Thai GPO launches 2nd phase of clinical trials of inactivated chimeric vaccine
Thailand’s Government Pharmaceutical Organization (GPO) launched the second phase of human trials of its COVIC-19 HXP-GPOVac vaccine candidate on Monday, after the completion of the first-phase trials which show satisfactory immune responses in human specimens.
GPO Director Dr. Withoon Danwiboon said yesterday that the new clinical trials, conducted by the Faculty of Tropical Medicine of Mahidol University and commissioned by the GPO, will involve 250 volunteers who are in good health, have not been inoculated with any COVID-19 vaccine and are not infected by COVID-19.
The GPO’s vaccine development project is supported by PATH, a global non-profit health organization, which has provided the Thai organization with a prototype vaccine, jointly developed by the Icahn School of Medicine at Mount Sinai and the University of Texas at Austin, in the United States.
The prototype vaccine has been used in the research, development and production of the HXP-GPOVac vaccine candidate, which is an inactivated chimeric vaccine, at the GPO’s vaccine production plant in in Saraburi province, said Dr. Withoon, adding that egg-based technology, which is used in the production of anti-flu vaccine, is employed in the production of the candidate vaccine.
After the completion of the third phase of human trials, he said he expects the candidate vaccine to be registered with the Thai Food and Drug Administration, under the Emergency Use Authorization (EUA) format, to be followed by mass production, tentatively due to start in the middle of next year.
The plant has the capacity to roll out 20-30 million doses of vaccine a year and can be expanded to produce more vaccine on continuous basis.
The vaccine yield should be enough to meet the requirement of 10-15 million Thais, said Dr. Withoon.
GPO’s vaccine project chief, Dr. Porntip Viratwong, explained that the prototype vaccine as a product of the development of modified Newcastle disease virus, to produce protein spikes similar to the spikes on the COVID-19 virus.
Similar prototype vaccine has also been sent to Vietnam and Brazil by PATH, said Dr. Porntip, adding that the GPO’s vaccine will be another option, which will enhance Thailand’s vaccine security and independence.
Common undesirable side effects from the vaccine include muscle pains and headaches, which will disappear after a certain period of time, but the vaccine is capable of stimulating immune response to contain the spread of the contagion at a satisfactory level.