Bass, Berry & Sims attorney Clint Hermes shared insight on the important role regulatory bodies, such as the U.S. Food and Drug Administration (FDA), will play in ensuring the safety and efficacy of a COVID-19 vaccine. Many are worried that in the rush to develop treatments and vaccines for the virus, the FDA will be pressured to approve a vaccine before it is ready. For example, earlier this year, the FDA issued (and subsequently revoked) an emergency use authorization (EUA) of hydroxychloroquine/chloroquine as a treatment for COVID-19 without any significant evidence in what Clint described as “not a shining moment.” Clint added that with the “COVID-19 vaccine guidance, the FDA is now pushing back and setting a much higher standard” for when an EUA would be granted, essentially saying that phase 3 trials will need to be done first.
“If there were safety issues with a vaccine, it would just be catastrophic, not just for the people that experience adverse effects, but for trust in the scientific establishment,” he added.
The full article, “FDA Guidance Eases Some COVID-19 Vaccine Concerns, But Others Remain,” was published by MedCity News on July 20 and is available online.