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The federal government granted a fast-track designation to two potential coronavirus vaccines opening up the possibility for large-scale testing this month, according to the drugs’ manufacturers.
American pharmaceutical giant Pfizer and European partner BioNTech announced the designation in a press release Monday. A fast track designation is a process designed to expedite the development of important drugs, according to the U.S. Food and Drug Administration.
“The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” said Peter Honig, Pfizer senior vice president of global regulatory affairs.
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The companies expect large-scale phase 3 trials with up to 30,000 volunteers to begin by the end of July, according to the press release. Phase 3 trials are one of the final speed bumps before a drug is approved.
The companies also expect to manufacture as many as 100 million doses of the drugs by the end of the year and 1.2 billion doses by 2022, the press release said. These vaccines aren’t the only drugs in trial that are being produced before approval, according to National Institutes of Health director Dr. Francis Collins.Read the rest of the story HERE and follow links below to related stories and resources:
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