Editor's Note: Edgar Marcuse is emeritus professor of pediatrics at the University of Washington. The opinions expressed in this commentary are those of the author.
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.
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