FDA Lays Out Guidelines For COVID-19 Vaccine Trials

WASHINGTON, DC — The head of the Food and Drug Administration says vaccine developers will be expected to study COVID-19 shots in racial minorities, the elderly, pregnant women and those with other health conditions.

FDA Commissioner Stephen Hahn outlined the guidelines for potential vaccines at a Senate hearing on reopening schools and workplaces.

Hahn says “while the FDA is committed to help expedite this work, we will not cut corners in our decision-making.”

The agency has come under criticism for granting emergency authorization to a malaria drug touted by President Donald Trump as a treatment for coronavirus. The agency revoked that designation earlier this month after studies found the drug was ineffective against the virus.

The U.S. is set to begin a 30,000-person trial of a government-created shot starting next month. Under the Trump administration’s program dubbed “Operation Warp Speed,” health officials aim to have 300 million doses on hand by January.

About 15 experimental COVID-19 vaccines are in various stages of testing worldwide. There is no guarantee that any will prove effective.