By: Ainur Rohmah
The Indonesian government, which has badly misplayed its response to the Covid-19 pandemic, is looking to clinical trials of a vaccine developed in cooperation with the China-based biopharmaceutical company Sinovac Biotech, generating concerns that officials will rush out an immunization process without proper testing.
As of July 21, the country had experienced nearly 90,000 infections and 4,320 deaths, both the highest in Southeast Asia. Cases and deaths doubled after almost a month of faltering steps to guard against the virus while reopening an economy prematurely that could hardly be said to have been closed. Community disobedience, lack of testing and a large population have worked together to make Indonesia a potential new coronavirus epicenter, critics say. Some 81 people died overnight.
Driven by a demand from President Joko Widodo to develop a vaccine within three months, Cabinet Secretary Pramono Anung said the government hopes to begin mass-production by December or January although health officials in developed countries have expressed doubt that any timetable like that is possible. Kenneth Frazier, the CEO of the pharma giant Merck & Co, for instance, warned on July 15 that the many vaccines now under development are not guaranteed to work and that those who expect a vaccine before year-end are doing a “grave disservice to the public.
Nonetheless, “If this (vaccine test) can be approved in December or January, we will immediately produce (vaccine) on a large scale,” Pramono said. “Later this vaccine will be distributed to all provinces with a priority of eight provinces affected by the most severe outbreaks.”
However, Home Minister Tito Karnavian cautioned that even if the vaccine is tested successfully in Indonesia, a country with a population of around 270 million, other time-consuming stages remain such as production and distribution. Indonesia will need at least 170 million doses to cover two-thirds of its population, the level at which so-called ‘herd immunity” is reached.
The government must also distribute the vaccines to all corners of a country spread over 17,000 islands extending for more than 5,000 km including remote areas which are limited in terms of transportation and medical personnel. In addition, the inoculation process requires trained adequate medical personnel whereas the ratio between health workers and total population is very small.
Also, Kusnandi Rusmil, the head of the clinical trial team, urged caution, saying the trial process can’t be completed before January. The team refused President Joko Widodo’s request to have them completed within three months.
“A special direction from the President is that we are trying to make the corona vaccine available immediately. If possible (the trials) in three months,” said Kusnandi, a professor of pediatrics at Padjajaran University, after meeting with Jokowi. “We said we could not (complete the research) in three months because we have to do it carefully and correctly,”
Although vaccines are urgently needed, Kusnandi said, researchers will not be rushed and be very careful in conducting these clinical trials. “For medical clinical trials, there are procedures that have been regulated by the World Health Organization. It should not be rushed. Because it is feared the results are not good, and side effects and benefits are not monitored,” Kusnandi said.
Another source pointed out that Indonesia has had very little experience with clinical trials, almost zero in recent years. Nonetheless, despite the reservations of epidemiologists, the Indonesian state-owned pharmaceutical company Bio Farma is expected to conduct a third phase of clinical trials, or large-scale testing on humans, the last step before regulatory approval, beginning in August and scheduled to last for six months. Some 2,400 Sinovac-made vaccines are to be tested on about 1,620 people and the rest will be tested in the laboratory.
Bio Farma president director Honesti Basyir said the company had prepared a production facility with maximum production capacity of 250 million doses. “This phase 3 clinical trial is to determine the safety, efficiency, and immunogenicity of vaccines,” Honesti said. “If the clinical trial goes well, then Bio Farma will produce it in the first quarter of 2021.”
Honesti said the trial would commence soon in cooperation with Padjajaran University in Bandung, West Java, as well as the Health Ministry’s research and development agency. His agency chose Sinovac as a partner, he said, because its method of making vaccines is in accordance with the competencies of the current Bio Farma. In addition to Indonesia, the phase 3 trials are also being conducted in Brazil, Turkey, Bangladesh, and Chile.
The Indonesia project is one of the three most advanced of the dozens worldwide by scientists racing to develop and test the vaccine. Besides Sinovac, other virus candidates are also under development by Oxford University in Britain, the Swiss firm AstraZeneca AG, and China’s state-owned Sinopharm.
Data from the Ministry of Health shows that in 2014, as many as 48 percent of health workers were concentrated in Java and Bali, numbering 435,877 people. In the easternmost province of Papua, health workers number only around 2 percent, or 18,332 workers.
“If a vaccine is found then the pandemic is finished. The question is, who can guarantee when this (vaccine) is found?” Tito asked in a speech at the 2020 regional election readiness coordination meeting. “We pray the vaccine that was discovered by Sinovac matches with the virus here,” said Tito, given the difference in sequences between the SARS-CoV-2 viruses found in China, America, and Europe.
While a vaccine has not yet been found, Tito said, he expressed a hope that the virus can be further weakened due to mutations so that no more victims die.
Covid-19 mortality rates in Indonesia are estimated to be three to four times the official government figures, with 68 doctors so far dying of Covid-related illnesses according to data from the Indonesian Doctors Association.
The government is in a dilemma between the need to contain the epidemic and the difficulty of enforcing isolation for millions who have to work to eat. The country has continued to experience a surge of infections and deaths in the wake of a decision by the central government and local administrations to gradually lift requirements under large-scale social restrictions (PSBB) in the first weeks of June. Many of the new confirmed COVID-19 cases were found in office settings with poor air circulation and workers who were not wearing masks.
The government recently launched a new joint Covid-19 response team to tackle both the public health and economic aspects of the pandemic, but some see this as a signal that the government is more concerned with the economic aspects than overcoming the plague. The economic recovery and mitigation team will be led by Coordinating Economic Minister Airlangga Hartato as chairperson and State-Owned Enterprises (SOEs) Minister Erick Thohir as executive chairperson.
Pandu Riono, chief epidemiologist at the University of Indonesia (UI), criticized government policies that tend to prioritize economic aspects rather than focus on suppressing the spread. “We should overcome the pandemic first, so that the economy will recover. If not, both fail, the pandemic is not resolved, the economy will also be increasingly difficult to recover,” he said.
Epidemiologists warn that the number of tests is still far below the minimum standard set by the WHO of 54,000 people per day referring to the total population. However, the country has only been able to conduct tests on 20,000 specimens. Its rate of 4,500 tests per million population is the lowest in Southeast Asia.
The positivity rate is very high, reaching 12.2 percent, far from the 5 percent safe threshold set by the WHO. When compared with China, for example, Indonesia only examined around 670,000 people per Tuesday and found 84,882 people of them were positive. China has conducted tests to at least 90 million people and found only 83,644 were positive.
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