Walvax COVID-19 vaccine

Last updated

ARCoV
Vaccine description
Target SARS-CoV-2
Vaccine type mRNA
Clinical data
Routes of
administration
Intramuscular
Identifiers
DrugBank

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 approved for Phase III trials in China, [2] Mexico, [3] Indonesia, [4] and Nepal. [5]

Contents

Manufacturing

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. [3]

Scrips noted that Abogen created its own solid lipid nanoparticle to deliver the vaccine. [6]

In December, Walvax started constructing a facility to produce 120 million doses of the vaccine each year. [7] If successful, production of ARCoV could start in early 3rd quarter 2021. [8]

Clinical trials

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-2. [1] [9]

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. [10]

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. [11]

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. [12]

In July 2021, Phase III trials started in Yunnan and Guangxi in China with 2,000 people. Those provinces had previously experienced occasional small outbreaks from imported cases. [2]

In August 2021, Phase III trials were approved in Mexico with 6,000 people. [4] Previously in 2020, Walvax had previously expressed an interest in making the vaccine in Mexico. [13]

In August 2021, Phase III trials were approved in Indonesia. [4]

In July 2021, Phase III trials were awaiting approval by Malaysia's National Pharmaceutical Regulatory Agency (NPRA). [14]

In August 2021, Phase III trials were approved in Nepal with 3,000 people in Dharan. [5]

Colombia, Pakistan, and Turkey are other countries being considered for further trials. [15]

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References

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