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. 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. The modRNA is formulated in lipid nanoparticles for administration via intramuscular injection in two doses, three weeks apart.

Comirnaty is undergoing evaluation in clinical trials in both the USA (NCT04368728) and Germany (NCT04380701). Comirnaty received fast track designation by the U.S. FDA on July 13, 2020. 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. Comirnaty was granted a EUA in the UK on December 2, 2020, and in Canada on December 9, 2020 for active immunization against SARS-CoV-2. Full FDA approval was granted on August 23, 2021.

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. Fact sheets for caregivers, recipients, and healthcare providers are now available. In November 2021, Health Canada and the EMA 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.

Comirnaty is fully approved by the FDA and Health Canada for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged five years and older. A third booster shot is also approved by Health Canada for individuals five years and older and by the FDA for individuals 16 or older, to be given more than 6 months after their second immunization. The interchangeability of Comirnaty with COVID-19 vaccines from other manufacturers to complete the primary vaccination course or the booster dose (third dose) has not been established. Comirnaty is also approved for use as a fourth booster shot in adults 50 years of age and older. In the US, under the emergency use authorization, Comirnaty is used for the prevention of COVID-19 in children 6 months of age and older.

Comirnaty is also available as an Omicron BA.4/BA.5 bivalent-adapted booster.

This vaccine should only be administered where appropriate medical treatment for immediate allergic reactions are immediately available in the case of an acute anaphylactic reaction after vaccine administration. Comirnaty administration should be postponed in any individual suffering from an acute febrile illness. Immunocompromised individuals maybe have a weaker immune response to Comirnaty.