Nanocovax

Nanocovax is a COVID-19 vaccine candidate developed by Nanogen Pharmaceutical Biotechnology JSC.
Description.
Nanocovax is a subunit vaccine (SARS‑CoV‑2 recombinant spike protein with aluminum adjuvant)
The vaccine requires two doses, the second one being administered 21 days after the first shot. 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. On 17 December 2020, Nanogen commenced human trials of Nanocovax vaccine.
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).
Phase II.
On 26 February 2021, the pharmaceutical company began second phase trials in two places, Hanoi and southern province of Long An. 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. Some volunteers experienced side effects around the injection site, yet did not require medical intervention.
Results of the trial issued in April 2021 show the homegrown COVID-19 vaccine is safe. 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.
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.
Deployment.
The vaccine can cost up to 120,000 VND or around per dose. 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.
Nanocovax vaccine may be ready to deliver to the general public in the second half of 2021, if efficacy is shown. If the government goes ahead with the emergency decision, it may be rolled out in May, a Nanogen official told Nikkei Asia. 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.