FDA’s New Vaccine Regulation Raises Standards for Drug Makers
Surrounding the Washington Memorial in D.C. are 20,000 flags, each one representing 10 people who have died from the virus.
The United States has reached another somber milestone in the coronavirus pandemic, surpassing 200,000 deaths.
As that death toll continues to rise, the Food and Drug Administration is raising the standards for a vaccine, saying it is imperative the vaccine is effective.
The FDA says it will now require drug makers to wait at least 60 days after giving trial patients a second dose before a vaccine can be approved.
With those standards in place, it will be virtually impossible to have a vaccine before Election Day, which Pfizer and its German partner, BioNTech, said was their goal last week.
Dr. Jay Varkey, associate professor of medicine at Emory University, says, “I think, mentally, the sooner the general public realizes that this is likely to push well into 2021 and that introduction of this vaccine is only beginning of the endgame to this pandemic, I think the better.”
A new model from the White House shows the U.S. death toll could rise to more than 375,000 by the end of the year.