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Revision as of 06:12, 19 December 2024
Vaccine against SARS-CoV-2Pharmaceutical compound
| Vaccine description | |
|---|---|
| Target | SARS-CoV-2 |
| Vaccine type | mRNA |
| Clinical data | |
| Trade names | Kostaive |
| Other names | ARCT-154 |
| ATC code | |
| Legal status | |
| Legal status |
|
| Identifiers | |
| CAS Number | |
| UNII | |
| KEGG | |
Zapomeran, sold under the brand name Kostaive is a self-amplifying mRNA-based COVID-19 vaccine. It contains a self-amplifying mRNA that encodes the SARS-CoV-2 spike protein. Self-amplifying means that the mRNA also carries instructions to make a protein called replicase.
Kostaive was approved for medical use in Japan in November 2023 and it is the first self-amplifying mRNA-based COVID-19 vaccine to be approved.
Medical uses
Zapomeran is used to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus.
Society and culture
Legal status
Kostaive was approved for medical use in Japan in November 2023.
In December 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Kostaive, a vaccine intended for the prevention of COVID-19 in adults. The applicant for this medicinal product is Arcturus Therapeutics Europe B.V.
Names
Zapomeran is the international nonproprietary name.
References
- ^ "Kostaive EPAR". European Medicines Agency (EMA). 12 December 2024. Retrieved 16 December 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- Ra J (13 September 2024). "Japan approves updated Covid-19 vaccine to tackle JN.1 variant". Pharmaceutical Technology. Retrieved 16 December 2024.
- https://www.meiji-seika-pharma.co.jp/pressrelease/2023/detail/pdf/231128_01.pdf
- Parkinson J (17 September 2024). "Japan Approves Updated Self-Amplifying mRNA COVID-19 Vaccine". ContagionLive. Retrieved 16 December 2024.
- "Japan's Ministry of Health, Labour and Welfare Approves CSL and Arcturus Therapeutics' ARCT-154, the first Self-Amplifying mRNA vaccine approved for COVID in adults" (Press release). CSL. 28 November 2023. Retrieved 16 December 2024 – via PR Newswire.
- "Japan's Ministry of Health, Labor and Welfare Approves CSL and Arcturus Therapeutics' Updated Self-amplifying mRNA COVID-19 Vaccine for Protection against JN.1 Strain, to be Distributed in Japan by Meiji Seika Pharma" (Press release). CSL. 13 September 2024. Retrieved 16 December 2024 – via PR Newswire.
- World Health Organization (2023). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 89". WHO Drug Information. 37 (1). hdl:10665/366661.
- World Health Organization (2024). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 91". WHO Drug Information. 38 (1). hdl:10665/378096.
Further reading
- Hồ NT, Hughes SG, Ta VT, Phan LT, Đỗ Q, Nguyễn TV, et al. (May 2024). "Safety, immunogenicity and efficacy of the self-amplifying mRNA ARCT-154 COVID-19 vaccine: pooled phase 1, 2, 3a and 3b randomized, controlled trials". Nature Communications. 15 (1): 4081. doi:10.1038/s41467-024-47905-1. PMC 11094049. PMID 38744844.
| Artificial induction of immunity / Immunization: Vaccines, Vaccination, Infection, Inoculation (J07) | |||||||||||
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