Tozinameran
Tozinameran Uses, Dosage, Side Effects, Food Interaction and all others data.
The Pfizer-BioNTech COVID-19 vaccine (Tozinameran, INN), also known as BNT162b2, is one of four advanced mRNA-based vaccines developed through "Project Lightspeed," a joint program between Pfizer and BioNTech. Tozinameran 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.
Tozinameran is undergoing evaluation in clinical trials in both the USA (NCT04368728) and Germany (NCT04380701). Tozinameran 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. Tozinameran was granted an EUA in the UK on December 2, 2020, and in Canada on December 9, 2020 for active immunization against SARS-CoV-2.
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.
| Trade Name | Tozinameran |
| Generic | Pfizer-BioNTech COVID-19 Vaccine |
| Pfizer-BioNTech COVID-19 Vaccine Other Names | Tozinameran |
| Type | |
| Groups | Approved, Investigational |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Tozinameran is an mRNA vaccine for the prevention of COVID-19, the disease caused by the SARS-CoV-2 virus.
Tozinameran has not yet been fully approved by any country. In both the UK and Canada, Tozinameran is indicated under an interim authorization for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 16 years and older.
On December 11, 2020, the U.S. Food and Drug Administration granted emergency use authorization (EUA) for Tozinameran to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients aged 16 years and above. Safety and immune response information for adolescents 12-15 years of age will follow, and studies to further explore the administration of Tozinameran in pregnant women, children under 12 years of age, and those in special risk groups will be evaluated in the future.
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. Tozinameran administration should be postponed in any individual suffering from an acute febrile illness. Its use should be carefully considered in immunocompromised individuals and individuals with a bleeding disorder or on anticoagulant therapy. Appropriate medical treatment should be readily available in case of an anaphylactic reaction following vaccine administration.
Tozinameran is also used to associated treatment for these conditions: Coronavirus Disease 2019 (COVID‑19)
How Tozinameran works
Tozinameran contains nucleoside modified mRNA (modRNA) encapsulated in lipid nanoparticles that deliver the modRNA into host cells. The lipid nanoparticle formulation facilitates the delivery of the RNA into human cells. Once inside these cells, the modRNA is translated by host machinery to produce the SARS-CoV-2 spike (S) protein antigen, which is subsequently recognized by the host immune system. Tozinameran has been shown to elicit both neutralizing antibody and cellular immune responses to the S protein, which helps protect against subsequent SARS-CoV-2 infection.
Toxicity
Toxicity information regarding Tozinameran is not readily available. Patients experiencing an overdose are at an increased risk of severe adverse effects such as injection site reactions, headache, arthralgia, myalgia, fatigue, chills, and pyrexia. Symptomatic and supportive measures are recommended.
Innovators Monograph
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