HANOI, Aug 28 (Vietnam News/ANN): Vietnamese experts will consider licensing the emergency use of the locally-made Nano Covax vaccine in a special meeting to be held on Sunday (Aug 29).
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.
Meanwhile, Vietnam reported 12,103 new Covid-19 cases on Saturday (Aug 28), including 12,097 locally transmitted and six imported, according to the country's Ministry of Health.
The new infections brought the country's total tally to 422,469, with 10,405 deaths, the ministry said.
Most of the community cases were detected in southern localities, including 5,481 in the epicenter Ho Chi Minh City, 4,049 in nearby Binh Duong province, and 797 in Dong Nai province.
As many as 210,989 Covid-19 patients have so far recovered, up 12,375 from Friday, while over 19 million doses of Covid-19 vaccines have been administered nationwide, according to the ministry.
As of Saturday, Vietnam has registered a total of 418,330 locally transmitted Covid-19 cases since the start of the current wave in late April, the ministry said. - Vietnam News/ANN
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