October 7 2020 Alicia Ross, RN, BSN

Four former FDA commissioners and Dr. Peter Marks, the FDA official responsible for the oversight of vaccines, shared their thoughts on the FDA’s role in ensuring the safety and effectiveness of COVID-19 vaccines under extraordinary circumstances, in the ongoing pandemic.

The event, entitled “Safe and Effective COVID-19 Vaccination: The Path from Here” was hosted by the Duke-Margolis Center for Health Policy on September 10, 2020.

A partial list of speakers included:

  • Dr. Mark McClellan, Director, Duke-Margolis Center for Health Policy and former FDA Commissioner
  • Dr. Margaret (Peggy) Hamburg, National Academy of Medicine and former FDA Commissioner
  • Dr. Robert Califf, Google and Verily Health and former FDA Commissioner
  • Dr. Scott Gottlieb, American Enterprise Institute and former FDA Commissioner
  • Dr. Peter Marks, CBER, U.S. Food and Drug Administration

The discussion included details of the EUA (emergency use authorization) process and the conditions for which an EUA may be authorized for vaccine use across both high risk and broader population groups. It was reinforced that although an EUA is an expedited process, all vaccine candidates will undergo a vigorous review process, which includes Data Safety Monitoring Boards (DSMB), FDA advisory committee review, and public forum discussions. The speakers felt it was of paramount importance that the process was transparent to the public in order to ensure both acceptance and vaccine compliance. They recognized the need for the public to have confidence in both the review process and the personnel accountable for the vaccine’s review. It was noted that the FDA’s thoughtful response and management of any potential beneficial treatments for this public health crisis is probably one of the most important tasks the FDA has ever been called upon to do in its history.

The speakers discussed the mountain of challenges across all aspects of developing and distributing a vaccine under expedited timelines: testing, reviewing, approving, monitoring safety events, and the logistics of distribution for vaccines that may require specialized storage conditions. For current clinical trials, it was noted that there is a critical need for companies to ensure a diverse sample of trial subjects across both race and age distribution, especially the elderly. There was interesting conversation regarding the disproportionate severity and mortality of COVID infection amongst some races, with the African American population having a three times greater rate of severe outcomes from COVID. As the etiology behind these disproportionate finding is not currently clear, it makes it all more critical to ensure these populations are robustly represented within clinical trials. It was noted that there have been historical difficulties in reaching some of these under-represented populations and there are various active community outreach measures underway to ensure diverse representation within clinical trials.

Finally, the experts addressed how to best distribute a vaccine, for example a staged market entry, which would include initial administration to targeted groups such as health care workers and high risk populations.

I was impressed (and encouraged) to see how each speaker brought their own perspective and expertise to the challenges ahead, to ensure a more robust, safe and thoughtful reaction to this awful crisis.

Ensuring safe and effective COVID-19 vaccines under the extraordinary circumstances of an ongoing pandemic.

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