The world is desperately awaiting a COVID-19 vaccine, but not just any vaccine will do. We must ensure that any vaccine that emerges, particularly through an accelerated process, is proven safe and effective in a transparent and science-driven process. Without such assurance, much of the public may not buy into it.
The herd immunity that will end the pandemic requires all of us to get vaccinated. For that, we need public trust in the vaccine project. Polling indicates that a strong majority of Americans want a coronavirus vaccine to be fully tested, even if it could be available sooner without testing. We must not skip any tests in the vetting of COVID-19 vaccines, or we run the risk of people not voluntarily taking it, and it won’t give us the community-wide immunity needed to stop the spread.
Around the world, at least 35 vaccine candidates have entered human clinical trials, with eight large-scale “Phase Three” trials underway. The timeline to develop a vaccine may be compressed from several years down to just 12 or 18 months. However, moving with this remarkable speed does not — and must not — require cutting any corners. I am concerned President Trump may follow the example of Vladimir Putin, who claimed victory, stirred confusion, and rattled the vaccine race with a publicity-stunt approval of an unvetted vaccine dubbed “Sputnik V.”
The president has demonstrated his disrespect for established safeguards by publicly pressuring the Food and Drug Administration (FDA) to approve treatments despite inconclusive or debatable evidence — data he surely is not qualified to judge. It happened with hydroxychloroquine, and its authorization had to be shamefully retracted. And though the evidence for convalescent plasma therapy is more promising, Trump has cast a cloud over this potentially life-saving treatment with his political rhetoric about the “deep state” preventing the treatment from being approved.
We must be able to place our trust in the FDA’s tried and tested vaccine review process. This process remains the best in the world and will be able to clear a COVID-19 vaccine in record time while retaining a rigorous vetting standard.
This process will work if it is free from political meddling that could potentially compromise the safety and effectiveness of any resulting vaccine. One critical guardrail can protect the integrity of vaccine development, ensure the safety and efficacy of a COVID-19 vaccine, and boost public confidence with minimal additional effort. That is the Vaccine and Related Biological Products Advisory Committee, or “VRBPAC.” First coming to prominence in the Reagan years, VRBPAC has played a central role in the FDA’s process for assessing new vaccines. Review of a COVID-19 vaccine by this body of independent vaccine experts from academia and industry will add transparency, public accountability, and deliberative insight to the approval decision.
Although the benefits of VRBPAC are clear, it is currently merely optional. To firmly guarantee we receive the benefits of VRBPAC, I introduced the EVALUATE Act. This bill would require the FDA to receive from VRBPAC, in a meeting open to the public, advice on the safety and effectiveness of any COVID-19 vaccine before the FDA grants a license or emergency use authorization.
There is a strong consensus in the scientific community that the provisions of the EVALUATE Act are needed. Nearly 400 scientists signed a letter to the FDA urging VRBAPC review of COVID-19 vaccines. FDA officials have gone on record stating that VRBPAC “will be needed prior to vaccine authorization or licensure to ensure clear public understanding of the evidence supporting vaccine safety and efficacy.”
In the past seven months, we have learned that COVID-19 does not yield an inch to political tactics or media campaigns. It does not follow consumer sentiment polls or approval ratings. The impending election, the stock market, and the yearning for a return to normalcy must not distort the decision on whether to approve a vaccine. Only science and rigorous testing can bring an end to this pandemic — and then only if the public can trust in the result.
Congressman Raja Krishnamoorthi, a Democrat from Illinois, is Chairman of the House Oversight Subcommittee on Economic and Consumer Policy.