GPO :

INNOVATIVE CARE FOR LIFE

GPO :

INNOVATIVE CARE FOR LIFE

GPO starts a clinical trial phase 2 of a COVID-19 vaccine: After a successful clinical trial phase 1

April 25 2024
ขนาดตัวอักษร

Dr. Withoon Danwiboon, managing director, announces that GPO’s NDV-HXP-S COVID-19 vaccine candidate has entered phase 2 clinical study at the Faculty of Tropical Medicine, Mahidol University on 16th August 2021. The study is recruiting 250 volunteers aged 18–75 years old, who were not immunized with COVID-19 vaccine before and had not been infected with COVID-19. 

As a new 2019 coronavirus strain emerged, GPO switched its well-established eggbased vaccine production platform to manufacture a COVID-19 vaccine at industrial scale. This NDV-HXP-S vaccine project was initiated by the collaboration of PATH, Icahn School of Medicine at Mount Sinai (ISMMS), University of Texas at Austin (UTA) in the United States and three vaccine manufacturers in Brazil, Vietnam and Thaliand.  The innovative vaccine candidate works by using inactivated Newcastle disease virus (NDV) expressing HexaPro spike, the stabilized spike protein of SARS-CoV-2, to induce the body to build protective defenses against COVID-19. The NDV-based vaccine technology was developed at ISMMS. HexaPro was developed at UTA, by the same team that developed an earlier spike protein that is the basis of at least three COVID-19 vaccines currently being administered around the world. The vaccine seed virus is provided to GPO by ISMMS for production at the vaccine manufacturing plant in Saraburi Province. The NDV-HXP-S COVID-19 vaccine candidate is produced using egg-based technology, similar to that employed to produce influenza vaccines.

The vaccine was successfully manufactured in Thailand and entered into clinical trial phase 1 in March 2021. When a phase 2 clinical trial is accomplished, a suitable formulation will be selected for phase 3 clinical trial and distributed to the market after registration for Emergency Use Authorization (EUA) by Thai Food and Drug Administration. The potential of production is 20-30 million doses a year and can be expanded in the future.

According to Dr. Withoon, when the clinical trial phase 3 is completed and gets the EUA, 10-15 million Thai people will be vaccinated to protect against COVID-19 virus and the production is able to expand in the future. Hereby, it has the potential to reduce the cost of imported vaccines and to support vaccine sustainability. This achievement can bring back the confidence of people’s lives and it will help the recovery of the Thai economy.