- Pfizer and BioNTech on Tuesday said the first healthy volunteers have received the companies' coronavirus vaccine in a U.S. trial, following the completion of dosing in a Germany-based study last week.
- The U.S. trial will expand to four sites, first testing the vaccine in adults under age 55 and extending to those 65 to 85 once data from the younger enrollees show it's safe and stimulates an immune response to coronavirus. Four different prototypes of the vaccine will be tested in the trial, which will enroll 360 people.
- Pfizer and BioNTech expect to have initial data from the trial in late May or June. Pfizer is also preparing to scale up manufacturing to deliver millions of doses by the end of 2020.
The race to deliver a vaccine that will prevent further spread of the novel coronavirus is intensifying, with at least seven already being tested in humans.
BioNTech and its rival Moderna are pursuing mRNA vaccines — treatments containing genetic instructions for cells to make immune-stimulating proteins — and have been among the first out of the gate due in part to the speed at which such vaccines can be designed.
Initial data assessing their safety and the type of immune response they whip up should be available within weeks. Moderna's mRNA-1273 has completed enrollment in a Phase 1 trial sponsored by the National Institute of Allergy and Infectious Diseases, and the company has asked the Food and Drug Administration for permission to proceed into Phase 2.
No mRNA vaccine has ever received regulatory approval, however, and thus older technologies like virus-based and protein-based approaches have also drawn attention. One of the earliest vaccines in testing was from CanSino Biologics, which has already entered Phase 2 with an approach that relies on harmless viruses engineered to stimulate a response to SARS-CoV-2 infections.
Even though these vaccine candidates have yet to prove they are safe and prevent COVID-19, manufacturers are risking tens, and even hundreds, of millions of dollars building their manufacturing capacity to meet expected demand.
In Pfizer's first quarter earnings call, CEO Albert Bourla said the company is on schedule to have the capacity to produce millions of doses of BioNTech's candidate by the end of 2020 and potentially hundreds of millions by the end of 2021.
Moderna, meanwhile, has reached agreement with Lonza to produce potentially 1 billion doses per year. Johnson & Johnson partnered with Catalent to build 24-hour-a-day, seven-day-a-week production capacity, in the hopes that its candidate, which uses a similar approach as CanSino, will successfully prevent coronavirus infections.
Pfizer signed BioNTech to a coronavirus vaccine deal with $185 million in upfront cash, including a $113 million stock purchase, and a promise of up to $563 million in future milestone payments.