Indonesia’s Bio Farma, a state-run pharmaceutical company, plans to produce 100 million doses of COVID-19 vaccine product developed by Sinovac. In a deal that is contingent on a successful Phase 3 clinical trial in the world’s third most populous nation, Sinovac has commenced Phase 3 trial in Brazil and now Indonesia participates in this pivotal study of up to 1,620 volunteers testing CoronaVac.
COVID-19 in Indonesia
Indonesia is up to 93,657 cases and 4,576 deaths. The virus has spread to all of the country’s 34 provinces. Although not nearly as bad as many other nations, they experienced their highest count of COVID-19 cases recently. The country had economic problems before, and the implications of COVID-19 lockdowns and slowdowns will affect the Indonesia Archipelago of 273 million people. Now the country’s leadership has taken steps to protect its people, reports the Jakarta Globe. But are they selecting the right vaccine?
The Experimental Vaccine
Sinovac Biotech Ltd describes its CoronaVac as a SARS-CoV-2 vaccine candidate based on an inactivated pathogen. The virus is grown in a lab and then killed or deactivated. Brazil has selected CoronaVac, commencing with a Phase 3 clinical trial targeting 9,000 participants. In June, the company reported positive preliminary data from the Phase I/2 CoronaVac clinical trial.
The Phase 3 Study
China’s Sinovac has secured another nation testing its phase 3 study: first Brazil and now the world’s fourth most populous, Indonesia. Sinovac has shipped 2,400 doses to Bio Farma as Indonesia ramps up a study. Bio Farma must conduct tests on the vaccine prior to the initiation of the trial, hence why the study doesn’t start until early August.
According to the country’s president’s tweet, “We will be conducting Phase 3 clinical trials of the COVID-19 vaccine involving 1,620 volunteers. The process and protocol will be closely monitored and guided by the BPOM [Drug and Food control Agency].” They expect the entire investigational process to span August 3, 2020 till the new year.
The Research Site
Padjadjaran University’s Medical Faculty in Bandung West Java will be the nexus of the Phase 3 clinical trial serving as the investigational site for the testing of CoronaVac. This academic medical center will lead the 1,620 subject trial involving subjects between 15 and 59 and other inclusion criteria.
Assuming the Phase 3 goes well, Indonesia has negotiated an option to purchase the vaccine. Their president claimed that Bio Farm could make 100 million doses per year. Upon approva,l Bio Farma will commence manufacturing “at scale” in Q1 2021. Honesti Basyir, the company CEO, reported on the company’s website that they have the capacity to make 250 million doses. They are prepared to make 40 million doses in the first stage of production before moving to 100 million batches.
Investor Problems with Sinovac
TrialSite has reported on investor challenges with Sinovac. The company recently secured a $15 million convertible debt deal. In 2019, the company initiated a rare “poison pill” to project management from disgruntled shareholders. The whole affair was full of intrigue and drama.