‘Not guinea pigs’: Indonesian officials debunk rumours, defend safety of Bill Gates-backed TB vaccine trial
Debate surrounding the M72 tuberculosis vaccine candidate arose after Indonesian President Prabowo Subianto’s remarks following his meeting with philanthropist Gates, the Microsoft co-founder.
JAKARTA: The late-stage trial of a tuberculosis (TB) vaccine backed by Microsoft co-founder Bill Gates and involving over 2,000 Indonesians is safe and will bring benefits to the country, health officials said in the wake of conspiracy theories surrounding the vaccine.
Controversy, including reported rumours and misinformation surrounding the M72/AS01E vaccine candidate, arose after Indonesian President Prabowo Subianto’s remarks following his meeting with American philanthropist and Gates in Indonesia on May 7.
Prabowo said Gates was “developing a TB vaccine for the world” and that Indonesia would be “one of the places to test” the vaccine.
The president also praised Gates’ contributions to the country, noting that his foundation had provided more than US$159 million in grants since 2009, mostly for health programmes.
However, in the wake of Prabowo’s comments, netizens expressed doubts about Indonesia being the “testing ground” for the vaccine candidate. They questioned Gates’ intention and why it was only being tested in “poor countries”.
Indonesia is the only country outside Africa to take part in the trial.
VACCINE CANDIDATE IS SAFE: INDONESIAN AUTHORITIES
Participating in the trial means Indonesians will be among the first to receive the TB vaccine, said Taruna Ikrar, head of the country’s Food and Drug Supervisory Agency (BPOM), on Wednesday (May 14), as reported by news agency Antara.
Vaccination is one of the most effective strategies to reduce TB prevalence in the country, he said. According to the World Health Organization (WHO), the estimated incidence of TB in Indonesia was 387 per 100,000 population in 2023.
Indonesia sees over 1 million TB cases a year and was estimated to have the world’s second-highest number of TB cases in 2023, after India.
It accounted for 10 per cent of an estimated 10.8 million cases globally in 2023, according to the WHO’s Global TB Report 2024. Indonesia recorded about 125,000 deaths from TB in 2023, according to Taruna.
TB is an airborne infectious disease caused by a bacterium called Mycobacterium tuberculosis, and primarily affects the lungs. It can cause lung damage or death if untreated.
The WHO has called M72 the most advanced TB vaccine candidate in development.
Taruna said the vaccine to be trialled is safe, having undergone pre-clinical testing, toxicity studies and safety trials in line with international standards.
“Based on scientific evaluations, we have authorised the clinical trials of the TB vaccine in Indonesia,” he told Antara. “There is no issue here. The TB vaccine will bring many benefits.”
Health Minister Budi Gunadi Sadikin also assured the vaccine is safe.
“This is to educate the public, as well, that we are not guinea pigs,” he reportedly said on May 9.
Rumours about the vaccine were “intentionally spread so that people do not want to be vaccinated. In fact, the consequences can be very fatal, 100,000 people could die because of something like this,” Budi said on May 9.
On Wednesday, Budi said the trial will help determine the vaccine’s compatibility with Indonesia’s population, as vaccine effectiveness can depend on genetic factors, reported news outlet Tempo.
He said the trial involves scientists at Padjadjaran University and the University of Indonesia.
If successful, Indonesia could eventually serve as a manufacturing site for the vaccine, he said.
Dr Windhu Purnomo, an epidemiologist from East Java's Airlangga University, said given the prevalence of the disease in the country, it is important for Indonesia to participate in the quest for a more effective vaccine against TB.
"Currently, the only available vaccine for TB is the BCG vaccine, whose effectiveness in adults is very limited," Windhu told CNA, referring to the Bacille Calmette-Guerin vaccine which was developed more than a century ago.
Windhu noted that although Indonesia's 1 million cases a year is lower than India's 2.7 million cases, India's 1.4 billion population is five times that of Indonesia's 281 million.
"This means Indonesia's TB prevalence is higher than India's. Furthermore, in Indonesia one in 10 TB cases resulted in death. That is alarming. Indonesia needs this new vaccine," he said.
Windhu dismissed the concerns aired by some Indonesian netizens that the vaccine may not be safe.
"A vaccine's safety is tested during the pre-clinical trial and the first two (phases of) clinical trials. The fact that we are in Phase 3 means that the vaccine is already considered safe and all that is left to test is how effective this vaccine is,” he said.
INDONESIA INVOLVED IN TB VACCINE TRIAL SINCE 2024
The M72 is developed by pharmaceutical firm GlaxoSmithKline in partnership with AERAS, a United States-based not-for-profit funded by the Bill and Melinda Gates Foundation and other organisations.
Indonesia’s involvement in the late-stage trial has been known since last year.
New vaccines are urgently needed to tackle TB in Indonesia and globally, the WHO said in a news release in November 2024 when it convened the first national consultation on new TB vaccines together with Indonesia’s Ministry of Health in Bali.
If M72’s efficacy is confirmed in the late-stage trial, it could lead to the introduction of a new TB vaccine for adults and adolescents by 2030, said the WHO.
The Phase 3 trial involves 20,000 participants from five countries.
Besides the 2,095 people from Indonesia, the rest are from South Africa, Kenya, Malawi and Zambia. Africa had the second-highest number of TB cases in 2023 after Southeast Asia, according to the Global TB Report 2024.
The earlier Phase 2b of the trial involved more than 3,500 people in South Africa, Zambia and Kenya, and results were “cautiously encouraging”, reported an article on May 13 by Gavi, the Vaccine Alliance, a global health partnership.
“In these adults, who were already thought to have been infected with the bacterium (TB bacteria can remain dormant for many years), the vaccine halved the risk of developing active TB over the next three years compared to a placebo, with an estimated efficacy of 50 per cent,” it reported.
The rumours in Indonesia about M72 are not the first time that conspiracy theories related to public health and Gates have arisen in the country.
In 2023, misinformation about Wolbachia mosquitoes stoked protests and delayed the rollout of a project in Bali that involved their release to fight dengue. The project involved the World Mosquito Programme, which is supported by the Bill and Melinda Gates Foundation.
Additional reporting by Nivell Rayda
