Ethics Council: 'Nanocovax vaccine meets safety requirements'

Accordingly, the research team representativeNanocovax vaccinesubmitted the mid-term results data of phase 3 clinical trials as of September 2, updated on September 17. After listening to the reports and opinions of the members, the National Council of Ethics in Biomedical Research (abbreviated as the Ethics Council) concluded on three issues: Safety, immunogenicity and protective efficacy of the vaccine. This is the official conclusion from the second meeting of the Ethics Council to review the Nanocovax vaccine dossier on the afternoon of September 18.

Specifically, Nanocovax meets the short-term safety requirements, based on data reporting the mid-term results of phase three clinical trials to date. The assessment is based on the results of 7-day follow-up after the first injection of 11,430 volunteers, and the results of 7-day follow-up after the second injection of 5,785 volunteers.

The vaccine is also immunogenic. The assessment is based on data reporting the mid-term results of phase 3 clinical trials to date, including the results of Anti-S IgG antibody concentration tests on 924 samples on day 42 after the first injection; virus neutralization activity tests on 761 samples on day 42 after the first injection; and the geometric mean PRNT neutralization antibody titer on day 42 after the first injection of 107 Wuhan virus samples; 41 Delta virus samples; and 39 Alpha virus samples.

Medical staff prepare to inject the Nanocovax vaccine at Ben Luc District Medical Center, Long An, in February. Photo: Quynh Tran

Antibodies are part of the immune system, with IgG antibodies found in the blood and extracellular fluid, helping to protect the body from infection. Neutralizing antibodies are antibodies that attach to viruses, preventing the virus from infecting other cells. Antibody titer is the concentration of antibodies in the blood.

Quantitative antibody testing, neutralizing antibody evaluation, and neutralizing antibody evaluation on live virus by PRNT are important criteria for evaluating the immunogenicity of vaccines.

Regarding protective efficacy, "there is currently no data to directly evaluate the vaccine based on the number of Covid-19 cases in clinical studies". According to the Ethics Council, this is the most important result regarding vaccine quality. The research team needs to continue evaluating this aspect according to the approved protocol; estimating the protective efficacy of Nanocovax based on immunogenicity data, ensuring scientific assurance to transfer the dossier to the Advisory Council for drug and pharmaceutical ingredient registration for consideration.

From here, the Ethics Council unanimously agreed to allow the use of clinical trial research results up to the time of mid-term evaluation of phase 3 results, and send them to the Standing Advisory Council for Drug and Pharmaceutical Ingredients Registration (referred to as the Advisory Council) for consideration of emergency licensing. The Ethics Council also requested Nanogen Company and the research team to complete the report according to the meeting's conclusion, continue to implement the Nanocovax clinical trial research according to the outline to complete the research in March 2022 (phase 3c), and promptly update the research results to the professional Councils and management agencies.

On the evening of September 18, after the second meeting of the Ethics Council to review the Nanocovax vaccine dossier on the same afternoon, Professor Truong Viet Dung, Chairman of the Ethics Council, said that the results "basically met the requirements of the mid-term phase three".

After this meeting, in order, the results of the Nanocovax clinical trial will continue to be sent to the Advisory Council for the issuance of drug and pharmaceutical ingredient registration certificates for consideration of emergency licensing. The review meeting for licensing can be within three days after the Advisory Council receives the complete dossier and acceptance minutes from the Ethics Council. According to the representative of the Advisory Council, "the review meeting means that the council can propose to grant or not grant a license, request the enterprise to supplement the dossier", depending on the data received.

Nanocovax is a Covid-19 vaccine researched and developed by Nanogen Company, a two-dose regimen injected 28 days apart. Nanogen representative said the vaccine is produced based on recombinant technology, which means using the most suitable harmless antigen fragments (proteins) of nCoV to stimulate the creation of an appropriate immune response.

Currently, Nanogen is collaborating with the Military Medical Academy and the Pasteur Institute in Ho Chi Minh City to conduct phase three trials of the vaccine. The research team has completed two injections for 13,000 people in phase three trials, entering the process of monitoring and evaluating the vaccine and submitting a report to the Ministry of Health.