Nanogen Pharmaceutical Biotechnology Joint Stock Company (Nanogen Company) has just submitted a petition to the Prime Minister about applying for a conditional emergency license for vaccines. NanoCovax. Currently, this vaccine is in phase 3a testing on 1,000 people, deployed by the Military Medical Academy and the Pasteur Institute in Ho Chi Minh City.
Regarding this recommendation, on the evening of June 22, Mr. Nguyen Ngo Quang, Deputy Director of the Department of Science, Technology and Training (Ministry of Health), affirmed that before a vaccine is released for public vaccination, In principle, the Ministry of Health must have data on safety, immunogenicity and especially protective efficacy.
Mr. Nguyen Ngo Quang said that “distributing a vaccine to the public needs evidence and must be very careful”.
According to Mr. Quang, the petition is the right of enterprises, and the permission or not is within the competence of specialized agencies, based on scientific data. The decision to make an emergency authorization for a vaccine depends on many factors. To decide whether to grant emergency authorization for a vaccine, the Department of Health’s Expert Panel needs scientific data.
“For the Nano Covax vaccine in phase 3 trials per 1,000 people, this is a small number, not yet community-based compared to the number of hundreds of millions of people using the vaccine later. To date, the research team The research has completed 1 dose of vaccine for 1,000 volunteers, but this number does not say much,” Quang said.
Quang said that the Ministry of Health previously calculated the plan, around August-September, if Vietnam does not have access to imported Covid-19 vaccine sources but the domestic epidemic is tense, it can be based on the following measures: The data proves the safety, immunogenicity and protective effect on the first 1,000 injections for the scientific council, the ethics committee of the Ministry of Health to consider licensing.
“However, this is an option to be considered in case of an emergency epidemic. In the event that Vietnam negotiates and masters the source of imported vaccines with vaccines with clear research results, such as: Pfizer, Moderna, Sputnik or other vaccines approved by the World Health Organization will prefer to use imported sources rather than vaccines with insufficient data.Moreover, the introduction of an injectable vaccine. It is necessary to have proof and to be very careful”- Mr. Quang emphasized.
Experimental injection of Nano Covax vaccine to volunteers
Mr. Quang affirmed that the view of the Ministry of Health is to fully support the research and development of vaccines in the country to take the initiative in Vietnam’s vaccine source. The prudent licensing approval does not have to be difficult for businesses. The Ministry of Health plays the role of health protection agency for the people, must carefully weigh the benefits and risks. “Nano Covax vaccine uses recombinant protein technology for production, which is the first technology developed in Vietnam, so more data is needed for evaluation,” he said.
According to Mr. Quang, the current data shows that the Nano Covax vaccine is safe, has immunogenic properties, but how effective it is is still under research and further testing. Therefore, in order to have enough scientific basis to evaluate, it is necessary to follow up after the first injection after 36 days, 45 days and 56 days. On that basis, it is enough to assess how immunogenicity and protective effect are. “So at least after 2 months and testing on this sample size can evaluate” – Mr. Quang informed.
Register for trial injection of Nano Covax vaccine
Previously, Mr. Ho Nhan, General Director of Nanogen Pharmaceutical Biotechnology Joint Stock Company (HCMC), had written to the Prime Minister to apply for an emergency license for the Nano Covax vaccine. This is a Covid-19 vaccine researched and manufactured by Nanogen. The vaccine has finished phase 1 and 2 clinical trials, has been well evaluated by the Ethics Committee of the Ministry of Health, and is in phase 3 of clinical trials on a scale of 13,000 people. Currently, 1,000 volunteers have completed the first dose of Nano Covax vaccine in phase 3.
Nanogen representative said that based on clinical trial results, the immunogenicity of Nano Covax vaccine reached 99.4%. If compared with other vaccines in the world, it is not inferior and somewhat higher. The expected selling price of this vaccine is VND 120,000/dose.
Up to now, the factory’s production capacity is estimated at 8-12 million doses/month. Based on current planning and capacity, the company expects to supply 50 million doses by December 2021 and 100 million doses by 2022.
From the above conditions, Nanogen Company proposes to the Government for the Nano Covax vaccine to soon be licensed with conditions, similar to the vaccines of Russia, China and India.