FDA Pulls Authorization for Original Pfizer and Moderna COVID Vaccines
The Food and Drug Administration pulled the emergency use authorizations for the original COVID vaccines produced by Moderna and Pfizer on Tuesday.
Both vaccines were authorized for emergency use more than two years ago after they were developed under Operation Warp Speed during the Trump administration.
In a news release, the FDA explained the older vaccines no longer offer full protection from new strains of the virus.
The agency said it had amended the emergency use authorizations of the initial Moderna and Pfizer-BioNTech vaccines in order 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 FDA said.
The agency stated both vaccines, which were approved in December 2020, are no longer authorized for use in the country.
“The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States” the FDA statement said.
Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said the agency concluded most Americans have antibodies to the virus by previous infection or via vaccination.
Marks also explained existing vaccines and booster guidance were outdated.
“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 said.
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.”
Marks concluded COVID continues to pose a “very real risk for many people” and asked Americans to stay up to date on their vaccines.
The FDA said people who are not vaccinated but wish to be should receive a single dose of an updated vaccine, rather than two doses that were previously recommended with the original vaccines.
Immediately following the emergency authorization of the original vaccines, many major cities across the country mandated their use for activities — such as shopping or dining.
New York City ended the vaccine mandate for city workers instated by former Mayor Bill de Blasio in February.
Mayor Eric Adams said at the time that city employees had “stepped up” when 96 percent of them complied with the mandate.
Many who did not were placed on unpaid leave or fired.
ABC News reported 1,780 New York City workers were fired for refusing the vaccines.
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