Walvax COVID-19 vaccine

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ARCoV
Vaccine description
Target disease SARS-CoV-2
Type ?
Clinical data
Routes of
administration
Intramuscular
Identifiers
DrugBank DB15855

Lua error in package.lua at line 80: module 'strict' not found. 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

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

Phase I and II trials

Preclinical studies in mice and primates have shown ARCoV elicited a Th1-biased cellular response and robust antibodies against SARS-CoV-22.[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

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

In December, Walvax started constructing a facility to produce 120 million doses of the vaccine each year.[11]

References

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