Adimmune Corporation (TPE: 4142) announced on the 13th its COVID-19 vaccine candidate has received the approval from the National Agency of Drug and Food Control of Indonesia (or Badan POM) for the Phase I/II dose finding study in Indonesia. With the Halal certification and a planned manufacturing site in Indonesia, Adimmune moves forward to access the Muslin market and ASEAN countries, and to further expand to the global market.
The Delta variant surges in multiple parts of the world. US, Europe, Taiwan, and Southeast Asia are again facing this resurgence of COVID-19. Indonesia is one of the most adversely affected countries by the Delta variant, but on the other hand provides an appropriate setting for Adimmune’s clinical trials to assess its vaccine’s protective efficacy. To be conducted by Universitas Gadjah Mada Medical School in Indonesia, the Phase I/II studies are expected to recruit 240 subjects to evaluate the re-designed dosages and validate the efficacy and safety of the vaccine. Data from the studies is estimated to be available next year. If the results conform with expectation, Adimmune will design and proceed with Phase III clinical trial which may incorporate components of the company’s next-generation vaccine currently under development, at various research centers in multiple countries.
Experts predict that COVID-19 will evolve into just another seasonal coronavirus (JASC). Booster shots may be required every year to maintain the antibody titers with the objective to reduce hospitalizations and deaths. From Adimmune’s studies and animal tests, positive results against COVID-19 variants were established after three shots of Adimmune’s vaccines. Adimmune is firmly on track to develop a safe, effective, and internationally approved vaccine against COVID-19.