BioNTech and partner Pfizer are celebrating reaching the one billion dose milestone for their COVID-19 vaccine as demand for the innovative mRNA jab remains strong.
“We are proud to have reached this great milestone after only six months,” said Ugur Sahin, CEO and co-founder of BioNTech. “To address the ongoing pandemic, we are expanding the supply of our COVID-19 vaccine to more than 100 countries and regions worldwide, including enhancing access to low- and middle-income countries.”
The Mainz-based company’s fortunes continue to rise. Revenues for the three months to June 2021 were €5.3bn, compared to €41.7m for the same period in 2020, while it has already signed deals to supply 2.2 billion doses of its BNT162b2 vaccine in 2021. It expects global manufacturing capacity to reach 3 billion doses by the end of the year.
The company now estimates its 2021 revenues to be €15.9bn, exceeding earlier forecasts. Its shares have increased more than four-fold in the past year.
Speaking to investors, newly appointed chief financial officer Jens Holstein said BioNTech would spend a billion euros on R&D “to expand and accelerate our pipeline development” as part of a “ramp up” in the second half of the year.
The strategy is to move beyond COVID-19 to develop “a broad pipeline of next-generation immunotherapies and vaccines” that address unmet medical need in cancer, infectious disease as well in a growing list of other diseases, added CEO Sahin.
The company’s oncology pipeline has 15 product candidates in 18 ongoing trials, including two phase 2 trials for its anticancer candidate FixVac in melanoma and head and neck squamous cell carcinoma. “We were able to advance multiple oncology programmes across various technology platforms which are now entering later stage testing, providing the potential for introducing a series of product candidates to the market in the coming years,” said Sahin.
However, its COVID-19 vaccine remains a key clinical development priority, and multiple clinical trials are underway covering “new regions and population groups”, including studies in children under 12 and pregnant women.
BioNTech is also running trials for booster shots and to test the efficacy of variants, with a trial underway for the beta variant and another launching to look at the delta variant.
The company is in ongoing discussions with regulatory agencies around a booster shot. “We have the ability to rapidly change the strain for manufacturing,” said Sahin, however, BioNTech believes that the best approach is a third dose of its original vaccine 6-12 months after the second dose.
He compared the situation to influenza where the WHO defines which strains of the disease will be targeted. “We do not yet have such a situation for the coronavirus,” he said. “And the challenge at the moment, the global challenge is that there are different variants on different continents. Even though the Delta variant is dominating North region, there are other regions like South Africa,” where the Beta variant is more prevalent.