Food and Drug Administration Admits The Nusantara Vaccine Made By Terawan Often Ignore Evaluation Results

JAKARTA - Head of the Food and Drug Administration (BPOM) Penny K. Lukito explained why they did not give permission for the COVID-19 Nusantara vaccine to conduct phase II clinical trials.

Penny said that the team of vaccine researchers by former Minister of Health Terawan Agus Putranto repeatedly ignored the results of the request and evaluation by the BPOM.

In fact, based on the results of phase I clinical trials by BPOM, the Nusantara vaccine is considered to have not met many rules of clinical trial stages, including good manufacturing practice and good clinical practice.

"Commitment correction action or prevention action has been requested from the beginning, but it was ignored, ignored, and ignored. Still can't, back to back. So various aspects, good clinical practice and good manufacturing practice for vaccine production have not been met", Penny said in a statement quoted on Wednesday, April 14.

Penny admitted that they have not passed the clinical trial phase I of the Nusantara vaccine, so they have not been able to get approval for phase II. Conceptually, the Nusantara vaccine is also not valid and the data is still incomplete.

Moreover, so far, there have been no reports of improvement from the Nusantara vaccine research team to the BPOM. "We have given the findings, when can give it? Until now we have not received anything", she said.

Penny then invited the research team of the Nusantara vaccine to make improvements related to procedures and rules in order to meet the approval of phase I clinical trials.

"We can not stop, please correct the proof of concept, the data needed for proof of validity, the validity of stage 1 clinical trials. Only then do we decide if we can step up", she explained.

Previously known, Vice Chairman of the House of Representatives of the Republic of Indonesia Azis Syamsuddin asked the Minister of Health (Ministry of Health) and the Food and Drug Control Agency (BPOM) to give the opportunity of the Nusantara vaccine to cover the shortage of COVID-19 vaccine stock that is increasingly thinning.

According to Azis, currently, the government needs to prioritize the production of domestic vaccines, such as the Nusantara vaccines so that it does not have to rely on other countries.

"The Nusantara vaccine is the work of our people, and certainly can facilitate the procurement of vaccines and more in accordance with the characteristics of the people of Indonesia", said Azis in his statement, Saturday, April 10.

The chairman of the Coordinating House of Representatives for Political and Security Affairs (Korpolkam) hopes that the government through the Ministry of Health and the BPOM can appreciate the hard work of domestic scientists and researchers in finding the Nusantara vaccine.

"The Nusantara vaccine is the finding of Indonesian scientists who are proof that Indonesia is able to make its own vaccine. It's a work of devotion to the state", the Golkar Party politician said.