Thursday, September 23, 2021

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[Vietnam] License for emergency use of home-grown vaccine to be considered


HÀ NỘI — Experts will consider licensing the emergency use of the locally-made Nano Covax vaccine at a meeting scheduled for tomorrow.

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The National Committee for Ethics in Biomedicine Research under the Ministry of Health announced the news in a press release issued Saturday.

The ethics committee agreed to submit the results from Nano Covax's phase 3a clinical trials to the Advisory Council for the Registration of Circulation of Drugs and Medicinal Ingredients to consider issuing a licence for use with conditions for Nano Covax.

The Nano Covax vaccine meets the short-term safety requirements based on the data of the mid-term results of the phase 3a clinical trials, according to the release.

The committee requested Nanogen Biopharmaceuticals and the research team finalise the report, taking into account experts’ feedback, including adding more information to ensure the reliability of research results such as the range of test results and sample size of each test.

They are also required to update results of clinical trials for both the committee and the advisory council for evaluation.

If Nano Covax is licensed for use, it can only be used with conditions approved by the health ministry.

The safety of people being vaccinated needs to be followed as closely as it was during the phase 3b trial.

The ethics committee and advisory council will specify conditions of continuing or halting the circulation of vaccines when data on the safety and efficiency of the vaccine is available.

Nanogen is still conducting phase 3 trials with a total of 13,000 adult volunteers, but according to the latest guidelines from the health ministry, the vaccine could be given the emergency licence once the ethics committee approved the mid-term report.

Deputy minister of health Trần Văn Thuấn has said in the past that the issue of licence for use must be based on objective, transparent and scientific evidence reviewed and evaluated by the National Committee for Ethics in Biomedicine Research and the Advisory Council for the Registration of Circulation of Drugs and Medicinal Ingredients.

The health ministry will review licence for use for the drugs and vaccines that are approved by the independent agencies.

Vaccines are a special product that affects not only a person but the whole community, so it needs to be carefully considered, with consultation with reputable scientists and organisations such as the World Health Organization (WHO) and the US Center for Disease Control and Prevention (USCDC), according to Thuấn.

It was important to take careful steps to assess the safety (both short-term and long-term), stability and persistence of immunogenicity, especially the protective efficiency, the deputy minister said. — VNS

Published : August 30, 2021