FDA’s Failure to Safeguard the Public Resulted in Irreparable Erosion of Trust

COVID Vaccines

FDA’s Failure to Safeguard the Public Resulted in Irreparable Erosion of Trust

Should the FDA have eased mRNA vaccine regulations during the pandemic and what are the safety consequences of regulatory delays?

Promise or Peril: COVID-19 mRNA Vaccine Issues Series

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Part 6

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In Part 6, we consider the ramifications of the “lagging” regulatory framework for COVID-19 vaccines. In June 2020, the U.S. Food and Drug Administration (FDA) set up special emergency guidance for the manufacturers making the COVID-19 vaccines; this special guidance expires on Nov. 7.

The FDA approval process is intended to safeguard human health when introducing new products. As established previously (in Part 1), mRNA is gene therapy yet the FDA has excluded vaccines from the normal testing requirements imposed on gene therapy products. The regulatory framework isn’t just “lagging,” the FDA guidance appears to have been derelict in its duty to properly test these new products.

FDA Negligence or Intentional Bypass?

Although ribonucleic acid (RNA) therapeutics have been in development for a decade, when messenger RNA (mRNA) technology was proposed for COVID-19 vaccines, a new set of regulatory rules were put in place to expedite production. The new rules allowed manufacturers to submit test results on similar products in lieu of submitting tests on the precise vaccine components.