US revokes authorisation of monovalent Moderna, Pfizer Covid vaccines

On Tuesday (April 18), the United States Food and Drug Administration (FDA) revoked the authorisation of ‘monovalent’ Moderna and Pfizer-BioNTech vaccines, which had been earlier in use in the direction of Covid-19.

In a press launch, it talked about, “The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.”

Meanwhile, FDA has authorised ‘bivalent’ vaccines to be used for all doses given to individuals 6 months of age and older. It needs to be talked about that ‘monovalent’ vaccines comprise only one stress of a virus whereas ‘bivalent’ vaccines comprise two strains of the virus.

The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines usually are not authorised for use inside the United States.

— U.S. FDA (@US_FDA) April 18, 2023

The current bivalent Covid-19 vaccines, permitted by the US Food and Drug Administration, comprise every distinctive and Omicron BA.4/BA.5 strains. Given that the virus that causes Covid-19 has mutated by the years, the efficacy of the monovalent vaccine (containing solely the distinctive stress) had decreased.

According to the Washington State Department of Health, preliminary data [pdf] has confirmed that bivalent Covid-19 boosters provided broader security than monovalent boosters.

While speaking regarding the matter, Peter Marks talked about, “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.”

Marks, who serves as a result of the Director of the FDA’s Center for Biologics Evaluation and Research, added, “Evidence is now available that most of the U.S. population 5 years of age and older have 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.”