Washington Post says Food and Drug Administration feels the need to ‘shore up public confidence’ in the COVID-19 vaccine project. Apparently they fear ‘the relentless politicization of the race to develop a vaccine’ is undermining confidence. FDA moves against fast track vaccines make the likelihood of having one before election day ‘unlikely’, it says.
The Facts Behind FDA Moves Against Fast Track Vaccines
Washington Post believes the new guidelines will be ‘far more rigorous than the emergency clearance of hydroxychloroquine or convalescent plasma’. They say the FDA moves against fast track vaccines are an effort to ‘shore up confidence. Confidence in an agency that made missteps during the pandemic’.
We understand the White House Office of Management and Budget is reviewing the proposal. However, some details are already in the hands of manufacturers. These apparently include a proviso to follow participants in late-stage clinical trials for a median of at least two months. And this period may only start after subjects receive their second COVID-19 vaccine shot.
A Thorny Issue and Tough Decision at Best of Times
Clearly, we need a COVID-19 vaccine as quickly as we can. However, equally clearly we cannot afford a vaccine that turns out to have serious side-effects. We already know half the American population already will not trust a vaccine sufficiently to take it. This is the dilemma causing FDA moves against fast track vaccines apparently to cool things down.
Peter Hotez, Dean of the National School of Tropical Medicine at Baylor College of Medicine came out in support of FDA. ‘Things are so revved up … there is quite a possibility that the American public won’t accept a vaccine. U.S. history is littered with good vaccines that get voted off the island because of bad public perceptions.’
Previous FDA Commissioner Robert Califf put the case for a softer approach succinctly, when he said ‘If there is definitive evidence of efficacy and no significant signal of toxicity or lack of safety, then withholding authorization would be an equal sin on the other side.’
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Preview Image: Fast Tracking COVID-19 Vaccine
