, and early versions of vaccines for rotavirus produced an increased risk for a serious gastrointestinal condition in infants.
Other vaccines meant to prevent an infectious disease like dengue or severe acute respiratory syndrome have been associated with the potential to make the infection worse through a phenomenon dubbed antibody-dependent enhancement.
Because vaccines are administered to the healthy population, serious adverse events must be rare. Even the large Phase 3 trials underway might not readily identify uncommon adverse events that could surface only after broad public use and many months of experience.
Of course, the more lethal and widespread a disease, the more risk that may be deemed acceptable by regulators and the public; there are legitimate differences in opinion over where such lines should be set. It’s critical that risks and benefits be rigorously assessed and honestly communicated to the medical community and the population at large.
Though we await breathlessly for the arrival of a vaccine, much work remains before approval and dissemination. The results of numerous clinical trials must be rigorously evaluated by companies and the FDA, hopefully confirming strong signals of efficacy and safety for several vaccine candidates.
Accelerated approval of one vaccine could compromise efforts to compile comprehensive safety data and hinder recruitment to trials for alternative vaccines that might prove safer and more effective.
How can we increase the odds that vaccine approval will adhere to rigorous standards and be followed by efficient and ethical distribution of vaccine to those most in need?
First, key participants in the complex vaccine development ecosystem must exhibit seamless coordination, including public health experts, immunologists, infectious disease specialists and respected authorities within the FDA, CDC, NIH and the biopharmaceutical industry. These individuals will not, and need not, agree on every point of interpretation, but they must all pledge to be driven by the data and to resist political influence.
In addition to coordination, commitment to science and insulation from politics, the often-opaque process for evaluating data to justify regulatory approval must be maximally transparent, and vaccine trial data must be made widely available for analysis.
Together, coordination, commitment and transparency of the process will promote vaccine development that is trustworthy and of the highest integrity, as we should expect from the biomedical ecosystem in 2020.
If we succeed in meeting these standards, we can all be proud for history to hold us accountable.
Dr. George Q. Daley, Dr. Jeffrey S. Flier and Dr. Joseph B. Martin are the current and immediate past two deans of Harvard Medical School.
