Lauren Dempsey, MS in Biomedicine and Law, RN, FISM News
Yesterday, the U.S. Food and Drug Administration (FDA) announced changes to the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 mRNA vaccines in an effort to simplify the vaccination schedule.
The agency authorized bivalent vaccines to be used for all doses and administered to all eligible individuals aged 6 months and older. Under this new EUA, the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use.
The agency is making these changes in an effort to streamline vaccine guidance. Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said that the amendments come as the country transitions to an endemic phase and will increase vaccine uptake in vulnerable populations.
Marks explained, “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.” He added, “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.”
According to Marks, “COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination, including with a bivalent COVID-19 vaccine. The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death.”
The updated authorization makes a second omicron-targeted bivalent COVID-19 booster vaccine available for people over 65 or who are immunocompromised and expands availability to any adult who has not been previously vaccinated.
Children aged 6 months through 4 years of age who are unvaccinated are now eligible for a two-dose series of the Moderna bivalent vaccine or a three-dose series of the Pfizer-BioNTech bivalent vaccine. For children who are 5 years of age two doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine can be administered.
Children under 5 years old that have already been vaccinated with a monovalent vaccine may be eligible to receive a bivalent vaccine; however, it depends on vaccination history and how many doses of the COVID-19 vaccines they have already received.
In June, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will discuss the strain composition of the COVID-19 vaccines for fall of 2023 and will discuss which SARS-CoV-2 variants and lineages are most likely to circulate in the upcoming year, much like the agency does each year for the flu vaccine.
However, not all experts are in agreement with the agency’s decision to authorize and recommend additional doses or that there is clinical data that shows booster shots increase protection for those who are not at risk.
Dr. Paul A. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s vaccine advisory panel, wrote on Substack, “Trying to protect against all symptomatic illness would require frequent booster dosing, which is not a viable public health strategy.”
While Offit has been an outspoken vaccine advocate, he explained that “We’re the only country in this world that recommends a booster dose for everyone over 6 months of age,” and we are offering vaccines that were created for strains that are no longer circulating.
According to the Centers for Disease Control and Prevention (CDC), 81% of the total US population has been vaccinated and almost 17 % of the country has received an updated booster dose, and new cases and hospitalizations are all on a downward trend.