The Institute of Vaccines and Medical Biologicals (IVAC) has successfully completed the phase 3 clinical trials for two influenza vaccines which are set to be licensed by 2019, IVAC director Lê Văn Bé has announced.— VNA/VNS Photo
KHÁNH HÒA — The Institute of Vaccines and Medical Biologicals (IVAC) has successfully completed the phase 3 clinical trials for two influenza vaccines which are set to be licensed by 2019, IVAC director Lê Văn Bé has announced.
The vaccine candidates include an inactivated trivalent seasonal influenza vaccine that targets three strains – A/H1N1, A/H3N2 and B – and an inactivated pre-pandemic influenza vaccine that targets A/H5N1, a type of avian influenza that has sporadically infected human populations in recent years.
“This is the result of a nine-year international partnership to improve Việt Nam’s vaccine production capacity and pandemic preparedness,” he said.
Overall results showed that both vaccines are acceptably safe and capable of prompting an immune response in healthy adults, Bé said.
Seasonal influenza is a viral disease that causes mild to severe respiratory illness and sometimes even death. It is responsible for up to 650,000 deaths and between 3-5 million cases of severe diseases world-wide each year.
The last major influenza pandemic to hit Việt Nam was the A/H1N1 pandemic in 2009. Lasting 12 months, it resulted in more than 284,000 fatalities worldwide, including 78,000 in Southeast Asia.
Việt Nam has lacked a sustainable supply of influenza vaccine and been forced to rely on foreign manufacturers. Local production of affordable seasonal influenza vaccine is the best way to ensure the country’s access to these lifesaving tools. It will help Việt Nam strengthen pandemic preparedness by facilitating a smooth transition from seasonal to pandemic production in case of need.
Since 2010, Programme for Appropriate Technology in Health (PATH) has collaborated with Vietnamese Ministry of Health in setting up a long-term plan for influenza vaccine production and use, and guidelines for influenza vaccine clinical trials and licensure. PATH has supported IVAC in the development of its egg-based seasonal and pre-pandemic influenza vaccines and Company for Vaccine and Biological Production No 1 in the development of new cell-based pre-pandemic inactivated A/H5N1 influenza vaccine.
The phase 2/3 clinic trials of IAVC’s seasonal influenza vaccine and A/H5N1 influenza vaccine were completed between 2017 and 2018, Bé said, nothing that this was the final evaluation required before the vaccine can be licensed for production.
Licensing applications for the above-mentioned vaccine candidate were underway and they were expected to be ready for circulation in 2019.
“The outbreaks of infectious diseases do not only threaten the health of ourselves and our families but also derail a country’s growth and development. Therefore, ensuring global health security is a priority for PATH,” said Nguyễn Tuyết Nga, PATH’s Việt Nam Deputy Country Director.
She applauded the diligence and commitment of her colleagues at the Ministry of Health, IVAC and related Vietnamese agencies in reducing the risk of future outbreaks.
The remarkable progress made towards sustainable influenza vaccine production confirmed Việt Nam’s position as a leader in vaccine production and development among low- and middle-income countries, Nga said.
Deputy Minister of Health Nguyễn Thanh Long revealed at a workshop on influenza vaccine production held in late August that Việt Nam has received the first order from the World Health Organisation.
The WHO praised the seasonal influenza vaccine of Việt Nam, he said, adding that the price of seasonal influenza vaccines 3 in 1 was VNĐ80,000-120,000 (US$3.5-5.1) per dose, only one third of the price of the imported one. — VNS