Genexine said it has made a clinical strategic change of GX-19N, its Covid-19 vaccine candidate, to develop it as a booster shot that prevents breakthrough infections.
“We have submitted the change of plans to the ethical committee (EC) of Fakultas Kedokteran Universitas Indonesia Hospital and the Indonesian Ministry of Food and Drug Safety,” the company said. “We will also expand clinical trials to Argentina and other countries to conduct clinical trials on 14,000 patients.”
Genexine plans to divide participants into half and administer GX-19N to those that received Chinese-develop inactivated vaccine -- Sinovac or Sinopharm -- three months before the trial or a placebo to confirm the protective ability against infection.
A company official said the strategic change was due to difficulties in conducting clinical trials as unvaccinated patients gradually disappear.
“There might have been few problems if we had developed it quickly as a primary Covid-19 vaccine,” the company official told Korea Biomedical Review on Monday. “However, after conducting market research, we decided that developing a booster shot would be much more marketable.”
Genexine and PT Kalbe Farma decided on the strategic change from ethical and business considerations under the Covid-19 situations in the Southeast Asian country where about 20,000 new virus cases occur daily, most of them infected by the Delta variant, the company said.
As Indonesia is primarily using Sinovac vaccines to immunize its citizens, the Korean company judged that preventing breakthrough infection is more suitable, it said. In Indonesia, 57 million people, or about 21 percent of the population, have received the vaccine far, with most of its citizens either receiving Sinovac or Sinopharm.
As more than 63 countries have pre-purchased three billion doses of Sinovac and Sinopharm vaccines, including 160 million doses from Indonesia, the company expects that the demand for booster shots from these vaccines will continue, the company said, adding that it also plans to expand to other vaccine platforms such as recombinant protein, adenovirus, and mRNA.
“GX-19N, which is a DNA vaccine, is a safe vaccine with low risk of side effects even during additional inoculation and is the most suitable vaccine platform as a booster shot,” Genexine CEO Sung Young-chul said. “When using GX-19N as a booster shot, it has a wide range of antigen-specific T-cell responses and can form a higher level of antibodies to an already primed specific antigen.”