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Pfizer, BioNTech’s coronavirus vaccine gets the FDA’s “fast track” status

The head office of the German immunotherapy company BioNTech is located on April 22, 2020 in Mainz, Germany.

Thomas Lohnes | Getty Images

Two experimental coronavirus vaccines jointly developed by German biotech company BioNTech and US pharmaceutical giant Pfizer have received a “fast track”

; designation from the US drug regulator, the companies said on Monday.

The candidates, BNT162b1 and BNT162b2, are the most advanced of at least four vaccines assessed by the companies in ongoing studies in the United States and Germany.

Pfizer’s shares increased by about 2% and US-listed shares in BioNTech rose about 6% before the clock.

Earlier this month, companies said that BNT162b1 showed potential for the virus and was well tolerated in early human trials.

Early data from the German trial against BNT162b1 is expected to be released in July, the companies said.

If the ongoing studies are successful and the vaccine candidate gets regulatory approval, the companies said they expect to make up to 100 million doses by the end of this year and potentially more than 1.2 billion doses by the end of 2021.

The companies said they expect to start a major trial with up to 30,000 participants as soon as later this month, if they receive regulatory approval.

The Food and Drug Administration’s fast track is granted to expedite the review of new drugs and vaccines that show the potential to meet unsatisfied medical needs.

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