Walvax COVID-19 vaccine
| Vaccine description | |
|---|---|
| Target | SARS-CoV-2 |
| Vaccine type | mRNA |
| Clinical data | |
| Routes of administration | Intramuscular |
| Identifiers | |
| DrugBank | |
| Part of a series on the |
| COVID-19 pandemic |
|---|
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.svg){kind=small} COVID-19 portal |
ARCoV, also known as the Walvax COVID-19 vaccine, is an mRNA COVID-19 vaccine candidate developed by Walvax Biotechnology, Suzhou Abogen Biosciences, and the PLA Academy of Military Science.[1] It is in Phase III trials in Mexico.[2]
Description[edit]
ARCoV is an mRNA vaccine which consists of lipid nanoparticle–encapsulated mRNA encoding the receptor binding domain of SARS-CoV-2. It was the first mRNA vaccine to be approved for clinical trials in China. Manufactured as a liquid, ARCoV is thermostable at room temperature for at least 1 week.[1] Reuters later reported that it can be stored at (2–8 °C) for six months.[2]
Scrips noted that Abogen created its own solid lipid nanoparticle to deliver the vaccine.[3]
Development[edit]
Phase I and II trials[edit]
Preclinical studies in mice and primates have shown ARCoV elicited a Th1-biased cellular response and robust antibodies against SARS-CoV-2.[1][4]
In June 2020, Walvax began a Phase I trial to evaluate safety, tolerance, and preliminary immunogenicity with 168 participants aged 18–59 in Hangzhou divided into low-dose, medium-dose, and high-dose groups.[5]
In January 2021, Walvax began a Phase II trial to evaluate immunogenicity and safety of different doses with 420 participants aged 18–59 in Yongfu and Xiangfen divided into low-dose, medium-dose, high-dose, and placebo groups.[6]
Phase III trials[edit]
The Phase III trials would enroll an estimated 28,000 participants. Elderly people over 60 years old are planned to comprise 25% of trial participants and randomly assigned into the study group and control group at a ratio of 1:1.[7] Tigermed, a Hangzhou-based clinical research organization, would be responsible for conducting the overseas trials. If successful, production of ARCoV could start in early 3rd quarter 2021.[8]
Reuters reported that Phase III trials in Mexico would involve 6,000 people and start by May 2021.[2] In 2020, Walvax had previously expressed an interest in making the vaccine in Mexico.[9]
Colombia, Indonesia, Pakistan, and Turkey are other countries being considered for further trials.[10]
Manufacturing[edit]
In December, Walvax started constructing a facility to produce 120 million doses of the vaccine each year.[11]
References[edit]
- ^ a b c "SARS-CoV-2 mRNA vaccine". go.drugbank.com. Retrieved 10 April 2021.
- ^ a b c "Mexico to start late-stage clinical trial for China's mRNA COVID-19 vaccine". Reuters. 11 May 2021. Retrieved 14 May 2021.
- ^ Yang, Brian. "How A Small Chinese Biotech Is Taking On mRNA Vaccine Giants". Scrip.
- ^ Zhang NN, Li XF, Deng YQ, Zhao H, Huang YJ, Yang G, et al. (September 2020). "A Thermostable mRNA Vaccine against COVID-19". Cell. 182 (5): 1271–1283.e16. doi:10.1016/j.cell.2020.07.024. PMID 32795413.
- ^ "A Phase I clinical trial to evaluate the safety, tolerance and preliminary immunogenicity of different doses of a SARS-CoV-2 mRNA vaccine in population aged 18–59 years and 60 years and above". Chinese Clinical Trial Register. 24 June 2020. ChiCTR2000034112. Archived from the original on 11 October 2020. Retrieved 6 July 2020.
- ^ "A Phase II clinical trial to evaluate the immunogenicity and safety of different doses of a novel coronavirus pneumonia (COVID-19) mRNA vaccine in population aged 18-59 years". chictr.org.cn. Chinese Clinical Trial Registry. Retrieved 20 March 2020.
- ^ Walvax Biotechnology Co., Ltd. (13 April 2021). "A Global, Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety, and Immunogenicity of a SARS-CoV-2 Messenger Ribonucleic Acid (mRNA) Vaccine Candidate in Population Aged 18 Years and Above". Abogen Biosciences Co., Ltd. Cite journal requires
|journal=(help) - ^ "China's first mRNA vaccine ready for final stage trials". South China Morning Post. 13 April 2021. Retrieved 13 April 2021.
- ^ Daniel FJ (12 August 2020). "Mexico to trial China, U.S. COVID-19 vaccines, may produce some". Reuters. Retrieved 10 April 2021.
- ^ "Late-stage trial of Chinese mRNA Covid-19 vaccine to begin in Mexico". South China Morning Post. 12 May 2021. Retrieved 17 May 2021.
- ^ Liu R (21 December 2020). "China starts work on plant for mRNA-based COVID-19 vaccine candidate - media". Reuters. Retrieved 10 April 2021.
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Scholia has a profile for Walvax COVID-19 vaccine (Q106488871). |
