A House Of Representatives Member Asks To Dispose The AstraZeneca Vaccine If The Nusantara Vaccine Permit Is Troubled

Photo illustration (Source: Antara)

JAKARTA - Commission X House of Representatives (DPR) is surprised that the Food Drug Supervisory Agency (BPOM) has made it difficult to develop a domestically made Nusantara vaccine, which was initiated by former Health Minister Terawan Agus Putranto. In fact, the BPOM has just given an emergency permit to use the AstraZeneca vaccine from England.

The difficulty of granting the Approval for the Implementation of Clinical Trials (PPUK) for the II BPOM clinical trials to the Nusantara vaccine candidates, angered the DPR.

Member of Commission IX of the DPR Saleh Partaonan Daulay then asked BPOM to stop the issuance of emergency use permits (EUA) for all vaccine brands produced by foreign pharmaceutical companies. He considered that the BPOM was inconsistent in granting permission to use vaccines.

"I ask that every vaccine that comes to RI has the same protocol. Please don't use AstraZeneca first. If necessary, just throw it away and then send it home, even though it's a free vaccine. Because the protocol is not the same as yesterday's Sinovac", said Saleh at the Meeting at the Parliament Complex, Senayan, Jakarta, Wednesday 10 March.

Saleh then highlighted the AstraZeneca vaccine which was not through clinical trials in Indonesia but was successfully passed domestically. Meanwhile, homemade vaccines, such as the Nusantara vaccines, tend to make licensing more difficult.

In fact, according to Saleh, clinical trials with overseas populations do not guarantee that it will be suitable and safe to use for the Indonesian population.

"This is the turn for the Nusantara vaccines, why you make it difficult, while when foreign vaccines arrive in Indonesia, you entrusted the EUA to other countries?", he said sarcastically.

Therefore, the head of the PAN Party faction requested that vaccines from foreign products go through clinical trials such as that conducted by the Padjadjaran University Bandung research team which targeted 1.620 volunteers for vaccines from the Chinese company, Sinovac.

Saleh also accused BPOM of no longer being independent and of having double standards. Because, in the BPOM presentation, one of the reasons for the provision of PPUK for phase II clinical trials of domestic vaccines was not quickly given because pre-clinical trials on animals were carried out by the sponsor. In this case, the Nusantara vaccine is sponsored by AIVITA Biomedical from the United States.

"Earlier, animal research was not entrusted by other countries. While the EUA, which concerns the lives of people, we trust it to other countries, what is this?", Saleh concluded.

Head of BPOM Penny K. Lukito said that Indonesian vaccine research does not comply with medical standards. She emphasized that BPOM is independent and transparent which will support the procurement of national vaccines.

However, Penny also emphasized that the entire vaccine development process must pass scientific-based stages.

"BPOM will be transparent, we have no interest in covering anything up. But this is a scientific-based process", answered Penny.