A Georgia Department of Public Health (DPH) official said Friday that her agency currently does not offer the Food and Drug Administration’s (FDA’s) fully approved COVID-19 vaccine, which the manufacturer, Pfizer, calls Comirnaty.
“Comirnaty has only recently become available, and DPH and its enrolled vaccine providers currently are using on-hand inventory of Pfizer COVID vaccine,” said DPH spokeswoman Nancy Nydam via email.
Nydam told The Georgia Star News that the federal government allots doses of the Johnson & Johnson, Moderna, and Pfizer vaccines for COVID-19.
“Providers place orders for vaccine based on their use and current inventory,” Nydam said.
The FDA first approved Comirnaty in August, according to that agency’s website.
“The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 in individuals 16 years of age and older,” according to the FDA’s website.
“Pfizer-BioNTech COVID-19 Vaccine is authorized for emergency use and is available under the EUA as a two-dose primary series for individuals 5 years of age and older, as a third primary series dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 16 years of age and older at least six months after completing a primary series of the vaccine.”
Whether Pfizer distributes Comirnaty is unknown, but the company told The Ohio Star this week that it is still shipping the EUA version of the vaccine.
“The Pfizer-BioNTech COVID-19 Vaccine (EUA labeled product) is currently being shipped; however, please be advised that the COMIRNATY and the Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably,” company officials said via email.
“They are made using the same processes, and there are no differences between them in safety or effectiveness.”
Pfizer did not respond when asked multiple times if Comirnaty is in use anywhere.
Though Pfizer says the vaccines are interchangeable, the FDA concedes that the products are “legally distinct.”
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Chris Butler is an investigative journalist at The Tennessee Star and The Georgia Star News. Follow Chris on Facebook. Email tips to [email protected].
Photo “Pfizer Vaccine” by Agência Brasília. CC BY 2.0.
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