- Two experimental coronavirus vaccines developed by Pfizer and BioNTech received Fast Track status from the US Food and Drug Administration, the companies announced Monday.
- Pfizer shares gained nearly 3% in premarket trading Monday.
- BioNTech’s US shares surged as much as 11% in premarket trading Monday.
- Watch Pfizer and BioNTech trade live on Markets Insider.
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The candidates that received Fast Track status, BNT162b1 and BNT162b2, are the most advanced of four potential vaccines being developed by the German biotech company and the US pharmaceutical giant.
Both are being assessed in ongoing trials in the US and Germany. In early July, BNT162b1 showed positive early results in a human trial in the US. Early data from the German trial of BNT162b1 are expected to be released in July, the company said.
Pfizer and BioNTech expect to start another large trial with up to 30,000 participants later this month, subject to regulatory approval.
If the ongoing studies are successful, and the vaccine candidate receives regulatory approval, the companies said they expect to manufacture up to 100 million doses by the end of the year and potentially more than 1.2 billion doses by the end of 2021.
The FDA’s Fast Track process is designed to speed the development and review of drugs and vaccines that “are intended to treat or prevent serious conditions that have the potential to address an unmet medical need,” according to a statement.
Pfizer has shed nearly 14% year-to-date, while BioNTech shares have skyrocketed 107%.
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