An overly cautious FDA costs lives by not hastening vaccine authorization – Pacific Research Institute

An overly cautious FDA costs lives by not hastening vaccine authorization


The U.S. Food and Drug Administration’s vaccine advisory panel is set to meet on Thursday to consider an emergency use authorization, or EUA, for the COVID-19 vaccine jointly developed by Pfizer and German company BioNTech.

Despite newly reported deaths nationwide topping a thousand per day, the FDA doesn’t seem to have been in a hurry to review the companies’ vaccine, which proved 95% effective in clinical trials. The meeting will come nearly three weeks after the two companies submitted their request for an EUA. While the race for a COVID-19 vaccine has moved with unprecedented speed, the regulatory state hasn’t followed suit.

The Pfizer-BioNTech vaccine isn’t the only one waiting on federal regulators. Moderna applied for an emergency use authorization for its 94.5% effective vaccine on Monday. Its date with the FDA is not until Dec. 17.

The FDA has some definition of “emergency use.” During the two and a half weeks when we’re all waiting for federal regulators to give their verdict on Moderna’s vaccine, there will almost certainly be thousands more coronavirus deaths.

Incredibly, Moderna came up with the design for its vaccine over just two days in January. Historically, vaccine development and approval have taken a decade or more. The likes of Pfizer, BioNTech, and Moderna have shown that those historical timetables should be obsolete.

Or, perhaps they show that government regulation is the chief culprit behind long, expensive drug and vaccine development timetables.

There is obvious merit to careful testing and clinical trials, but as the COVID-19 pandemic is teaching us, people needlessly suffer and die because of regulatory inaction, too.

Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.

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