Back in January, BioNTech CEO Uğur Şahin read an article in The Lancet medical journal about a new virus that had emerged in Wuhan, China, and spread rapidly among a family of six, but made no mention of the possibility that it might be the harbinger of a global pandemic.
Nevertheless, Şahin says he “immediately knew that this was different compared to previous outbreaks.” Just a few days later, he informed BioNTech’s board of his concerns, raising the alarm, and dedicated more than 40 employees to COVID-19 research and the pursuit of a vaccine for the disease.
“We were therefore able to start our vaccine research ahead of the curve. Now we have 400 employees working on this project,” he said in an email interview.
Originally born in Turkey, Şahin studied medicine at the University of Cologne in Germany before studying for a Ph.D. at the University of Homburg/Saar, continuing his academic career as a Junior Research Group Leader at the Johannes Gutenberg University in Mainz in 2001.
A specialist in immunology and oncology, he co-founded cancer antibody specialist Ganymed Pharma in 2001 – which was bought by Astellas for $1.4 billion in 2016—and co-founded BioNTech in 2008 “based on the fundamental belief that every cancer patient is unique and therefore their treatment should be individualized.”
Over the last 12 years, BioNTech has brought together a suite of technologies to achieve that vision, including a position in messenger RNA (mRNA)—the platform which underpins the company’s COVID-19 vaccine, BNT162b2, now a front-runner in the race to approval.
mRNA shots could in principle be quicker and cheaper than conventional vaccines to produce, helping to meet the massive demand for vaccinations against SARS-CoV-2 around the world.
According to latest figures from the World Health Organization, there are 42 potential COVID-19 vaccines in clinical development, and BioNTech is furthest ahead among four based on RNA, which instruct the body to produce copies of the spike protein found on the surface of the coronavirus to stimulate an immune response.
BioNTech and its development partner Pfizer started a rolling submission for BNT162b2 to the European Medicines Agency (EMA)—the second COVID-19 vaccine to start that process after AstraZeneca’s AZD1222—and reckon it could be ready for approval before the end of the year.
The vaccine’s rapid development has thrust all the leading COVID-19 vaccine developers, including BioNTech, under the twin headlights of public and political pressure to get a shot through development as quickly as possible, but—ever the scientist—Şahin says it is important to maintain calm and measured.
“We are focusing on our main goal: to develop a safe and effective vaccine,” he said. “We are aware of our responsibility that comes along with it, which was also the reasoning behind signing [a] historic pledge with eight other biopharmaceutical companies, promising to uphold the integrity of the scientific process.”
That pledge—with the CEOs of AZ, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi—came as political leaders including President Trump in the U.S. have been touting accelerated timelines for COVID-19 vaccine development, raising concerns that safety and efficacy standards may not be adhered to.
“Despite the urgency, the highest priority should always be the safety and efficacy of potential therapeutics and vaccines against SARS-CoV-2,” Şahin said.
Another key challenge will be the expansion of manufacturing capacities in a manner that allows production of potential vaccines or therapeutics for a global supply—particularly as he believes that that in order to eliminate the virus, more than 90% of the population will need to get immunity.
That is why BioNTech’s involvement with the COVAX initiative—established by Gavi, the Vaccine Alliance; the Coalition for Epidemic Preparedness Innovations (CEPI); and the World Health Organization (WHO)—is so important, Şahin said.
“We believe that collaboration and solidarity can help address a global health crisis as an international community. By agreeing to supply COVAX, biopharma companies can support the equitable access for all countries.”
Achieving that manufacturing scale was one of the drivers behind the partnership with Pfizer, one of the largest pharma companies in the world, but even that alliance isn’t enough to meet demand. The partners have just signed on German contract manufacturer Rentschler Biopharma to help with downstream purification as BNT162b2 enters the home stretch.
Last month, BioNTech also agreed to buy a Novartis biologics facility in Marburg, Germany, that is expected to be fully operational in the first half of 2021 and could have an annual capacity of up to 750 million doses of the shot when fully operational.
“Hopefully, we will be able to contribute to ending this pandemic with our vaccine. However, until then we will need to continue to live with the current safety measurements that are being taken,” Şahin said. “Another pandemic is possible in the future, so being able to act even more quickly than the world has this time around could be even more important in the future.”