Fast track is a process designed to speed up the development and review of drugs to treat serious conditions. According to the FDA, "the purpose is to get important new drugs to the patient earlier."
The two vaccine candidates were the "most advanced" out of four investigational vaccine candidates and were currently tested in clinical studies in the U.S. and Germany, the companies announced in a joint statement.
"We look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward," said Oezlem Tuereci, chief medical officer at BioNTech.
At the beginning of July, BioNtech and Pfizer presented initial results for a COVID-19 vaccine. The companies noted that the results were "encouraging."
The FDA's decision would "signify an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2," said Peter Honig, senior vice president, global regulatory affairs, Pfizer.
Subject to regulatory approval, the two companies are expecting to start the next phases of the trial with up to 30,000 participants later this month.
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