- Healthy volunteers in Germany will soon receive one of several versions of an experimental coronavirus vaccine developed by BioNTech and partner Pfizer, after regulators in the country cleared a clinical study to begin.
- The trial, which will enroll some 200 adults, is the first study of a coronavirus vaccine to begin in Germany, and one of only six ongoing worldwide. BioNTech and Pfizer said they expect to soon receive an OK from the Food and Drug Administration to start human tests of their vaccine prototypes in the U.S.
- Pfizer and BioNTech have moved quickly to begin testing the German biotech's vaccine technology in humans. Like Moderna, which was first into the clinic with a potential coronavirus vaccine, BioNTech uses messenger RNA to spur the body's cells to make a non-infectious part of the coronavirus, training the immune system to respond to the real virus.
The speed at which drugmakers are moving to design and develop treatments for the coronavirus is well known. But regulators are moving just as quickly.
The Paul Ehrlich Institute, which in Germany is responsible for authorizing clinical trials, took just four days to approve human testing of BioNTech's vaccine. Regulators in the U.S. and China have also acted rapidly to allow studies of other vaccines to move forward.
Pfizer and BioNTech began working together last month, and only finalized partnership terms on April 9. The pharma is paying the German biotech $72 million in cash and investing another $113 million in the company — a sizable sum for an early-stage collaboration. The companies will split the costs of developing a coronavirus vaccine.
The study in Germany is one of the first steps in that process. Four variations of BioNTech's vaccine platform will be tested, all of which are designed to elicit production of a protein used by the SARS-CoV-2 virus to enter human cells.
Two versions encode for the larger "spike" protein, while the other two contain code for the part of the spike that's thought to be most critical for triggering antibodies capable of recognizing and fighting off SARS-CoV-2.
The Phase 1/2 study will attempt to find an optimal vaccine dose, as well as provide initial information on the vaccine's safety and the type of immune response it produces. For three of the four versions, Pfizer and BioNTech will also study the effects of repeat, or "prime" and "boost," immunization.
During clinical development, BioNTech will manufacture the experimental vaccines, but Pfizer is working to scale up production capacity now should testing prove the treatment safe and effective.
If all goes to plan, the companies said they could supply millions of vaccines doses by the end of 2020 and hundreds of millions of doses by next year.
Pfizer and BioNTech are also planning to conduct studies in the U.S. and said a go-ahead from the Food and Drug Administration is "expected shortly."
Moderna and Inovio Pharmaceuticals have already begun Phase 1 trials of their respective coronavirus vaccines in the U.S., while, in China, CanSino Biologics, SinoVac Biotech and the Wuhan Institute of Biological Products have launched human studies as well.