JAKARTA - Head of the Food and Drug Control Agency (BPOM) Penny K. Lukito opened up about The Nusantara Vaccine developed by the former Minister of Health (Menkes), Terawan.
During this time BPOM often give a lot of input what is lacking in the development of the vaccine. Unfortunately to this day, the development team of Vaksin Nusantara has not given a report of improvement.
"We have given the findings, when they can give until now we have not received," Penny said in an electronic message received by reporters, Wednesday, April 14.
It is for this deficiency that BPOM has not given permission for Vaksin Nusantara to enter the phase II clinical trial stage. Conceptually, penny admitted, Nusantara vaccine is also not valid and the data is still incomplete.
The results of the phase I clinical trial of Vaksin Nusantara 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 ignored, ignored, ignored. Still can't, back to back. So various aspects, good clinical practice and good manufacturing practice for vaccine production have not been met," said Penny.
Penny then invited the nusantara vaccine research team 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, validity of stage 1 clinical trials. Only then do we decide if we can step up," he 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 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 nusantara vaccines so that it does not have to rely on other countries.
"Vaksin Nusantara is the work of the nation's children, 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 BPOM can appreciate the hard work of domestic scientists and researchers in finding nusantara vaccines.
"Vaksin Nusantara is the finding of Indonesian scientists who are proof that the Indonesian nation is able to make its own vaccine. It's a work of devotion to the state," the Golkar politician said.
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