At the beginning of this week, BioNTech CEO Ugur Sahin announced plans to set up a  Southeast Asia headquarters in Singapore, where it will build a production facility for mRNA vaccines and other drugs to treat infectious diseases and cancer. The new site, he said, will have capacity to make hundreds of millions of vaccine doses annually, starting as early as 2023. With the new facility, the biotech would be able to scale up production in the region to be prepared for future pandemics.

BioNTech’s expansion is being supported financially by the Singapore Economic Development Board, which in past years has backed hundreds of new industrial projects, for the most part at Jurong Island, one the world’s largest integrated chemical production hubs.

“Having multiple nodes in our production network is an important strategic step in building out our global footprint and capabilities,” Sahin said, adding that the planned investment will increase BioNTech’s overall network capacity and expand its ability to manufacture and deliver mRNA vaccines and therapies worldwide. Last year, the company set up a US headquarters in Cambridge, Massachusetts. It has also established a marketing company in Turkey, its founders’ native country.

Expansion in China with Fosun

In another Asian move, BioNTech is in establishing a 50:50 joint venture with its Chinese marketing partner Fosun to offer the German company’s Covid vaccine in the People’s Republic. The jv could produce up to 1 billion doses a year, according to Fosun’s filing with the Hong Kong Exchange. The jv is conceived for a period of 15 years, during which it can be expanded. The Chinese drugmaker is contributing up to $100 million of assets in cash and a production facility, while BioNTech has pledged $100 million in the form of proprietary manufacturing technology and knowhow.

BioNTech first linked up with Fosun in March 2020, granting the partner an exclusive licensing agreement for the Chinese market. The It has been providing the vaccine for local clinical trials and for ongoing commercial rollout in Hong Kong and Macau. Comirnaty has not yet been approved by Chinese authorities, but Sahin said earlier the green light was expected for July this year. Sources speaking to the newspaper Wall Street Journal said, however, that the government’s nod may be contingent on approvals for Chinese vaccines abroad.

Despite its massive rollout in the US and Europe, the BioNTech/Pfizer vaccine has not made deep inroads into markets in other regions. In China, it is still in a phase 2 bridging study, launched in August 2020. Reports said data from this trial will be combined with existing efficacy data from the shot’s global phase 3 for a Chinese application. If approved as planned, Comirnaty would be the first foreign-made Covid vaccine available in China.

FDA Approves Comirnaty for Adolescents

The US Food and Drug Administration meanwhile has granted an Emergency Use Application for Comirnaty to be given to adolescents aged 12 to 15. This will allow a rollout to begin immediately and be completed before the end of school vacations in late summer or early autumn. This is contingent on the Centers for Disease Control and Prevention’s vaccine advisory committee nodding off on the approval as expected.

Following a clinical trial with more than 2,000 adolescents, Pfizer and BioNTech said in late March that the vaccine was shown to be 100% effective in that age group, eliciting a “robust” antibody response that was better than that seen in an earlier trial of older teens and young adults. In late March, the partners started a clinical trial testing their vaccine in healthy 6 months to 11-year-old children.

Author: Dede Williams, Freelance Journalist