Walvax COVID-19 vaccine: Difference between revisions
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'''ARCoV''', also known as the '''Walvax COVID-19 vaccine,''' is an [[RNA vaccine|mRNA]] [[COVID-19 vaccine]] candidate developed by Walvax Biotechnology, Suzhou Abogen Biosciences, and the [[PLA Academy of Military Science]].<ref name=":1">{{Cite web|title=SARS-CoV-2 mRNA vaccine|url=https://go.drugbank.com/drugs/DB15855|access-date=2021-04-10|website=go.drugbank.com}}</ref> It is approved for [[Phase III clinical research|Phase III]] trials in China,<ref name=":3" /> Mexico,<ref name=":2">{{Cite web|date=2021-05-11|title=Mexico to start late-stage clinical trial for China's mRNA COVID-19 vaccine|url=https://www.reuters.com/business/healthcare-pharmaceuticals/mexico-start-phase-iii-clinical-trials-chinas-walvax-covid-vaccine-2021-05-11/|access-date=2021-05-14|website=Reuters}}</ref> and Nepal.<ref name=":4">{{Cite web|date=2021-08-27|title=Nepal approves late-stage trials for Chinese mRNA vaccine candidate|url=https://www.reuters.com/world/asia-pacific/nepal-allows-late-stage-trials-chinese-mrna-vaccine-candidate-xinhua-2021-08-27/|url-status=live|access-date=2021-08-28|website=Reuters|language=en}}</ref> |
'''ARCoV''', also known as the '''Walvax COVID-19 vaccine,''' is an [[RNA vaccine|mRNA]] [[COVID-19 vaccine]] candidate developed by Walvax Biotechnology, Suzhou Abogen Biosciences, and the [[PLA Academy of Military Science]].<ref name=":1">{{Cite web|title=SARS-CoV-2 mRNA vaccine|url=https://go.drugbank.com/drugs/DB15855|access-date=2021-04-10|website=go.drugbank.com}}</ref> It is approved for [[Phase III clinical research|Phase III]] trials in China,<ref name=":3">{{Cite web|date=2021-07-22|title=Domestic clinical trials planned for China's mRNA Covid-19 vaccine|url=https://www.scmp.com/news/china/science/article/3142084/domestic-clinical-trials-planned-chinas-mrna-covid-19-vaccine|access-date=2021-07-23|website=South China Morning Post|language=en}}</ref> Mexico,<ref name=":2">{{Cite web|date=2021-05-11|title=Mexico to start late-stage clinical trial for China's mRNA COVID-19 vaccine|url=https://www.reuters.com/business/healthcare-pharmaceuticals/mexico-start-phase-iii-clinical-trials-chinas-walvax-covid-vaccine-2021-05-11/|access-date=2021-05-14|website=Reuters}}</ref> Indonesia,<ref name=":5">{{Cite web|date=2021-09-01|title=Indonesia, Mexico approve phase 3 trials of Chinese mRNA vaccine hopeful|url=https://www.scmp.com/news/china/science/article/3147168/coronavirus-indonesia-mexico-approve-late-stage-trials-chinese|access-date=2021-09-01|website=South China Morning Post|language=en}}</ref> and Nepal.<ref name=":4">{{Cite web|date=2021-08-27|title=Nepal approves late-stage trials for Chinese mRNA vaccine candidate|url=https://www.reuters.com/world/asia-pacific/nepal-allows-late-stage-trials-chinese-mrna-vaccine-candidate-xinhua-2021-08-27/|url-status=live|access-date=2021-08-28|website=Reuters|language=en}}</ref> |
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== Manufacturing == |
== Manufacturing == |
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=== Phase III trials === |
=== Phase III trials === |
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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.<ref>{{Cite journal|last=Walvax Biotechnology Co., Ltd.|date=2021-04-13|others=Abogen Biosciences Co., Ltd.|title=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|url=https://clinicaltrials.gov/ct2/show/NCT04847102}}</ref> |
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.<ref>{{Cite journal|last=Walvax Biotechnology Co., Ltd.|date=2021-04-13|others=Abogen Biosciences Co., Ltd.|title=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|url=https://clinicaltrials.gov/ct2/show/NCT04847102}}</ref> |
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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.<ref name=":3" /> |
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In May 2021, Phase III trials started [[Mexico]] with 6,000 people.<ref name=":2" /> Previously in 2020, Walvax had previously expressed an interest in making the vaccine in Mexico.<ref>{{Cite news| vauthors = Daniel FJ | date=2020-08-12|title=Mexico to trial China, U.S. COVID-19 vaccines, may produce some|language=en|work=Reuters|url=https://www.reuters.com/article/us-health-coronavirus-mexico-vaccine-idUSKCN2571TU|access-date=2021-04-10}}</ref> |
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In |
In August 2021, Phase III trials were approved in [[Mexico]] with 6,000 people.<ref name=":5" /> Previously in 2020, Walvax had previously expressed an interest in making the vaccine in Mexico.<ref>{{Cite news| vauthors = Daniel FJ | date=2020-08-12|title=Mexico to trial China, U.S. COVID-19 vaccines, may produce some|language=en|work=Reuters|url=https://www.reuters.com/article/us-health-coronavirus-mexico-vaccine-idUSKCN2571TU|access-date=2021-04-10}}</ref> |
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In August 2021, Phase III trials were approved in [[Indonesia]].<ref name=":5" /> |
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In July 2021, Phase III trials were awaiting approval by [[Malaysia|Malaysia's]] National Pharmaceutical Regulatory Agency (NPRA).<ref>{{Cite web|last1=Daim|first1=Nuradzimmah|last2=Yunus|first2=Arfa|date=2021-07-27|title=Dr Adham: Covid-19 vaccine development in recruitment phase {{!}} New Straits Times|url=https://www.nst.com.my/news/nation/2021/07/712133/dr-adham-covid-19-vaccine-development-recruitment-phase|access-date=2021-07-28|website=NST Online|language=en}}</ref> |
In July 2021, Phase III trials were awaiting approval by [[Malaysia|Malaysia's]] National Pharmaceutical Regulatory Agency (NPRA).<ref>{{Cite web|last1=Daim|first1=Nuradzimmah|last2=Yunus|first2=Arfa|date=2021-07-27|title=Dr Adham: Covid-19 vaccine development in recruitment phase {{!}} New Straits Times|url=https://www.nst.com.my/news/nation/2021/07/712133/dr-adham-covid-19-vaccine-development-recruitment-phase|access-date=2021-07-28|website=NST Online|language=en}}</ref> |
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In August 2021, Phase III trials were approved in [[Nepal]] with 3,000 people in [[Dharan]].<ref name=":4" /> |
In August 2021, Phase III trials were approved in [[Nepal]] with 3,000 people in [[Dharan]].<ref name=":4" /> |
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[[Colombia |
[[Colombia]], [[Pakistan]], and [[Turkey]] are other countries being considered for further trials.<ref>{{Cite web|date=2021-05-12|title=Late-stage trial of Chinese mRNA Covid-19 vaccine to begin in Mexico|url=https://www.scmp.com/news/china/science/article/3133200/coronavirus-late-stage-trial-chinese-mrna-vaccine-candidate|access-date=2021-05-17|website=South China Morning Post|language=en}}</ref> |
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== References == |
== References == |
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Revision as of 14:47, 1 September 2021
| 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 |
|---|
 |
|
.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 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
- ^ a b c "SARS-CoV-2 mRNA vaccine". go.drugbank.com. Retrieved 10 April 2021.
- ^ a b "Domestic clinical trials planned for China's mRNA Covid-19 vaccine". South China Morning Post. 22 July 2021. Retrieved 23 July 2021.
- ^ a b "Mexico to start late-stage clinical trial for China's mRNA COVID-19 vaccine". Reuters. 11 May 2021. Retrieved 14 May 2021.
- ^ a b c "Indonesia, Mexico approve phase 3 trials of Chinese mRNA vaccine hopeful". South China Morning Post. 1 September 2021. Retrieved 1 September 2021.
- ^ a b "Nepal approves late-stage trials for Chinese mRNA vaccine candidate". Reuters. 27 August 2021. Retrieved 28 August 2021.
{{cite web}}: CS1 maint: url-status (link) - ^ Yang, Brian. "How A Small Chinese Biotech Is Taking On mRNA Vaccine Giants". Scrip.
{{cite web}}: CS1 maint: url-status (link) - ^ Liu R (21 December 2020). "China starts work on plant for mRNA-based COVID-19 vaccine candidate - media". Reuters. Retrieved 10 April 2021.
- ^ "China's first mRNA vaccine ready for final stage trials". South China Morning Post. 13 April 2021. Retrieved 13 April 2021.
- ^ 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. PMC 7377714. 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}}: Cite journal requires|journal=(help) - ^ Daniel FJ (12 August 2020). "Mexico to trial China, U.S. COVID-19 vaccines, may produce some". Reuters. Retrieved 10 April 2021.
- ^ Daim, Nuradzimmah; Yunus, Arfa (27 July 2021). "Dr Adham: Covid-19 vaccine development in recruitment phase | New Straits Times". NST Online. Retrieved 28 July 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.
Scholia has a profile for Walvax COVID-19 vaccine (Q106488871).
