Joanito De Saojoao & Heru Andriyanto, Jakarta – President Joko "Jokowi" Widodo is unhappy with the growing number of politicians and other prominent figures voicing their support for a homegrown Covid-19 vaccine, which has failed to obtain government approval.
The so-called Nusantara vaccine is championed by former health minister Terawan Agus Putranto with support from many top politicians who have volunteered in the initial trial.
However, the Drug and Food Supervisory Agency (BPOM) said it won't approve its public use, citing failure to meet good clinical practice. In response, lawmakers involved in the trial accused the agency of lacking of nationalism and summoned BPOM Head Penny Lukito for a hearing.
"Why is there a noise? This is a matter of scientific research. Why are those politicians and lawyers debating about vaccine making?" the president told reporters in Jakarta on Tuesday.
"There are stages [in vaccine development] that must be followed but what we get is the noise. Some support the BPOM while others support Mr. Terawan."
The president indicated that another homegrown candidate vaccine gets the government's favor amid mounting controversies concerning the Nusantara vaccine.
Jokowi pointed to the ongoing project between state agencies and private research institutions in developing the Merah Putih vaccine, named after the colors of the national flag. The project is expected to deliver result next year, he said.
"The government fully supports any research and development intended to break the cycle of the Covid-19 outbreak," Jokowi said.
How Nusantara vaccine works
The Nusantara vaccine uses dendritic cells previously loaded with the spike protein of SARS-CoV-2, the virus that causes Covid-19.
A summary of the method has been published on the United States National Library of Medicine's website under the title "Dendritic Cell Vaccine to Prevent Covid-19".
It collects 50 ml of patient's blood, "from which peripheral blood monocytes will be isolated and differentiated into dendritic cell before incubation with SARS-CoV-2 spike protein", the article reads.
This resulted in a vaccine to be injected into the particular patient about seven days after the incubation process.
The US website carries a disclaimer: "The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government."
The study mentioned the Indonesian Health Ministry as the sponsor, in collaboration with US-based pharmaceutical company Aivita Biomedical Inc., Diponegoro University's faculty of medicine and Dr Kariadi Hospital – both are located in Semarang, Central Java.
It was posted on Dec. 28, six days after Terawan was dismissed from the cabinet. Given the current development, it's very unlikely that the Health Ministry remains in charge of the Nusantara vaccine project.
Adverse effects
At least seven members of the House of Representatives' Health Commission and House Deputy Speaker Sufmi Dasco Ahmad participated in the trial earlier this month.
Several other prominent figures such as former Armed Forces Commander General (ret.) Gatot Nurmantyo and former Golkar Party Chairman Aburizal Bakrie have had their blood sample taken for the trial. Both names are widely considered as political opponents of the president.
Penny, the BPOM head, said the trial was conducted without the agency's consent.
In a statement issued last Thursday, Penny said 71 percent of 28 volunteers in the trial had experienced adverse reactions such as muscle pain, headache, fever, rashes, sore throat, cough and nausea.
At least three volunteers saw unusual rise of cholesterol level and one volunteer suffered hypernatremia or high concentration of sodium in the blood after having a shot, she said.
"When the BPOM made an inspection, the research team informed that the clinical trial was not immediately ceased despite those incidents," Penny said.
During the April 8 hearing with lawmakers, Penny rebutted any topic about nationalism, saying it was foreign researchers from Aivita who dominated discussions with BPOM officials regarding the initial trial.
"Doctors from Kariadi Hospital have been trained but they just observed [the trial] without direct participation," she told the hearing.
The candidate vaccine also used imported materials at a very high price, she said without providing any detail.
Source: https://jakartaglobe.id/news/president-slams-noisy-debate-on-homegrown-covid-vaccin