HONG KONG – Biotech companies with COVID-19 vaccine candidates are collaborating with Indonesian companies for overseas trials and to ensure wider availability when approved. Beijing-based Sinovac Biotech Co. Ltd., for example, is collaborating with Indonesia’s state-owned vaccine manufacturer PT Bio Farma to test and manufacture its vaccine candidate there. Bio Farma aims to begin its trials of Sinovac’s Coronavac in July.
Sinovac will provide the formulation, technology and active pharmaceutical ingredients (API) for Bio Farma to develop, test, manufacture and distribute a vaccine in Indonesia.
Even though Bio Farma has strong manufacturing capacity, it may not have the expertise to develop a COVID-19 vaccine as rapidly as Sinovac, which recently reported positive preliminary data from its phase I/II trials.
Sinovac plans to submit the results to China’s National Medical Products Administration (NMPA) and set the protocols for a phase III study in China as well as in other countries like Indonesia, Canada and Brazil.
Bio Farma hopes to start commercializing the vaccine in Indonesia during the first quarter of 2021. It is also working on a novel vaccine with the Eijkman Institute for Molecular Biology based in Jakarta, but that will not be ready for distribution until the end of 2021 at the earliest. The company has also applied to the Coalition for Epidemic Preparedness Innovations (CEPI) to hold trials and build capacity in the country of another possible vaccine.
It has partnered up with PT Kalbe Farma Tbk for the trials in the Southeast Asian country. The pair already shares a joint venture company, PT Kalbe Genexine Biologic, which develops and makes materials for biotech medicines in Indonesia.
“The COVID-19 vaccine development collaboration is Kalbe's contribution to helping the government to overcome the COVID-19 pandemic in Indonesia,” said Sie Djohan, the director of Kalbe Farma.
“Kalbe hopes that through these research and development efforts the vaccine will be able to get quick results, thus the availability of vaccines in Indonesia can be guaranteed,” he said.
Indonesia is the world’s fourth most populous country and there are concerns that there may not be enough supply to meet its needs. The Indonesian Coordinating Minister of Economic Affairs estimates that the country needs to secure a minimum of 340 million ampoules of a COVID-19 vaccine to treat around 170 million people, about two-thirds of the country's total population.
“Our production facility can handle up to 2 billion dosages, so we should be able to produce sufficient quantities of vaccine by ourselves,” said Honesti Basyir, Bio Farma’s president and director, during a commission of the House of Representatives hearing in April.
Companies such as Sinovac are preparing increase their manufacturing capabilities.
“We have started to invest in building a manufacturing facility so that we can maximize the number of doses available to protect people from COVID-19,” said Yin Weidong, Sinovac’s chairman, president and CEO. “As with our other vaccines, we are committed to developing Coronavac for global use.”
Other companies with possible COVID-19 vaccines are also on the lookout for partners abroad. One of them is Beijing-based Yisheng Biopharma Co. Ltd.
“If COVID-19 is going to be around for the next few years, definitely it’s impossible for a single company or just a handful of them to handle this kind of demand at the global level,” David Shao, the CEO of Yisheng, told BioWorld. “I estimate that, even in China, we need at least 10 vaccine producers for such significant scale production capacity. It definitely requires a joint effort by many players from different countries,” he added.
Yisheng is also considering going overseas to test and manufacture its vaccine. It has a manufacturing plant in Singapore that is in the early stages of design.
“We’re actively looking for partners from different locations such as the U.S., Europe or other countries. We think this is going to be multicountry effort. We want to work together with other partners in not only clinical development, but also manufacturing and commercialization,” said Shao.
He said he sees COVID-19 as a global challenge that requires all kinds of collaborative efforts.
“Chinese companies are collaborating with other players and conducting clinical trials outside of China,” said Shao. “This paves the way for clinical achievements that can eventually benefit the global population.”