Will an Early Vaccine for COVID-19 Be Safe?
Columbia University Professor Emeritus, Dr. David Figurski
Donna O’Donnell Figurski
(Disclaimer: The World Health Organization <WHO> has officially named the new coronavirus as SARS-CoV-2 and the disease it causes as COVID-19. Because the majority of people, including much of the press, commonly refer to the virus as “COVID-19,” to avoid confusion I use COVID-19 as the name of the virus in these posts.)
There is intense pressure from this Administration for any good news that might bolster its re-election chances. The government’s own FDA (Food and Drug Administration) might shorten the three required clinical trials that are key to proving the safety and efficacy of any vaccine before it’s approved for use by the public.
There is good reason to be concerned that government officials from this Administration might approve short-cuts to well-established scientific requirements because they want to speed things up. Both the FDA and the CDC (Centers for Disease Control & Prevention), two government agencies I have always trusted, have already bowed to political pressure from this Administration. The FDA approved hydroxychloroquine use for COVID-19 and later rescinded its approval when the drug was found to be ineffective against COVID-19 and to cause some dangerous side-effects in some people. The CDC, after feeling pressure from the Administration, revamped its back-to-school guidelines.
Drs. Vincent Racaniello (virologist, Columbia U., host of the TWiV <This Week in Virology> podcasts), Brianne Barker (immunologist, Drew U.), and Rich Condit (retired virologist, Professor Emeritus, U. of Florida) discuss this issue in the TWiV podcast #631 of June 25, 2020. I urge you to listen to minutes 4:00-9:00. These three scientists talk about the importance of impartial and uncorrupted science in driving vaccine development and approval.
Also, an article about this issue can be found in the July 29, 2020, issue of HuffPost.
A legitimate way for the large Phase III clinical trial to end early is when the benefit is obvious. For example, if a vaccine candidate were given to 20,000 people and a placebo were given to another 20,000 people, the efficacy of the vaccine would be obvious (and statistically sound) if several hundred people in the placebo group became sick, while no person in the vaccine group became sick. Such an obvious result is exceedingly rare, and so, since it normally takes about eight months to do a Phase III clinical trial, if all goes well, we probably won’t have a confidence-inspiring vaccine until 2021.
Stay Safe and Healthy!
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(Photos compliments of contributor.)
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