Nanocovax is a Vietnamese COVID-19 vaccine candidate developed by Nanogen Pharmaceutical Biotechnology JSC. It is a subunit vaccine (SARS‑CoV‑2 recombinant spike protein with aluminum adjuvant).
Medical uses The vaccine requires two doses, administered 28 days apart. It is given by intramuscular injection.
Clinical trials
The Vietnamese health ministry has assessed the Nanocovax vaccine produced by Nanogen as the most promising, having been successfully produced on a laboratory scale and provoked immunogenicity during animal testing.
Preclinical and phase I Preclinical studies of Nanocovax were conducted on hamsters and non-human primates, including a challenge test, exposing hamsters to the SARS-CoV-2 virus. 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 Nanocovax showed the vaccine was safe and vaccinated volunteers had antibodies against the Alpha variant.
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, with 160 volunteers receiving each dose of the vaccine and 80 receiving the placebo. 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 had submitted a report to the Research Ethics Committee of the Ministry of Health and proposed a plan for the third phase of human trials. Dose strength of 25 mcg is selected for phase 3 to evaluate the vaccine efficacy.
Safety outcome Local adverse effects including pain were reported in 32.6% and 32.1% of the subjects after the first and the second doses, respectively. Systemic effects including fatigue and headache were found in about 16.9% and 13.3% of participants after each injection, respectively. Fever was rare but was reported in 3.8% of participants after both doses. SAEs were rare; however, severe back pain was reported in three patients, whereas one patient exhibited serious sepsis, and another patient experienced a severe sore throat. Milder adverse effects such as cough and sore throat were seen in less than 5% of subjects. Overall, adverse events were observed within two days and often resolved in seven days. No obvious relationship was observed between dose escalation and adverse events. The rate of adverse events was about 27% and 34% in the vaccinated and placebo groups, respectively. Laboratory aberrations such as hyperglycemia and leukocytosis were also reported. However, neither phase paused vaccinations because of adverse events. Some of the events, such as angina following a stent graft, sepsis, abscesses, personal injury, and anaphylaxis, were not related to the vaccination, the scientists found.
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