Nanocovax

Nanocovax is a Vietnamese COVID-19 vaccine candidate developed by Nanogen Pharmaceutical Biotechnology JSC.

[7][8] 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.

[9] On 26 February 2021, the pharmaceutical company began second phase trials in two places, Hanoi and southern province of Long An.

[10] 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.

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.

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.

Surrogate virus neutralization test (sVNT) results were reported as mean inhibition rate (%).

Among 112 serum samples (at day 42) tested on Wuhan strain, a subset of 21 was randomly selected to evaluate neutralizing titer on Alpha variant (B.1.1.7).

[19][20] On September 18, 2021, the National Ethics Committee in Biomedical Research under the Ministry of Health (MoH) had reviewed and approved the clinical trial results of the phase III of Nanocovax.

According to President of the National Ethics Committee in Biomedical Research, Professor Truong Viet Dung, Nanocovax vaccine is safe and produces immune response.

At the data cutoff date of August 30, 2021, the solicited local adverse events in the 7 days post-injection 1 in both the Nanocovax 25 mcg and placebo groups were similar.

The most common adverse event was pain at the injection site, which occurrence in the vaccine and placebo groups was 30.3% and 26.4%, respectively.

Several systemic adverse events were also reported, showing that the most common systemic adverse events within 7 days of injection 1 in the vaccine and placebo groups were: fatigue 23, 7% and 24.6%, headache 16% and 17.2%, myalgia 15.6% and 17.6%, joint pain 10% and 10.7%, nausea/vomiting 2.9% and 2.8%, diarrhea 3.1% and 3.3%, fever 3% and 3.4%.

The most common solicited adverse events were: fatigue 15.4% and 13%, myalgia 9.2% and 8.8%, in the vaccine and placebo groups respectively.

Meanwhile, GMT of neutralizing antibody in placebo group was 10 (half of lower limit of detection).

We found the neutralizing antibody level induced by Nanocovax exceeded that of convalescent samples.

At the data cutoff date of August 30, 2021, the vaccine efficacy was yet to be concluded due to insufficiency of confirmed positive COVID-19 case.

[26] Comparing immunogenicity results of Nanocovax with those of COVID-19 convalescent patients evaluated by the Pasteur Institute in Ho Chi Minh City, as well as with the immunological results from other licensed vaccines, it was shown that the Nanocovax vaccine is effective in preventing COVID-19.

[24] The National Ethics Committee for Biomedical Research concluded that the Nanocovax vaccine estimated protective efficacy based on the immunogenicity data of the research ensured scientific validity, qualified to transfer the dossier to the Advisory Council for consideration.

[24] Accordingly, all dossiers and data presenting information about the search for the only made-in-Vietnam COVID-19 vaccine have been submitted to the MoH's Advisory Council for the Registration of Circulation of Drugs and Medicinal Ingredients for emergency use authorization.

The company is expecting to increase its capacity to 50-70 million doses a year to meet the domestic demand.

[28] If the government goes ahead with the emergency decision, it may be rolled out in May, a Nanogen official told Nikkei Asia in February 2021.

[29][30] On 22 June 2021, General Director of Nanogen said in an interview that the company had applied for an emergency authorization of Nanocovax in Vietnam the week before.