BNT162b2 mRNA COVID-19 Vaccine: First Approval
Open accessAbstract
BNT162b2 (Comirnaty®; BioNTech and Pfizer) is a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine for the prevention of the novel coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. BNT162b2 encodes the SARS-CoV-2 spike protein, the expression of which elicits immune responses against the antigen in recipients. In early December 2020, BNT162b2 received a temporary emergency use authorization (EUA) in the UK and, subsequently, a series of approvals or authorizations for emergency use in Bahrain, Canada, Mexico, Saudi Arabia and the USA. Soon after, BNT162b2 received conditional marketing authorizations in Switzerland (19 December 2020) and the EU (21 December 2020) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. BNT162b2 is administered intramuscularly in a two-dose regimen. This article summarizes the milestones in the development of BNT162b2 leading to these first approvals for the prevention of COVID-19.
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BioNTech/Pfizer proceeded with BNT162b2 in global phase II/III clinical trials on July 27, 2020, and it received EUA by the US government on December 11, 2020, and European Union conditional marketing authorization on December 21, 2020.
“BioNTech/Pfizer proceeded with BNT162b2 in global phase II/III clinical trials on July 27, 2020, which received EUA by the US government on December 11, 2020379,380 as well as the European Union conditional marketing authorization (CMA) on December 21, 2020.381,382”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [379]
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- Authors
- Lamb, Y. N.
- Affiliations
- Springer Nature (New Zealand) (NZ)
- Corresponding author
- Lamb, Yvette N.
- Venue
- Drugs
- Published
- 2021-03
- Volume
- 81
- Issue
- 4
- Pages
- 495-501
- ISSN
- 0012-6667 (ISSN-L)
- 1179-1950
- PMC
- PMC7938284
- OpenAlex
- W3133511640
- Cited by
- 424
- References
- 13
- Citations by year
- 2026: 44 · 2025: 63 · 2024: 77 · 2023: 98 · 2022: 97 · 2021: 44
- FWCI
- 9.24
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Drugs (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Legal, Health, Environmental and COVID-19 Challenges
- Keywords
- BNT162b2, COVID-19 vaccines, SARS-CoV-2, mRNA vaccines, lipid nanoparticle formulation, nucleoside-modified mRNA, spike protein, emergency use authorization, conditional marketing authorisation, vaccine development, vaccine approval
- MeSH terms
- Drug Development, COVID-19, SARS-CoV-2, COVID-19 Vaccines, mRNA Vaccines, BNT162 Vaccine, Bahrain, Canada, Clinical Trials as Topic, European Union, United Kingdom, Humans, Mexico, Saudi Arabia, Switzerland, United States, Vaccines, Synthetic, World Health Organization, Drug Approval, Spike Glycoprotein, Coronavirus
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