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 US National Vaccine Advisory Committee, a member of the American Academy of Pediatrics Committee on Infectious Diseases, the CDC’s Advisory Committee on Immunization Practices (ACIP) and the FDA’s Vaccines and Related Biological Products Advisory Committee (VRPAC). The opinions expressed in this commentary are those of the author. Read more opinion on CNN.
Operation Warp Speed, the mission to develop an effective Covid-19 vaccine, seeks to deliver 300,000 doses by January 2021. According to projections from the University of Washington, by then the US death toll from the novel coronavirus will likely have reached nearly 400,000.
What evidence of vaccine effectiveness – balanced by what assurance of safety – would prompt you to seek a dose of one of these novel vaccines to protect an elderly family member or for yourself?
Optimal use of these Covid-19 vaccines will depend on the confidence of the American people in the processes leading up to the vaccines’ release. The Food and Drug Administration’s (FDA) Biologics License Application (BLA) is the standard path to vaccine licensing. The rigor and transparency of this process ensures clinician and public confidence in vaccine safety and efficacy.
But now there is concern the FDA will sidestep the BLA and instead use an Emergency Use Authorization (EUA) to speed 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, should be fully transparent and include input from relevant federal advisory committees. The voting members of these committees are independent experts without ties to the federal government or to vaccine manufacturers. They should have access to the safety and efficacy data that informed the FDA’s decision to use the EUA process for the vaccine’s release. Only then can the process be seen as credible and free from political bias.
To foster trust in the expertise and integrity of those who review the vaccine and make recommendations to the public, there must be frequent communication from a group of HHS experts, such as leaders of Operation Warp Speed, the FDA and the Centers for Disease Control and Prevention, with only limited input from pharmaceutical representatives.
Safety reassurance
The public knowledge that the vaccine’s safety is being closely monitored even after EUA licensure would be especially important in building public trust. All vaccines are routinely checked and studied for safety after they become available to the public, and the novelty of this vaccine makes that process all the more important.
A federal Covid-19 vaccine safety task force should be established and, along with a group of independent experts, be charged with conducting rapid reviews of data from the federal safety monitoring systems and reporting to the public. To sustain public confidence, Covid-19 vaccine safety surveillance must continue for the foreseeable future to fully define the safety profile of these novel vaccines.
Engagement with the most-affected communities
Many demographic groups, such as Blacks and Native Americans, which have been disproportionately affected by the pandemic, have historically rooted deep distrust US public health. Some have already expressed concern that early access to an unlicensed vaccine distributed under an EUA because of their high-risk status would in fact once again be a plan to use them as unwitting experimental subjects.
It is, therefore, 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 expertise 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 by vaccines and reducing adverse reactions from vaccines, met this week to consider recommendations for the distribution of Covid-19 vaccines.
The committee seized the opportunity to make specific, detailed recommendations on the several actions Health and Human Services should take immediately to foster the public’s confidence in these vaccines and assure they are accepted by the American public.
Gaining the confidence of 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 realizing the full potential of these vaccines to control this pandemic.