Merah Putih vaccine phase 3 trial conducted alongside booster trial

Ketua Peneliti Vaksin Merah Putih di Universitas Airlangga Surabaya Prof Fedik Abdul Rantam saat menyampaikan keterangan kepada wartawan di PT Biotis, Kabupaten Bogor, Jawa Barat, Jumat (8/4/2022). (ANTARA/Andi Firdaus)

Jakarta (ANTARA) - The third phase of Merah Putih Vaccine's clinical trial is conducted in parallel with the booster trial, Merah Putih Vaccine Researcher Head at Airlangga University, Surabaya, East Java, Abdul Rantam stated.

"We plan this to be held in parallel to shorten the time period. Hence, the third phase and booster trial are conducted simultaneously due to the emergency situation," Rantam noted here on Wednesday.

The Merah Putih Vaccine has currently enter the second phase of the clinical trial that starts from vaccine raw material creation development (upstream), vaccine formulation (downstream), and filling process into vials to become the finished product.

The second phase of the clinical trial involves 405 human subjects divided into three groups that will receive three mcg and five mcg doses of the vaccine.

Control vaccine will also be given through two administrations at an interval of 28 days.

The third phase of the clinical trial to determine the age group target type is planned to be rolled out starting from May 28, 2022.

"Ever since the pre-clinical trial, it has been prepared for children, teenagers, pregnant mothers, and parents," Rantam explained.

Under normal circumstances, the booster vaccine trial is conducted separately from the third phase of the clinical trial, he noted.

However, with the permit from the Indonesian Food and Drug Control Agency (BPOM) concerning the emergency situation, the booster trail can be conducted in parallel with the third phase.

"For instance, vaccine A is used as booster, that has its own research. However, due to emergency, it is sometimes allowed," Rantam noted.

The booster trial on Merah Putih Vaccine will apply the homologous method or similar vaccine platform with the primary complete dose for a more optimal result.

If the entire second and third phase of the clinical trial proceeds well, the BPOM targets the Merah Putih Vaccine to obtain Emergency Use Authorization (EUA) in August 2022 and be ready for the public. (*)