Editor's Note:
Edgar Marcuse is Emeritus Professor of Pediatrics at the University of Washington.
He has served as a member and chair of the U.S. National Vaccine Advisory Committee, a member of the American Academy of Pediatrics Infectious Diseases Committee, the CDC Advisory Committee on Immunization Practices (ACIP), and the Advisory Committee on Vaccines and FDA Related Biological Products (VRPAC).
The opinions expressed in this comment are those of the author.
Read more opinion at cnne.com/opinion
(CNN) -
Operation Warp Speed, the mission to develop an effective covid-19 vaccine, seeks to administer 300,000 doses by January 2021. According to projections from the University of Washington, by then the number of deaths in the United States from the new coronavirus it will probably have reached almost 400,000.
What evidence of vaccine effectiveness, balanced for safety assurance, would lead you to seek a dose of one of these new vaccines to protect an elderly relative or yourself?
The optimal use of these COVID-19 vaccines will depend on the confidence of the American people in the processes leading to the release of the vaccines.
The Food and Drug Administration (FDA) Biologics License Application (BLA) is the standard pathway for vaccine licensing.
The rigor and transparency of this process guarantee the confidence of the public, and the physician, in the safety and efficacy of the vaccine.
But now there is concern that the FDA will bypass the BLA and instead use an Emergency Use Authorization (EUA) to expedite access to these vaccines.
If so, extraordinary actions will be needed to assure the public that these vaccines are very safe and effective.
Transparency
The EUA process for vaccine approval must be fully transparent and include input from the relevant federal advisory committees.
The voting members of these committees are independent experts with no ties to the federal government or vaccine manufacturers.
They must have access to the safety and efficacy data that informed the FDA's decision to use the US process for the vaccine release.
Only then can the process be considered credible and free from political bias.
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To build confidence in the expertise and integrity of those who review the vaccine and make recommendations to the public, there should be frequent communication from a group of Health and Human Services (HHS) experts, such as leaders from Operation Warp Speed, the FDA and the Centers for Disease Control and Prevention, with limited input from pharmaceutical representatives.
Security guarantee
Public knowledge that the safety of the vaccine is being closely monitored, even after authorization from the EUA, would be especially important in building public trust.
All vaccines are routinely monitored and studied for safety after they are made available to the public, and the novelty of this vaccine makes that process even more important.
A federal working group on COVID-19 vaccine safety should be established and, together with a group of independent experts, charged with conducting rapid reviews of data from federal safety monitoring systems and informing the public.
To maintain public confidence, surveillance of the safety of the COVID-19 vaccine should continue for the foreseeable future to fully define the safety profile of these new vaccines.
Commitment to the most affected communities
Many demographic groups, such as Blacks and Native Americans, who have been disproportionately affected by the pandemic, have historically ingrained a deep mistrust of America's public health.
Some have already expressed concern that early access to an unlicensed vaccine, distributed under an EUA due to its high-risk status, would, once again, be a plan to use them as unwitting experimental subjects.
Therefore, it is imperative that public health personnel engage with communities and groups disproportionately affected by COVID-19 to listen to their concerns, understand their values, and leverage their knowledge and experience to inform policy and practice decisions.
Expert Recommendations
The National Vaccine Advisory Committee (NVAC), which is charged with achieving optimal prevention of human infectious diseases through vaccines and reducing adverse reactions from vaccines, met this week to consider recommendations for the distribution of covid-19 vaccines.
The committee took the opportunity to make specific and detailed recommendations on the various actions that HHS should take immediately to build public confidence in these vaccines and ensure that they are accepted by the American public.
Gaining the trust of the American people in the processes and systems that lead to the development and distribution of COVID-19 vaccines is essential.
Only then will we have any hope of harnessing the full potential of these vaccines to control this pandemic.
Coronavirus vaccine