WASHINGTON — 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.
For most people, the new coronavirus causes mild or moderate symptoms. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia and death.
The United States has more than 2.6 million confirmed cases of COVID-19, according to statistics from Johns Hopkins University.
Just after 11:30 a.m. EDT Tuesday, the U.S. had 129,000 deaths from the virus. Worldwide, there are more than 10.4 million confirmed cases with more than 509,000 deaths.