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August 24, 2021August 23, 2021 – Pfizer and BioNTech have received full FDA approval for their vaccine to prevent COVID- 19 in individuals who are at least 16 years old. The vaccine, which was developed using mRNA technology, will be marketed under the brand name Comirnaty®.
- Comirnaty first reached the U.S. market after receiving emergency use authorization (EUA) on December 20, 2020. The FDA can issue an EUA to support access to non-FDA approved products during public health emergencies, so long as the known and potential benefits of the product’s use outweigh the known and potential risks.
- The current FDA-approved dosing is two intramuscular injections given three weeks apart.
- Comirnaty continues to hold an EUA to prevent COVID-19 in individuals 12-15 years of age, and for use as a booster shot for certain individuals who are immunocompromised have completed a two-dose course of vaccination with Comirnaty or the Moderna COVID-19 vaccine.