The European Medicines Agency's EU conditional marketing authorisations for COVID-19 vaccines
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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 [382]
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Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
Polack, F. P., Thomas, S. J., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Perez, J. L., Pérez Marc, G., Moreira, E. D., Zerbini, C., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2034577 · Cited by 14,592 · see citing works
Seroprevalence of anti–SARS-CoV-2 IgG antibodies in Kenyan blood donors
Uyoga, S., Adetifa, I. M. O., Karanja, H. K., Nyagwange, J., Tuju, J., Wanjiku, P., Aman, R., Mwangangi, M., Amoth, P., Kasera, K., et al. (2021) · Science · doi:10.1126/science.abe1916 · Cited by 328 · see citing works
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Advances in COVID-19 mRNA vaccine development
Fang, E., Liu, X., Li, M., Zhang, Z., Song, L., Zhu, B., Wu, X., Liu, J., Zhao, D., & Li, Y. (2022) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-022-00950-y · Cited by 601 · see citing works
Padín-González, E., Lancaster, P., Bottini, M., Gasco, P., Tran, L., Fadeel, B., Wilkins, T., & Monopoli, M. P. (2022) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2022.882363 · Cited by 166 · see citing works
Grieco, T., Maddalena, P., Sernicola, A., Muharremi, R., Basili, S., Alvaro, D., Cangemi, R., Rossi, A., & Pellacani, G. (2021) · Dermatologic Therapy · doi:10.1111/dth.15153 · Cited by 52 · see citing works
- Authors
- Cavaleri, M., Enzmann, H., Straus, S., & Cooke, E.
- Affiliations
- European Medicines Agency (NL)
- Federal Institute for Drugs and Medical Devices (DE)
- Corresponding author
- Cavaleri, Marco
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2021-01
- Volume
- 397
- Issue
- 10272
- Pages
- 355-357
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- PMC
- PMC7833511
- OpenAlex
- W3119846258
- Cited by
- 98
- References
- 2
- Citations by year
- 2026: 2 · 2025: 5 · 2024: 6 · 2023: 17 · 2022: 29 · 2021: 38 · 2020: 1
- FWCI
- 7.05
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- The Lancet (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Legal, Health, Environmental and COVID-19 Challenges
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Keywords
- COVID-19 vaccines, conditional marketing authorisation, European Medicines Agency, BNT162b2, mRNA vaccines, SARS-CoV-2, vaccine regulation, regulatory approval
- MeSH terms
- COVID-19, COVID-19 Vaccines, European Union, Humans, Marketing of Health Services, Drug Approval
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