(AmericanPoliticalDaily.com)- There has been a lot of talk about the U.S. Food and Drug Administration being pressured by President Donald Trump to push through approval of a coronavirus vaccine early so that it will help him at the polls on Election Day.
The leader of that organization said that has not happened to this point, and if it did, “all options are on the table” for him — including possibly resigning from his position. Dr. Stephen Hahn said:
“I can tell you, our decision at FDA will not be made on any other criteria than the science and data associated with these clinical trials.
“We will not make that decision on the basis of politics. That’s a promise.”
Many in the medical field are concerned the FDA will feel pressured to push through a vaccine approval just to try to curb the spread of the virus. To date, there are already 6 million confirmed coronavirus cases in the United States, with a possible serious spike coming over the fall and winter.
Still, others are concerned. Emergency physician Dr. Leana Wen spoke to CNN on Monday and said:
“We initially heard Dr. Hahn saying we need to wait until all the trials are in. Then we heard him say, well maybe we can do emergency use authorization right after Phase 3, and now we’re hearing that we don’t even need to wait until Phase 3 trials are complete.”
There are a few cases in the past where rushing a vaccine before it’s been proven to be both effective and safe resulted in disaster. A vaccine for the swine flu got hastily approved in 1976. The Centers for Disease Control and Prevention said that vaccine has been linked to people developing Guillain-Barre syndrome, a neurological disorder.
If anything negative were to occur with a coronavirus vaccine, the effects could be devastating. Not only would some people suffer negative health effects, but plenty of people would be hesitant to get a vaccine — even if it’s been proven safe and effective.
That’s why Dr. Howard Markel said it would be “colossally stupid” to approve a vaccine for use before all the late-stage clinical trials are completely finished. The director at the University of Michigan’s Center for the History of Medicine said:
“All it takes is one bad side effect to basically botch a vaccine program that we desperately need against this virus. It’s a prescription for disaster.”
Most health experts said a realistic expectation for a coronavirus vaccine is for one to be available early in 2021. Three vaccines are currently in Phase 3 clinical trials in the United States.
Late-scale trials have been underway by Pfizer/BioNTech and Moderna, and AstraZeneca began their Phase 3 trials on Monday. In Phase 3 trials, thousands of people are given the vaccine to determine if it’s effective. They are constantly monitored to make sure that the vaccine is safe for people to get as well.
AstraZeneca is including up to 30,000 adults in its study. Two doses are given of the vaccine roughly four weeks apart.