Is the FDA Too Cautious in Its Approach for Approving COVID-19 Vaccines?
“The vaccines are coming momentarily,” asserted President Donald Trump in his post-hospitalization video yesterday. The same day the White House reportedly first blocked and then scrambled to approve under pressure the Food and Drug Administration’s (FDA) proposed guideline that COVID-19 clinical trial vaccine recipients be followed for two months to evaluate vaccines’ safety before they can be approved for inoculating millions of Americans. The justification for first blocking the FDA guidance appears to be that that timeline would make it essentially impossible for a COVID-19 vaccine to be approved by the agency prior to Election Day.
Generally, it has taken 10–15 years for a new vaccine to be developed, tested, and approved. However, vaccines for COVID-19 are being developed and put into clinical trials in less than a year, an unprecedented speed. Given how the pandemic is evolving, is the FDA being too cautious?
An August 31 op-ed by two Harvard researchers in the Journal of the American Medical Association urged that the FDA stick to strict approval standards requiring that the COVID-19 vaccines show clinical benefit, not just pass some biomarker threshold such as producing a certain level of antibodies, before they are deployed. The authors warned:
Some have argued that extreme clinical need warrants backing away from the FDA’s historical standards requiring clinical benefit. This trend coincides with increasing political popularity of the libertarian “right to try” movement for medications, which advocates that patients should be able to access treatments not approved by the FDA. This approach was likely reflected in the presidential reasoning about unproven COVID-19 treatments: “Try it; what do you have to lose?”
The researchers conclude that “the nation’s health will be far better served by reliance on the usual rigorous approach to vaccine evaluation. Prem
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