FDA-approved Comirnaty has the same formulation as the Pfizer COVID-19 vaccine which was previously cleared for emergency use in the United States
On August 23, the Pfizer-BioNTech vaccine became the first COVID-19 vaccine to receive full approval from the United States Food and Drug Administration (FDA). Prior to approval, the Pfizer vaccine had been authorized for emergency use (EUA) in the United States by the FDA since December 11, 2020.
When the approval was announced, the FDA and Pfizer-BioNTech said the vaccine would now be marketed under the name Comirnaty in the United States. A VERIFY viewer wants to know if the FDA-approved Comirnaty vaccine and EUA Pfizer COVID-19 vaccine contain the same ingredients.
Are Comirnaty and Pfizer COVID-19 vaccine the same?
Yes, Comirnaty and the Pfizer COVID-19 vaccine are the same.
WHAT WE FOUND
On December 21, 2020, the vaccine from Pfizer and BioNTech became the first COVID-19 vaccine to receive a conditional marketing authorization of the European Commission. The European Medicines Agency said the vaccine would be marketed under the name Comirnaty.
In a joint press release, Pfizer and BioNTech said they chose the name Comirnaty because it “represents a combination of the terms COVID-19, mRNA, community and immunity, to highlight the first clearance of a messenger RNA (mRNA) vaccine, as well as the global efforts that have made this achievement possible with unprecedented rigor and efficiency – and with safety at the forefront – during this global pandemic. â
A company called Brand Institute, which is an agency specializing in the development of brand names and identities, worked with Pfizer and BioNTech to come up with the name of the vaccine.
“All the staff of the Brand Institute and the Drug Safety Institute are honored to have partnered with two incredible companies, Pfizer and BioNTech, for the development of the brand of their COVID-19 vaccine, COMIRNATYÂ®”, said James L. Dettore, President and CEO of the Brand Institute, in December. âDesignating a product that will have such a profound impact on humanity is a lesson in humility and an opportunity for which we are truly grateful. “
According to the FDA, Comirnaty has the same formulation as the Pfizer COVID-19 vaccine which was previously authorized for emergency use (EUA) in the United States. It will continue to be given in a series of two doses, three weeks apart, for the prevention of COVID-19 disease in people 16 years of age and older.
âComirnaty contains messenger RNA (mRNA), a kind of genetic material. MRNA is used by the body to mimic one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will eventually respond defensively to the virus that causes COVID-19, âthe FDA said. When the Pfizer COVID-19 first received its EUA in December 2020, the FDA used a similar description to describe the properties of the vaccine.
A Pfizer spokesperson also told VERIFY via email that Comirnaty and the EUA Pfizer-BioNTech COVID-19 vaccine have the same formulation and can be used interchangeably to deliver the COVID-19 vaccination series, according to the ‘FDA labeling.
“In terms of ingredients and manufacture, the vaccine approved by the FDA for ages 16 and over is no different from the vaccine that has been administered to millions of people around the world to date as part of the vaccine. the EUA, âPfizer said.
For more information on Comirnaty, visit the FDA website.
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