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  • Jonathan Poyer

Addressing the FDA Update on Moderna and Pfizer-BioNTech Vaccines

The FDA has updated guidance relative to the Moderna and Pfizer-BioNTech vaccines. We wanted to do our best to describe what this really means. In our opinion the update is simply meant to simplify things.

You can find the FDA update here:

FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines

From the article:

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.

The updated guidance is meant to simplify things. Only the bivalent vaccine will be used going forward – the original monovalent will be discontinued. The bivalent vaccine is simply a combination of the original monovalent vaccine with the omnicron construct added.

Put another way, the original vaccine is not being discontinued at all, rather, it is simply being co-administered with the follow-on omicron construct.

Back to the article:

Available data show that almost all of the U.S. population 5 years of age and older now have antibodies as a result of either vaccination or infection against SARS-CoV-2. The use of bivalent COVID-19 vaccines for all doses administered to individuals 6 months of age and older is supported by the data described below, as well as post-marketing data, including real-world data, with the monovalent and bivalent mRNA COVID-19 vaccines, which have been administered to millions of people, including young children. A second bivalent dose for individuals 65 years of age and older is supported by data showing the waning of immunity in this population over time and its restoration by an additional dose. Additionally, based on evidence from studies conducted previously, immunocompromised individuals may require additional doses.

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