Phase 3 CoronaVac Trial in Indonesia Moves Along while BPOM Plans an Audit of Sinovac Facility in China

Phase 3 CoronaVac Trial in Indonesia Moves Along while BPOM Plans an Audit of Sinovac Facility in China TrialsiteN

Thus far, Indonesian authorities report the relatively smooth running of the Phase 3 Sinovac COVID-19 clinical trial vaccine candidate. Conducted in Bandung, West Java, the local press reports no participants with “grave symptoms” after the injections. Retno Marsudi, Indonesia’s Foreign Minister, commented that “The clinical trials have, so far, run smoothly, and we did not receive any report on those experiencing serious side effects. It means that the clinical trials have run smoothly with good results.” Sinovac monitors have been observing this clinical, which started in August, at the trial site at state pharmaceutical company PT Bio Farma. In a signal that Indonesia considers the next move (approval), a BPOM delegation plans a trip to audit the Sinovac facilities in China.

Sinovac is conducting this Phase 3 clinical trial in Indonesia in addition to other countries. Local news such as Antara offers updates. The study effort in the world’s fourth most populated nation means that they are that much closer to a COVID-19 vaccine. With 282,724 reported cases and 10,601 deaths, Indonesia hasn’t been totally spared but has avoided the impacts felt by other large nations such as the United States, India, and Brazil.

Production Capacity Grows

Bio Farma reports it increased its production capacity from 100 million doses to 250 million doses of the COVID-19 vaccine known as CoronaVac.

BPOM to Audit the Sinovac

In parallel, a delegation from the Indonesian Food and Drug Monitoring Agency (BPOM) will drop in on Sinovac facilities in China as part of the government’s quality assurance or “precautionary measures” to prepare for actual commercial use of the vaccine in Indonesia, reported the Jakarta Post.

Padjadjaran University Treats the Governor and Many Volunteers

On August 30, 2020, a trial site location updated local news ANTARA that the Padjadjaran University site investigational team had treated 248 volunteers, including West Java Governor Ridwan Kamil. Also involved with the Phase 3 trial are a number of trial sites where volunteers receive the vaccine injections, such as community health centers like Unpad’s Health Center and Faculty of Medicine, as well as Garuda, Ciumbuleuit, Dago, and Sukapakir Public Health Centers.

Next Steps

This pivotal Phase 3 clinical trial, if successful, will lead to the decision at the desk of BPOM. If the regulator offers a thumbs up, then the vaccine is ready for mass production by PT Bio Farma, the state-owned pharmaceutical company.

BPOM

The Indonesia Food and Drug Authority, or Indonesia FDA, is called Badan Pengawas Obat dan Makanan, or Badan POM (BPOM), a government agency responsible for protecting the public health through the control and supervision of prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, dietary supplements, food safety, traditional medicine, and cosmetics. Formed in 1936, the agency is based in Central Jakarta.

Clinical Research in Indonesia

TrialSite shared its high-level tour of clinical research in Indonesia titled “Clinical Trials in the Indonesia Archipelago: Enter the Pristine Waters Slowly and Carefully.” Note that local news reports that Indonesia is also working on a home-grown vaccine for COVID-19 named after the national flag (Merah Putih). The Indonesian government recently claimed that the vaccine candidate recently reached 50 percent and would be ready sometime next year.

About Sinovac

Sinovac Biotech Ltd, a biopharmaceutical company focusing on the research, development, and manufacture and commercialization of vaccines that protect against human diseases, is based in Beijing. Its CoronaVac is a leading candidate targeting COVID-19. Founded in 1999, TrialSite has reported known issues for investors to monitor in regards to company behavior.