In a virtual meeting on October 22, a panel of academic experts in immunology, infectious diseases, and biostatistics debated the FDA’s guidelines for quickly and safely approving a coronavirus vaccine for widespread use.
The FDA Vaccines and Related Biological Products Advisory Committee meeting was intended to reassure Americans that vaccines will be held to high standards for safety and efficacy. The agency is requiring that any vaccine candidate be 50% more effective than placebo and that at least 5 patients in the placebo group develop severe COVID-19.
Some committee members questioned whether the FDA’s recommended 2 months of follow-up of clinical trial participants is enough to detect possible side effects, and whether the trials are designed to measure protection against severe illness requiring hospitalizations, as well as mild cases.
“When people hear the term ‘emergency use authorization,’ what they hear is ‘not necessarily approved or authorized product,’” said Paul Offit, MD, an infectious diseases physician at Children’s Hospital of Philadelphia, during the meeting. “They hear ‘a permitted product … a very low bar.’ … That’s not what we’ve been talking about the last few hours. … This is much, much closer to what is typically a [full approval] process. We need to make that clear.”
Lack of diversity among trial participants was also a concern, as communities of color have been hit hardest by COVID-19. “Since severe disease and death are occurring primarily among minorities with this virus, if we put a vaccine out there that does not address that issue, it’s going to perpetuate the perception that segment of our population does not matter much,” said committee member James E.K. Hildreth, PhD, MD, who is President of Meharry Medical College in Nashville, Tennessee.
In coordination with the U.S. government and funded by more than $10 billion in taxpayer money, pharmaceutical companies have developed six vaccine candidates that have yet to be proven safe and effective.