The Ministry of Health (MoH) will license Nano Covax, the locally-produced COVID-19 vaccine, for domestic use in the event that the vaccine gathers full scientific data, according to a MoH official.
Nanogen, the developer of Nano Covax, has proposed the Ministry of Health approve its COVID-19 vaccine for emergency use in Vietnam,
Dr. Nguyen Ngo Quang, deputy director of the MoH’s Sci-tech and Training Department, made the statement following Nanogen Pharmaceutical Biotechnology JSC proposing that its COVID-19 vaccine Nano Covax receive approval for emergency use locally.
“The licensing of a vaccine for emergency use depends on many factors, and the MoH needs scientific data before it makes a decision,” Dr. Quang said.
He noted that Nanogen’s Nano Covax vaccine has yet to pass through all phases of tests in order to prove it has immunogenicity and provides effective protection and safety.
At present, Nanogen is in the process of carrying out the third phase of human clinical trials, with approximately 1,000 out of 13,000 registered volunteers being given their first shot of the vaccine so far.
According to details given by Dr. Quang, with 1,000 people inoculated, this represents only a small number compared to the millions of people who will go on to receive the vaccine in future.
The health official therefore stressed that in case Vietnam is not able to access vaccine imports ahead in August and September, then the MoH’s scientists will move to evaluate the results of Nanogen’s third phase and grant approval for Nano Covax to be used domestically in the event of an emergency.
“The Ministry of Health and I myself fully support the research and development of local vaccines to ensure supply sources for domestic use, and it is only approved in case of emergency,” said Dr. Quang, “But if we are able to access imported vaccines such as Pfizer, Moderna, Sputnik V and others approved by the World Health Organisation, priority will be given to import sources.”
The initial two testing phases of Nano Covax show that all injected volunteers have generated antibodies, whilst the vaccine itself is also effective against lineage B.1.1.7, known as the Alpha variant, which was first identified in the UK. In the third phase, developers will examine if the vaccine is effective against the mutated strain B.1.617.2, also known as the Delta variant, which originated from India.
Vietnam has reached numerous agreements with several global vaccine manufacturers, including AstraZeneca, Pfizer/BioNTech, and Sputnik V, to secure 120 million doses of COVID-19 vaccines for local use. However, manufacturers have yet to make any pledges or commitments regarding delivery time, thereby making it difficult for Vietnam to secure sufficient vaccines in a timely manner. So far this year over 2.5 million doses of the AstraZeneca vaccine have been delivered to the country.
To date, Vietnam has confirmed nearly 14,000 COVID-19 cases, including nearly 10,500 cases recorded during the latest outbreak which initially started in late April.