Tozinameran

The Pfizer-BioNTech COVID-19 vaccine (also known as BNT162b2, Tozinameran, and Comirnaty), is one of four advanced mRNA-based vaccines developed through "Project Lightspeed," a joint program between Pfizer and BioNTech.L15002,L15007,L36025 Comirnaty is a nucleoside modified mRNA (modRNA) vaccine encoding an optimized full-length version of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein. It is designed to induce immunity against SARS-CoV-2, the virus responsible for causing COVID-19.^L15002 The modRNA is formulated in lipid nanoparticles for administration via intramuscular injection in two doses, three weeks apart.A225386,L15007

Comirnaty is undergoing evaluation in clinical trials in both the USA (NCT04368728) and Germany (NCT04380701).L15017, L15022 Comirnaty received fast track designation by the U.S. FDA on July 13, 2020.^L15027 On December 11, 2020, the FDA issued an Emergency Use Authorization (EUA) based on 95% efficacy in clinical trials and a similar safety profile to other viral vaccines over a span of approximately 2 months.^A225386 Comirnaty was granted a EUA in the UK on December 2, 2020,^L26676 and in Canada on December 9, 2020^L26671 for active immunization against SARS-CoV-2.^L26996 Full FDA approval was granted on August 23, 2021.^L36025

Currently, sufficient data are not available to determine the longevity of protection against COVID-19, nor direct evidence that the vaccine prevents the transmission of the SARS-CoV-2 virus from one individual to another.^L26956 Fact sheets for caregivers, recipients, and healthcare providers are now available.L26966,L26976 In November 2021, Health Canada ^L39115 and the EMA ^L39272 approved the vaccine to be administered as a booster dose approximately six months after the second dose. Comirnaty is also approved for use as a fourth booster shot in adults 50 years of age and older.^L41350