BioNTech revenues boosted by COVID-19 vaccine programs

BERLIN, Nov. 10 (Xinhua) -- German pharmaceutical company BioNTech SE announced on Tuesday that its revenues climbed to 136.9 million euros (161.7 million U.S. dollars) in the first nine months of the year, compared with 80.6 million euros in the same period last year.

The development of revenues was driven by new collaborations with U.S. company Pfizer and China's Fosun Pharma within the BNT162 vaccine program against COVID-19, according to the German company.

"We have initiated the first rolling regulatory submission processes for our COVID-19 vaccine program in the EU (European Union), the UK and Canada and we are continuing to work with our partners to scale-up production capacity to prepare for a potential global launch of our COVID-19 vaccine, if approved," said Ugur Sahin, chief executive officer (CEO) of BioNTech, in a statement.

In August, BioNTech and China's Fosun Group already started a Phase 1 study to evaluate safety and immunogenicity of the vaccine candidate in Chinese participants. BioNTech is expecting to start a Phase 2 clinical trial in China by the end of the year, once regulatory approval from China's National Medical Products Administration (NMPA) was granted.

On Monday, BioNTech and Pfizer announced that their vaccine candidate showed more than 90 percent efficacy in protecting against COVID-19 in volunteers with no proven previous SARS-CoV-2 infection.

Furthermore, no serious side effects had been observed based on first interim results from the ongoing Phase 3 clinical study conducted by an external, independent Data Monitoring Committee (DMC), according to a joint statement by the companies.

"Yesterday's announcement regarding the first interim analysis from our global Phase 3 trial for our COVID-19 vaccine candidate, BNT162, is a watershed moment for both our company and scientific innovation," stressed Sahin.

BioNTech and Pfizer are planning to submit their potential COVID-19 vaccine candidate for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) in the third week of November.

For the development of a COVID-19 vaccine, BioNTech received 375 million euros from a special vaccine development program by the German government. The progress made by BioNTech and Pfizer was "very encouraging," German Minister of Health Jens Spahn said during a press conference on Monday.

Spahn emphasized that the European Commission had the mandate to negotiate with pharmaceutical companies at the European level. In a statement issued on Tuesday, the Commission said it will authorize on Wednesday a contract for up to 300 million doses of the vaccine developed by BioNTech and Pfizer.