Brazil’s National Health Surveillance Agency reported a serious adverse event (SAE) on Oct. 29 in a study participant involved in the phase three trial of the Sinovac vaccine, leading to a decision to suspend the trial in the country. Pauses in clinical trials are common and were also seen previously in the phase three trials for AstraZeneca’s and Johnson & Johnson’s candidate vaccines.

In the latest development, Sinovac on Tuesday released a clarification of interruption in the phase three trial.

“We have noticed some media reports. After communicating with the Brazilian partner, the Butantan Institute, we’ve learned the head of the Butantan Institute believes that the SAE was not related to the vaccine. 

“Sinovac will continue to communicate with Brazil on this matter. The clinical study in Brazil is strictly carried out in accordance with GCP [good clinical practice] requirements and we are confident in the safety of the vaccine,” said Sinovac on its official website, sinovac.com.

Padjadjaran University’s (Unpad) team spokesperson Rodman Tarigan said the trial in Indonesia, which involves more than 1,600 volunteers, had yet to encounter an SAE.

Meanwhile, team leader Kusnandi said that all volunteers had received their first and second doses of the would-be vaccine.

“All shots have been administered. Now, we’re observing [for developments],” Kusnandi said in a virtual discussion on Lawan COVID-19 ID’s YouTube channel on Tuesday.

He further said that his team would take blood samples from the volunteers within two weeks or six months after they received the vaccine. The blood tests are conducted to assess how many anti-COVID-19 agents will appear, as well as to determine how effective and safe the vaccine is.

“Some of them are receiving a placebo, so we will compare the results to see how many volunteers injected with the placebo fall ill,” Kusnandi said.

In Indonesia’s trials, each volunteer who has received the first and second doses of the vaccine is under the team’s observation until March 2021.

State-owned pharmaceutical holding company PT Bio Farma plans to produce 16 to 17 million doses of COVID-19 vaccine per month, corporate secretary Bambang Heriyanto said on Oct. 19.

Indonesia needs 340 million doses of vaccine within a year to vaccinate around 60 percent of the population.

The government has secured deals to procure approximately 300 million doses of COVID-19 candidate vaccines from various developers, including China’s Sinovac Biotech Ltd. and China National Pharmaceutical Group (Sinopharm) as well as United Kingdom-based AstraZeneca.

Bio Farma has teamed up with Sinovac to launch the phase three clinical trials of the candidate vaccine in Bandung, West Java. (adi)

 

Editor’s note: This article is part of a public campaign by the COVID-19 task force to raise people’s awareness about the pandemic.