Vietnamese Vaccine and Biological Production Company No.1 (VABIOTECH) and AIC Group JSC have signed a contract with Japanese Shionogi & Co., Ltd to produce Covid-19 vaccines based on recombinant DNA protein technology.
| Inside a plant producing Sputnik V Covid-19 vaccine. Photo: Kinh Te Do Thi |
Under the deal, which was subject to a confidentiality agreement, local partners will produce recombinant protein-based vaccines, according to the Ministry of Health.
The vaccine rollout is expected to take place in June 2022.
According to Osaka-based pharmaceutical firm Shionogi, the recombinant protein vaccine contains the target antigen protein manufactured based on the genetic information of the virus.
The vaccine is manufactured based on established technology and several vaccines such as influenza prophylactic vaccine utilizing Baculovirus Expression Vector System (BEVS) have been approved and put to practical use based on its efficacy and safety.
In May, Shionogi said it may supply Covid-19 vaccines later this year.
Production roadmap
Last week, VABIOTECH produced the first batch of Russia’s Sputnik V Covid-19 vaccine. The first validation samples taken from the produced batch will be shipped to the Gamaleya Center for quality control.
VABIOTECH is able to produce five million doses per month from August and to raise the capacity to 100 million doses per year.
Dr. Do Tuan Dat, president of VABIOTECH said the move will help provide quality and affordable Covid-19 vaccines to Vietnam and other Southeast Asian countries.
At the National Assembly’s session last weekend, Health Minister Nguyen Thanh Long said Vietnam has signed three deals on producing vaccines with the US, Japan, and Russia.
Vingroup, Vietnam’s leading private conglomerate, plans to produce later this year messenger RNA (mRNA) vaccines capacity 100-200 million doses per year under the US tech transfer.
Regarding the development of domestic kinds, Nanogen Pharmaceutical Biotechnology JSC (Nanogen)’s homegrown Nanocovax vaccine, developed on the same protein-based recombinant DNA technology, almost finishes phase 3 clinical trials. The rollout is expected at the end of the year.
Vietnam was certified to have a fully-equipped national regulatory system for vaccine regulation in 2015.
The certificate means that Vietnam’s National Regulatory Authority (NRA) is compliant in all areas required to provide regulatory oversight of vaccines: overall system framework; marketing authorization and licensing; post-marketing surveillance, including for adverse events following immunization; lot release; laboratory access; regulatory inspections of manufacturing sites and distribution channels; and authorization and monitoring of clinical trials.
NRA indicates the World Health Organization (WHO)’s a rating scale for the safety and efficacy of vaccines.
