The Food and Drug Administration released safety guidance for approving coronavirus vaccine candidates Tuesday, requiring proof that they are 50% more effective than the placebo in preventing infection.
The guidance applies to vaccine manufacturers seeking full regulatory approval, but the FDA said a vaccine could be introduced to the public under emergency use authorization, a less stringent safety designation.
Still, before granting emergency use authorization, the manufacturer will have to provide evidence from extensive clinical trials proving that the vaccine is safe. The guidelines say that decisions on granting such authorization will be made “on a case-by-case basis” depending on the “the characteristics of the product.”
“While the FDA is committed to help expedite this work, we will not cut corners in our decision-making,” FDA Commissioner Stephen Hahn said Tuesday. “This is particularly important, as we know that some people are skeptical of vaccine development efforts.”
The guidelines also stipulate that developers must conduct clinical trials with at least 30,000 people in order to gain approval. Hahn told the Senate health committee Tuesday that the FDA has urged vaccine developers to draw from a diverse group of people for clinical trials, such as the elderly and patients in minority groups who have experienced the most severe outbreaks.
Even after approving a vaccine candidate for public use, the FDA will also require manufacturers to monitor results in patients who received the vaccine to “further assess known or potential serious risks” to people’s safety.
Vaccine development has been moving at record speeds since the pandemic began as biotech companies race to be the first to receive FDA approval. President Trump has predicted that a vaccine will be available as early as late 2020, but infectious disease expert Dr. Anthony Fauci has remained “cautiously optimistic” that a vaccine will be ready by early 2021.
“The American people should know that we have not lost sight of our responsibility to maintain our regulatory independence and ensure that our decisions related to all medical products, including COVID-19 vaccines, are based on sound science and the available data,” Hahn said.
The FDA has fallen under intense scrutiny for granting emergency use authorization for the anti-malarial drug hydroxychloroquine, a drug that Trump touted as a possible COVID-19 treatment. More evidence emerged that the drug could cause more harm than good, and the FDA revoked the authorization.
