Walvax COVID-19 vaccine

Part of a series on the
COVID-19 pandemic
COVID-19 (disease) SARS-CoV-2 (virus) Cases Deaths
Timeline 2019 2020 January responses February responses March responses April responses May responses June responses July responses August responses September responses October responses November responses December responses 2021 January responses February responses March responses April responses May responses June responses July responses August responses September responses October responses November responses December responses
Locations By country and territory Africa Antarctica Asia Europe North America Oceania South America By conveyance Cruise ships Naval ships
International response Evacuations Face masks International aid Investigations into origin Lockdowns Misinformation By governments China US Fake treatments Protests US Software Travel restrictions United Nations World Health Organization WTO IP waiver Undercounting of deaths National responses Africa European Union Germany Ghana India New Zealand Nigeria Philippines Russia Sweden UK government US federal government Vietnam
Medical response Disease testing Breathalyzer Development Drug development Drug repurposing Vaccines History Research VITT Deployment Authorizations Operation Warp Speed Misinformation and hesitancy US Vaccine card Vaccine passports CoronaVac Covaxin Convidecia Janssen Moderna Oxford–AstraZeneca Pfizer–BioNTech Sinopharm BIBP Sputnik V
Variants Variants of concern Alpha Beta Gamma Delta Omicron Other variants Epsilon Zeta Eta Theta Iota Kappa Lambda Mu Cluster 5 Lineage B.1.617
Economic impact and recession Arts and culture Aviation Cannabis Cinema films Disney Fashion Financial markets Food industry Canadian meat US meat Food security Journalism Music Performing arts Retail Shipping Sports Ireland Philippines Television US programs Tourism Video games By country Canada India Ireland Malaysia New Zealand Russia UK US
Impacts Animals Black people Crime Ireland Death rates by country Disability Domestic violence Emergency evacuations Education Female Ghana Ireland UK US Environment Hospitals Language LGBT community Long-term care Mental health Symptoms Migration Military Notable deaths South Africa Other health issues Politics Ireland Malaysia Russia Popular culture Protests Pregnancy Prisons Religion Catholic Church Hajj Science and technology Social media Society Ireland Malaysia New Zealand Russia UK US Strikes Suicides Telehealth Xenophobia and racism
COVID-19 portal
v t

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]

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]

References[]

Scholia has a profile for Walvax COVID-19 vaccine (Q106488871).