Biology:Nanocovax
| Vaccine description | |
|---|---|
| Target disease | SARS-CoV-2 |
| Type | Protein subunit |
| Clinical data | |
| Routes of administration | Intramuscular |
Nanocovax is a COVID-19 vaccine candidate developed by Nanogen Pharmaceutical Biotechnology JSC.[1][2][3][4]
Description
Nanocovax is a subunit vaccine (SARS‑CoV‑2 recombinant spike protein with aluminum adjuvant)[2]
The vaccine requires two doses, the second one being administered 21 days after the first shot.[2] It is given by intramuscular injection.
Clinical trials
The health ministry has assessed the Nanocovax vaccine produced by Nanogen is the most promising, having been successfully produced it on a laboratory scale and provoked immunogenicity during animal testing.
Preclinical and phase I
On 7 December, the National Institute of Hygiene and Epidemiology announced the Nanocovax test results on hamsters. The hamsters were vaccinated and then exposed to the novel coronavirus for 14 days. They were not infected and results from lung fluid tests also showed they were negative for the virus. Meanwhile, mice that were not vaccinated tested positive for the novel coronavirus and showed signs of fatigue.[5] On 17 December 2020, Nanogen commenced human trials of Nanocovax vaccine.[6][7]
The clinical trial Phase 1 (open-label, dose-escalation) recruited 60 healthy Vietnamese adult volunteers to evaluate the safety, tolerability, and initial assessment of immunogenicity of the vaccine intramuscularly in the participants. The first-stage trials of Nano Covax showed the vaccine was safe and vaccinated volunteers had antibodies against the UK variant (B.1.1.7).[8]
Phase II
On 26 February 2021, the pharmaceutical company began second phase trials in two places, Hanoi and southern province of Long An.[9] The clinical trial Phase 2 (randomization, double-blind, multicenter, placebo-controlled) enrolled 560 healthy volunteers to evaluate the safety, immunogenicity, and determined the optimal dose of the vaccine intramuscularly in participants. From 25 March to 6 April, volunteers receiving the first jabs in phase II between 26 February and 10 March were given the second shots of the Nanocovax vaccine.[10] Some volunteers experienced side effects around the injection site, yet did not require medical intervention.[11]
Results of the trial issued in April 2021 show the homegrown COVID-19 vaccine is safe.[12] According to the trial results, people injected with 25mcg dose got the highest index with more than 90% at 14 days after the second shot and 42 days since the first doses. The research team is expected to submit a report to the Research Ethics Committee of the Ministry of Health and propose a plan for the third phase of human trials, possibly on 5 May.[13]
Phase III
In April 2021, the representative of Nanogen JSC said that the third phase of the Nanocovax vaccine trial is expected to start on May and finish at the end of June, 3 months earlier than planned. The third phase of human trials is expected to involve 10,000-15,000 people in both Vietnam and Asian countries with severe outbreaks. Volunteers will be administered with 25mcg – the only dose for this stage. Each person will receive two jabs. They are set to get second shots 28 days after the first one.[14][13]
Deployment
The vaccine can cost up to 120,000 VND or around US$5.2 per dose.[15] Nanogen currently possesses the ability to produce 10 to 20 million doses a year. The company is expecting to increase its capacity to 50-70 million doses a year to meet the domestic demand.[15]
Nanocovax vaccine may be ready to deliver to the general public in the second half of 2021, if efficacy is shown.[16] If the government goes ahead with the emergency decision, it may be rolled out in May, a Nanogen official told Nikkei Asia.[12] On 26 March 2021, Deputy Minister of Science and Technology Phạm Công Tạc and Deputy Prime Minister Vũ Đức Đam received the second dose of the Nanocovax COVID-19 vaccine.[17][18]
References
- ↑ "VN starts injection of homegrown COVID-19 vaccine in first-stage human trial". Viet Nam News. 17 December 2020. https://vietnamnews.vn/society/830233/vn-starts-injection-of-homegrown-covid-19-vaccine-in-first-stage-human-trial.html.
- ↑ 2.0 2.1 2.2 "Draft landscape and tracker of COVID-19 candidate vaccines". WHO. 26 February 2021. https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines?.
- ↑ "How much does first Made-in Vietnam COVID-19 vaccine cost?". Voice of Vietnam. 11 December 2020. https://english.vov.vn/en/society/how-much-does-first-made-in-vietnam-covid-19-vaccine-cost-823392.vov.
- ↑ "Vietnam enters second phase of Covid-19 vaccine trials". VnExpress. 26 February 2021. https://e.vnexpress.net/news/news/vietnam-enters-second-phase-of-covid-19-vaccine-trials-4240748.html.
- ↑ Vaccine Covid-19 sắp tiêm thử ra đời như thế nào? VnExpress. 9 December 2020
- ↑ Vietnam begins human trials of Covid-19 vaccine VnExpress. 17 December 2020
- ↑ "Vietnam starts human trial of coronavirus vaccine". France 24. 2020-12-17. https://www.france24.com/en/live-news/20201217-vietnam-starts-human-trial-of-coronavirus-vaccine.
- ↑ Đã tiêm xong mũi 1 giai đoạn 2 vắc xin phòng COVID-19 Nano Covax cho 560 tình nguyện viên
- ↑ "Việt Nam thử nghiệm lâm sàng vaccine COVID-19 Nano Covax giai đoạn 2" (in vi). Lao Động. 2021-02-26. https://laodong.vn/y-te/viet-nam-thu-nghiem-lam-sang-vaccine-covid-19-nano-covax-giai-doan-2-883749.ldo.
- ↑ "Ông Vũ Đức Đam: 'Tôi sinh kháng thể tốt sau tiêm vaccine'". VnExpress. 2021-04-01. https://vnexpress.net/ong-vu-duc-dam-toi-sinh-khang-the-tot-sau-tiem-vaccine-4256801.html.
- ↑ "Volunteers get 2nd shot of Nano Covax vaccine in second trial phase". Vietnam News Agency. 2021-03-25. https://vnanet.vn/en/anh/vna-photos-1027/volunteers-get-2nd-shot-of-nano-covax-vaccine-in-second-trial-phase-5356176.html.
- ↑ 12.0 12.1 "Hanoi spurns China's vaccine diplomacy with homemade shot". Nikkei Asia. 2021-02-28. https://asia.nikkei.com/Spotlight/Coronavirus/Hanoi-spurns-China-s-vaccine-diplomacy-with-homemade-shot.
- ↑ 13.0 13.1 TIN VUI: Hoàn tất thử nghiệm vaccine COVID-19 ‘made in VietNam’ giai đoạn 2
- ↑ "Thử nghiệm giai đoạn ba Nanocovax sẽ tiến hành sớm 3 tháng" (in vi). VnExpress. 15 April 2021. https://vnexpress.net/thu-nghiem-giai-doan-ba-nanocovax-se-tien-hanh-som-3-thang-4263343.html.
- ↑ 15.0 15.1 "Vaccine Nanocovax giá 120.000 đồng một liều". VnExpress. 2020-12-10. https://vnexpress.net/vaccine-nanocovax-gia-120-000-dong-mot-lieu-4204359.html.
- ↑ "Vaccine Diplomacy Is Biden's First Test in Southeast Asia". Center for Strategic and International Studies. 28 January 2021. https://www.csis.org/analysis/vaccine-diplomacy-bidens-first-test-southeast-asia.
- ↑ Hà Minh (2021-03-26). "Phó Thủ tướng Vũ Đức Đam tiêm thử nghiệm vắc xin 'made in Vietnam'". Tiền Phong. https://tienphong.vn/pho-thu-tuong-vu-duc-dam-tiem-thu-nghiem-vac-xin-made-in-vietnam-post1323244.tpo.
- ↑ Viết Tuân; Chi Lê (2021-03-26). "Phó Thủ tướng Vũ Đức Đam tiêm thử vaccine Nano Covax". VnExpress. https://vnexpress.net/pho-thu-tuong-vu-duc-dam-tiem-thu-vaccine-nano-covax-4254285.html.
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