NMA Forms COVID-19 Task Force Take the Politics Out of Vaccine Development

Serious questions about the role of political influence on decisions made by the FDA have arisen. During the COVID-19 pandemic the United States Food and Drug Administration (FDA) approved emergency use authorization (EUA) for hydroxychloroquine and convalescent plasma. In both cases the established safety protocols involving completion of Phase 3 clinical trials for treatment of SARS-CoV-2 were bypassed. There were no apparent clinical trial safety equivalents to a surgical operation “time-out.” The earlier emergency use authorization (EUA) approval of hydroxychloroquine and the August 23rd EUA approval of convalescent plasma treatment preceding convening of the August 24, 2020 Republican National Convention are the reasons for those concerns. The former has been found to have adverse effects on COVID-19 patients and a panel of scientists from the National Institutes of Health has advised that there is “insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19.” These questions of political influence on scientific process because of Operation Warp Speed (OWS), have threatened the public trust in the FDA that will adversely affect participation in clinical trials, especially in the African-American community.

The protocols for the OWS clinical trials are overseen by the federal government, as opposed to traditional public-private partnerships, in which pharmaceutical companies decide on their own protocols. Rather than eliminating steps from traditional development timelines, the steps have been proceeding simultaneously, such as starting manufacturing of the vaccine at industrial scale well before the demonstration of vaccine efficacy and safety as happens normally.

To help address questions and concerns about efficacy, safety, and allocation of COVID-19 vaccines and therapeutics, a resolution was introduced by former National Medical Association (NMA) President Dr. Rodney Hood and passed by the House of Delegates in August 4, 2020 to establish a COVID-19 taskforce. The taskforce includes NMA physicians who belong to the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), Infectious Disease Society of America, Pediatric Infectious Disease Society, and the CDC Health Equity Workgroup. The NMA COVID-19 taskforce will be positioned to provide timely recommendations to physicians and the community about future emergency use authorizations by the FDA for COVID-19 vaccines and therapeutics currently undergoing evaluation in clinical trials. The taskforce findings will be especially critical if such an authorization occurs immediately before the November 3rd U.S. election.