GPO announces NDV-HXP-S COVID-19 vaccine candidate (HXP-GPOVac) has entered phase 3 clinical evaluation.
Mr. Anutin Charnweerakul, Deputy Prime Minister of Thailand and the Minister of Public Health announces that GPO’s NDV-HXP-S COVID-19 vaccine candidate (HXP-GPOVac) has entered phase 3 clinical evaluation as a booster dose at Nakhon Phanom Hospital in Nakhon Phanom Province on 20th December 2022. The study is recruiting 4,000 volunteers 18 years of age and older, who were immunized with 2 doses of COVID-19 vaccine as a primary vaccination.
As the original 2019 coronavirus strain emerged, GPO switched its well-established egg-based vaccine production platform to manufacture a COVID-19 vaccine at industrial scale. This NDV-HXP-S vaccine project was initiated through a collaboration with PATH, Icahn School of Medicine at Mount Sinai (Icahn Mount Sinai) in New York, NY, the University of Texas at Austin (UT Austin) in the United States and three vaccine manufacturers in Brazil, Vietnam and Thailand.
The innovative vaccine candidate works by using inactivated Newcastle disease virus (NDV) expressing a stabilized spike protein of SARS-CoV-2 called HexaPro to induce the body to build protective defenses against COVID-19. The NDV-based vaccine technology was developed at Icahn Mount Sinai. HexaPro was developed at UT Austin with involvement from members of the same team that developed an earlier spike protein that is the basis of at least four COVID-19 vaccines currently being administered around the world. The vaccine seed virus is provided to GPO by Icahn Mount Sinai for production at the vaccine manufacturing plant in Saraburi Province. The HXP-GPOVac COVID-19 vaccine candidate is produced using egg-based technology, similar to that employed to produce influenza vaccines.
The vaccine is manufactured by GPO in Thailand and has a positive safety and immunogenicity profile from Phase 1 (2021) and 2 clinical studies (2021 and 2022). Phase 2 results helped determine a suitable formulation for the phase 3 clinical trial.
According to Dr. Withoon Danwiboon, GPO’s Managing Director, completion of the phase 3 study with positive results will enable dossier submission in 2023 to the Thai Food and Drug Administration for regulatory approval and, if approved, Thailand market distribution. GPO has the capacity to produce a potential 5-10 million doses a year-volume that can be expanded in the future.
Overall, the HXP-GPOVac vaccine has the potential to be an affordable, locally produced vaccine booster option that helps reduce imported vaccine costs and supports vaccine security for the next pandemic. This achievement highlights vaccine self-sufficiency and sustainability in Thailand.
https://www.gpo.or.th/view/751
