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Two experimental coronavirus vaccines jointly developed by German biotech firm BioNTech and US pharmaceutical giant Pfizer received the “fast-track” designation by the US regulatory agency, the companies announced.
The candidates, BNT162b1 and BNT162b2, are the most advanced of at least four vaccines evaluated by companies in trials in the United States and Germany.
Earlier in the month, the firms said that BNT162b1 showed potential against the virus and was found to be well tolerated in the early stages of their trials.
Initial data from the German BNT162b1 trial is expected to be released in July, the companies said.
If the ongoing studies are successful and the vaccine candidate Receiving regulatory approval, the companies said they expect to be able to make up to 100 million doses by the end of the year and potentially more than 1.2 billion by the end of 2021.
The companies said they hope to start a large trial with up to 30,000 participants by the end of the month at the earliest, if they receive regulatory approval.
The “fast track” status of the Food and Drug Administration (FDAguarantees an acceleration of the review of new drugs that show potential to deal with unpublished medical needs.
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