Genexine to develop GX-19N as booster vaccine
- To develop as a booster vaccine for Sinovac or Sinopharm vaccinated population. - DNA vaccine’s highest safety profile make the most suitable vaccine platform for booster vaccination.
[2021/08/30] Genexine (CEO Young-Chul Sung, Jungwon Woo, KQ 095700) announced on the 27th that it had changed clinical trial strategy from verifying the protective efficacy against healthy adults to adults with previously vaccinated in order to confirm the possibilities of GX-19N as booster vaccine from the global clinical phase 2/3.
Genexine applied to the Ethical Committee (EC) of FKUI (Fakultas Kedokteran Universitas Indonesia) and BPOM (Badan Pengawas Obat dan Makanan) for amending the clinical trial plan. At the same time, the company plans to expand clinical trials to Argentina and other countries and conduct clinical trials with a total of 14,000 patients.
In the GX-19N booter vaccine clinical trial, GX-19N will be administered to 50% of the participants and remaining 50% of those who had been vaccinated with Sinovac or Sinopham’s inactivated vaccines 3 months earlier will be administered with placebo. This efficacy evaluation design can confirm the protective ability against breakthrough infection. Among approved vaccines, a lot of the breakthrough infection cases has been reported from the population vaccinated with inactivated vaccines, making it suitable for research design to prevent actual breakthrough infection. The company plans to expand the study with other approved vaccines such as recombinant protein, adenovirus, mRNA vaccines.
Recently, the daily number of confirmed COVID-19 cases in Indonesia is around 20,000, and it has been found that most of them are due to delta variant infection. Particularly the number of breakthrough infections among those who have been vaccinated is increasing rapidly. Recently, the breakthrough infection rate in Indonesia is quite high, and it was found that most of them received the Sinovac vaccine.
In addition, while considering the Indonesian government's policy to ban non-vaccinated people from entering shopping malls and public places, some medical staff who participated in the Clinical Ethics Committee were concerned about the difficulties of clinical trials, including the placebo group, and requested a review of clinical changes. They pointed out firstly the ethical problem with existing clinical design because 50% of the participants must be remain unvaccinated at least one year due to sake of clinical trial. Secondly they worried that there can be lot of participants dropping out midway due to Indonesian government will increase vaccines supply.
Genexine and PT Kalbe Farma decided to change the clinical trial design, judging that the clinical trial as a booster vaccine is more appropriate strategy in terms of business feasibility as well as the Corona situation and ethical aspects in Indonesia. Considering the current vaccination rate, it is more advantageous due to annual revaccination market is increasing on the other hands the market for the unvaccinated getting smaller as time goes by.
In Indonesia, 21% of the population, 57 million people have been vaccinated so far, and most of them were vaccinated with Sinovac or Sinopham vaccines. Up to now, more than 3 billion doses of Sinovac and Sinopharm vaccines have been pre-purchased in 63 countries, including 160 million doses in Indonesia.
Genexine’s CEO Dr. Young-Chul Sung said, “The DNA vaccine GX-19N is a safe vaccine with highest safety profile, it will be the most suitable vaccine platform as booster vaccine. They can generate higher levels of antibodies to specific antigens that have already been primed, in addition to antigen specific T-cell responses.” In other words, the threshold for activation of memory B cells is lower than that of naïve B cells, so it is possible to form sufficiently high neutralizing antibodies even by secondary stimulation with DNA vaccine.
Meanwhile, according to Global Data, the global COVID-19 vaccine revaccination market is expected to reach 24 Billion dollars annually. |