On Tuesday, the U.S Food and Drug Administration (FDA) announced that the monovalent Pfizer and Moderna mRNA COVID-19 vaccines are no longer authorized for use in the United States.
Monovalent vaccines contain one strain of a virus, while bivalent vaccines have two. For example, the COVID monovalent vaccine has mRNA from one strain, while the bivalent version has components from two strains.
The FDA’s decision follows a recent amendment to the Emergency Use Authorizations (EUAs) of the Moderna and Pfizer bivalent COVID vaccines.
The health agency has determined that bivalent vaccines, targeting both the original and omicron BA.4/BA.5 strains, will be used for all doses, effectively replacing the monovalent doses, according to a press release.
“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,” the press release reads.
“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.”
Some are questioning the timing of the FDA’s move.
Notorious undercover journalist and O’keefe Media Group (OMG) founder James O’Keefe asked his Twitter followers, “Can someone from the FDA please tell me what’s going on here? OKeefeTips@protonmail.com.”
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, stated, “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 that most of the U.S. population aged 5 and older now have antibodies to SARS-CoV-2 from either vaccination or infection, serving as a foundation for protection provided by the bivalent vaccines.
However, researchers from Pfizer and Moderna in Jun 2022 presented data on their bivalent vaccines to the FDA’s Vaccines and Related Biological Products Advisory Committee showing that bivalent boosters produce only slightly higher levels of neutralizing antibodies against specific virus strains compared to monovalent vaccines, according to an article published in The New England Journal of Medicine.
“The results were underwhelming,” the author writes. “Bivalent boosters resulted in levels of neutralizing antibodies against BA.1 that were only 1.5 to 1.75 times as high as those achieved with monovalent boosters.”
