Should We Fast-Track a Vaccine for the Coronavirus?
The Food and Drug Administration is about to make the most momentous decision in its history: whether to authorize the early use of a vaccine to protect against the coronavirus without the normal safety and effectiveness protocols.
This is happening against the backdrop of the presidential election season, in which the pandemic has become a fraught political issue for the Trump administration. The wrong decision could seriously undermine efforts to prevent the spread of this deadly virus.
Significant risk may be acceptable for drugs intended to treat patients with serious, life-threatening diseases. The F.D.A. will approve a cancer drug with significant side effects, for instance, if it is demonstrated that the drug may prolong the life of the patient.
But for a vaccine, the agency has always demanded a higher level of assurance of safety, for a simple reason: The …continued .
[Source: New York Times]