Indonesia's Sinovac Covid-19 vaccine trial to continue, as Brazil halts theirs

Indonesia will not stop clinical trials for China's Sinovac coronavirus vaccine after Brazil suspended the late-stage trial on Monday, state-owned pharmaceutical company Bio Farma said on Tuesday.

Edwin G. Pringadi, a spokesman for Bio Farma which teamed up with Sinovac to conduct trials and eventually produce 16 to 17 million doses of the vaccine, said the trial, with 1,620 volunteers in the province of West Java, was "going smoothly".

Anvisa, Brazil's health regulator, on Monday said it had suspended the late-stage trial for the Chinese vaccine, citing "a severe adverse event", although it stopped short of elaborating on the incident, including when the trial could be resumed.

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A nurse administers China's Sinovac vaccine to a volunteer at a hospital in Porto Alegre, Brazil. File photo: Reuters

The Brazilian trial involved more than 10,000 volunteers and was the first of Sinovac's large late-stage trials to get under way. Turkey, Chile and Bangladesh are also conducting Sinovac vaccine trials.

Dimas Covas, the head of Sao Paulo's medical research institute Butantan which is conducting the trial, said the decision was related to a death. He found the regulator's announcement strange "because it's a death unrelated to the vaccine", Covas told local broadcaster TV Cultura, as quoted by Reuters.

Sinovac Biotech stood by the safety of its coronavirus vaccine, saying in a statement it was "confident in the safety of the vaccine", and that the adverse incident was "unrelated to the vaccine".

Doni Monardo, head of Indonesia's Covid-19 task force, declined to comment on vaccine-related queries, and Wiku Adisasmito, the task force's spokesman, did not respond to requests for comments.

The phase 3 clinical trial for Sinovac's coronavirus vaccine in Indonesia is set to deliver its preliminary result in January, according to Rodman Tarigan, a spokesman and a researcher with the clinical trial team in Padjadjaran University, who works together with Bio Farma in the trial.

The report will analyse whether immunogenicity - or the ability of the vaccine to provoke an immune response - is found in 540 individuals who have been twice injected with the vaccine in the clinical trial. The full report, which will determine the efficacy of the vaccine among all participants, is scheduled to be published in May next year.

A volunteer fills out a form to take part in a Covid-19 immunisation simulation in West Java, Indonesia. Photo: EPA-EFE

Responding to the news about the clinical trial suspension in Brazil, Rodman said that a suspension "is normal" in clinical trials for any vaccine.

However, Pandu Riono, an epidemiologist at the University of Indonesia, said that Indonesia's Sinovac vaccine clinical trial had to proceed with extra caution following the trial's suspension in Brazil.

"If it is found that there are fatal effects from the vaccine's clinical trial in Brazil, then Indonesia should cancel the trials here, but this is still uncertain now," said Pandu.

While it is common for clinical trials to be suspended, he urged Brazil's monitoring board to investigate the cause of death of the participant before resuming the trials. "What we fear is that he died from the vaccine, but if that's not the case then the trials can be resumed."

Worldwide, there are at least 10 coronavirus vaccine candidates in late-stage clinical trials, according to the World Health Organization (WHO). Four of them are from China. The suspension in Brazil is the first time any of China's candidates have met with this setback.

British pharmaceutical firm AstraZeneca's global Covid-19 vaccine clinical trials were briefly suspended in September after a participant in its UK trial developed a serious neurological illness. Its trial in Britain, Brazil, and South Africa resumed in the same month after auditors found no evidence that linked the illness with the vaccine. AstraZeneca works together with researchers from Oxford University to develop the vaccine.

Rodman said the clinical trial in West Java would proceed and that his team would strive to meet the May 2021 schedule to deliver their efficacy report.

"I've been involved in immunisation and clinical trials for [vaccines] for 10 years," he said. "I think [what is happening in Brazil] is a good thing for us. The Data and Safety Monitoring Board will review the causality between the death and the vaccine, this is very important for us. We will also be waiting for the board's report.

"For us, we will still want to meet our timeline, which is to finish the trial next year and deliver a full report about the efficacy of the vaccine in May 2021," he added.

According to Rodman, no participants had so far reported severe effects after being twice injected with Sinovac's vaccine.

"Some reported stiff muscles for two or three days. A participant reported allergies that caused them to sneeze in the morning, but apparently he already had the allergy before the vaccination. Some reported fever but not heavy fever where the body temperature reaches above 38 degrees Celsius," he said. "None of the complaints disrupt the participants' daily activities."

Indonesia, which has 270 million people and over 444,000 coronavirus cases, secured vaccines from three Chinese producers following a meeting between the representatives of Indonesian government and CanSino, Sinopharm, and Sinovac in early October.

Tianjin-based CanSino has pledged to supply 100,000 single-dose vaccines this month and expects to deliver between 15 million to 20 million doses next year, while Sinopharm is expected to deliver 15 million dual-dose vaccines this year, with 5 million doses planned to be delivered this month. Sinopharm will also supply 50 million double-dose vaccines next year.

Sinovac has said it will supply 125 million double-dose vaccines next year. Photo: AFP

Meanwhile, Sinovac has promised to deliver 3 million doses by end of this year, with 1.5 million single-dose vials to be delivered this month, and the rest is set to be supplied next month. The Beijing-based company said it will supply 125 million double-dose vaccines next year.

Last month, Indonesia signed a letter of intent with AstraZeneca to secure 100 million doses of its vaccines in 2021.

The Southeast Asian nation is also developing its own coronavirus vaccines, named "Merah Putih", that are planned to be mass-produced by Bio Farma in 2022. President Joko Widodo has aimed that the country would get around 290 million doses of coronavirus vaccines next year.

Luhut Pandjaitan, coordinating minister of maritime and investment affairs, earlier this month announced at a dialogue that the country would start emergency inoculation in "third week of December".

But Pandu, the epidemiologist, said that the minister does not have the authority to set the date for safe vaccination, as it is the authority of the country's Food and Drugs Agency, or BPOM.

Additional reporting by Reuters

This article originally appeared on the South China Morning Post (SCMP).

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