BioNTech CEO Believes COVID-19 Vaccine Could be Ready for Approval by December

BioNTech Chief Executive Officer Ugur Sahin predicts the company’s vaccine for COVID-19, which is it co-developing with Pfizer, could be ready for regulatory approval by the end of the year, with hundreds of millions of doses available for immediate distribution.

In an interview with The Wall Street Journal, Sahin talked about the progress the companies have made on their vaccine candidate and said their manufacturing capabilities could provide about one billion doses of the preventative drug by the end of 2021. The vaccine candidate is expected to initiate Phase III studies by the end of this month with about 30,000 patients. If all goes well, Sahin said Germany-based BioNTech and Pfizer could seek regulatory approval from global health authorities by the end of the year. If the vaccine is approved, Sahin said mass vaccinations could begin in the United States, Europe and elsewhere.

Sahin’s comments to the Journal came about a week after the two companies released preliminary data from the most advanced of four of its vaccine candidates against SARS-CoV-2, the virus causing COVID-19. The data from research on BNT1621b1, which encodes an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen, was positive. As BioSpace reported earlier this month, neutralizing antibodies were observed at 1.8- to 2.7-times the level of those found in patients who recovered from COVID-19. While it’s currently unknown if those higher levels will provide an immunity against the virus, the study beginning this month will attempt to prove that people who are dosed with the vaccine are at least 50% less likely to become infected. The data has been submitted to a journal for publication but has yet to be peer-reviewed.

The messenger-RNA vaccine candidate is similar to the program under development by Massachusetts-based Moderna, Inc. The premise of the vaccine is to use messenger RNA that codes for a specific molecule on the surface of the SARS-CoV-2. The vaccine is designed to create that specific molecule in hopes that the body’s immune system will be able to identify and neutralize the virus before it can replicate. Pfizer and BioNTech initiated their collaboration in March.

Moderna is expected to begin Phase III studies of its vaccine candidate this month as well. The company was initially expected to begin its late-stage study this week, but that was delayed due to squabbles with U.S. scientists over trial protocols and directives on how to run the study, Reuters reported this week. Part of that appears to be due to the fact that government scientists expressed concern that Moderna has not run a trial of this size before and lacks the staff and expertise to do so, according to the report. Still, the trial is expected to begin before the end of the month with data expected after Thanksgiving.

Progress on the development of the Pfizer/ BioNTech vaccine, as well as vaccine candidates under development by other companies, has been rapid to say the least. Necessity has pushed the companies to an unprecedented acceleration of their programs in a matter of months, as opposed to the decade a vaccine typically takes to develop.

In his interview with the Journal, Sahin speculated that billions of vaccines will have to be delivered across the globe before there is sufficient immunity against COVID-19. The novel coronavirus has infected nearly 13 million people across the world, including more than 3 million in the United States. Even with vaccines, Sahin said it will likely take 10 years before herd immunity is achieved against COVID-19.

“I assume that we will only be done with this virus when more than 90% of the global population will get immunity, either through infection or through a vaccine,” Sahin told the Journal.