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Two potential coronavirus vaccines received Fast Track designation from the Food and Drug Administration on Monday.
Pfizer and BioNTech said in a press release that “the designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the United States and Germany, as well as animal immunogenicity studies.”
The designation applies to two of the companies’ four vaccine candidates: BNT162b1 and BNT162b2. The vaccines “are the two most advanced vaccine candidates” currently being evaluated by the companies, the release stated.
The fast track process is designed to expedite the development and review of new drugs and vaccines that “are intended to treat or prevent serious conditions that have the potential to address an unmet medical need,” according to the press release.
Cartoons on the Coronavirus
The designation, which companies must request, allows for a more efficient process between companies and regulatory agencies, making drug developers eligible for accelerated approval.
Pfizer and BioNTech expect to begin phase 2b/3 of their trials later this month. BioNTech said in the release that if the ongoing studies are successful, the companies expect to manufacture up to 100 million doses of the vaccine by the end of the year and 1.2 billion doses by the end of 2021.
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