FDA Pulls Authorization for Original Moderna and Pfizer COVID-19 Vaccines

On Tuesday, the U.S. Food and Drug Administration (FDA) repealed its authorization for the original versions of the Moderna and Pfizer COVID-19 vaccines, claiming that these vaccines were no longer effective against new strains of the virus.

The statement by the FDA relies heavily on the distinction between monovalent and bivalent vaccines: The former is designed to target a single strain of the disease, whereas the bivalent vaccines are intended to address multiple variants.

Instead of multiple doses of these original mRNA vaccines, the FDA now recommends taking newer iterations of the same products, which are designed to combat diversified strains.

“At this stage of the pandemic, data support simplifying the use of the authorized mRNA bivalent COVID-19 vaccines, and the agency believes that this approach will help encourage future vaccination,” said Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research.

The FDA also concluded that anitbodies to the once-novel coronavirus are widespread among the general population.

Marks continued: “Evidence is now available that most of the U.S. population 5 years of age and older has antibodies to SARS-CoV-2, the virus that causes COVID-19, either from vaccination or infection that can serve as a foundation for the protection provided by the bivalent vaccines.”

Despite these admissions, the FDA doubled down on its ecnouragement for people to keep up with the various vaccines and boosters still authorized.

The original Pfizer and Moderna vaccines were unique in their reliance on theretofore unused mRNA technology, which had been a subject of research for several decades but which had never been approved in a medical product for mass consumption.

That changed abruptly in December of 2020 when the FDA began to give emergency authorization for the two aforementioned mRNA COVID-19 vaccines. However, it was not until August 2021 that the FDA officially approved the first of these vaccines, which lawmakers claimed allowed them to impose vaccine mandates.

However, critics of these mandates have noted that the excess death rate continued to rise in 2022 despite — or, some might allege, because of — the new vaccines.

Despite these criticisms, the FDA has budged little in its position encouraging mass vaccine compliance. With the latest amendment to their recommendations, the agency effectively stays the course on the technology at large, even as it makes minor amendments to iterations of the vaccine it encourages.