The company is developing vaccines under the BNT162 program under a partnership with Pfizer. However, Pfizer has declined to accept government funding, and BioNTech said the New York-based drugmaker will continue to cover its own expenses.
Financial terms of the deal were not disclosed, but it follows a $1.95 billion contract between the two companies and the U.S. government. Assuming clinical trial success and regulatory approval, they would supply the vaccines in early 2021, ahead of the rescheduled Tokyo Olympics.
Across the nation, state-based health insurance exchanges are searching for ways to better serve their communities while making enrollment easier, more personal, and more accessible for everyone.
The companies will supply 100 million doses of the vaccine by the end of the year, and the government will have the option to acquire 500 million more. However, the FDA must grant an authorization based on its safety and efficacy, for which there are only preliminary data so far.
The companies anticipate releasing more clinical data from the BNT162 messenger RNA vaccine program and potentially starting a 30,000-participant Phase IIb/III study this month.
The Phase I/II study dosed its first cohort in Germany last week. The trial is enrolling 7,600 participants who will be randomized to receive one of four vaccine candidates or placebo.