Unair's Merah Putih Vaccine Undergoes Phase 1 Clinical Trials Early December

PIXABAY ILLUSTRATION

JAKARTA - The candidate for the Merah Putih vaccine developed by Universitas Airlangga (Unair) is targeted to undergo phase 1 clinical trials on humans in early December.

"Our hope is that in early December 2021, phase 1 clinical trials will begin and also coincide with phase 2, possibly until March 2022," said the head of the Merah Putih Vaccine research team at Airlangga University, Fedik Abdul Rantam, quoted by Antara, Wednesday, November 10.

After clinical trials phase 1 and 2, proceed to phase 3, and by July 2022 it is hoped that the Merah Putih Vaccine will have obtained an emergency use authorization or EUA from the Food and Drug Administration (BPOM).

Unair developed the Merah Putih vaccine for COVID-19 using an inactivated virus-based platform.

Fedik said that the Merah Putih Vaccine seeds had already passed phase 1 and 2 preclinical trials, and did not go through phase 3 preclinical trials.

"The phase 2 preclinical test has been completed, then we prepare vaccine seeds for pilot scale," he said.

The first phase of the preclinical test used mice and the second phase used macaques or monkeys.

Currently, preparation of vaccine seeds is being carried out to be ready for injection into humans to start phase 1 clinical trials.

Unair has handed over the vaccine seeds to PT Biotis Pharmaceuticals Indonesia to be prepared for the implementation of the vaccine clinical trial.

For the time being, the clinical trial was conducted at the Doctor Soetomo Regional General Hospital, Surabaya, East Java.

After successfully going through phase 1, 2, and 3 clinical trials, BPOM will evaluate the results and determine whether the vaccine is licensed for emergency use or not.

If you have received EUA from BPOM, then the vaccine can be mass produced and given to the public.

The mass production of the vaccine will be carried out by PT Biotis Pharmaceuticals Indonesia.

Previously, Minister of Health Budi Gunadi Sadikin said the results of the pre-clinical test of the vaccine seeds showed high efficiency, and PT Biotis would then conduct clinical trials to check the safety and benefits of the vaccine.

He said the phase 1 clinical trial aims to test the safety of the vaccine and will be carried out on 100 people.

Phase 2 clinical trials to see the immunogenicity of the vaccine will be conducted on 400 people.

While phase 3 clinical trials to test the efficacy of the vaccine will involve about 3,000 people.