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The US Food and Drug Administration has granted “fast track” status to Novavax’s experimental coronavirus vaccine, the company announced Monday. The designation will allow the
The US Food and Drug Administration has granted “fast track” status to Novavax’s experimental coronavirus vaccine, the company announced Monday.
The designation will allow the Maryland-based biotech firm to submit its application for regulatory approval piecemeal as data becomes available — rather than waiting to compile all the results before submitting the application.
The decision “reflects the urgent need for a safe and effective vaccine to prevent COVID-19, and we look forward to working closely with the agency to accelerate access to this vaccine,” Dr. Gregory M. Glenn, Novavax’s president of research and development, said in a statement.
“While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the US and globally,” Glenn added.
Novavax said it plans to start a so-called Phase 3 clinical trial for its vaccine in the US and Mexico by the end of this month. That would make it the fifth drug maker to begin a crucial late-stage study in America aimed at proving whether the inoculation is safe and effective.
The company said data from the trial could support approval for the vaccine in the US, where the Trump administration has committed $1.6 billion to help Novavax develop and produce the shot. Novavax also expects to have interim data from a Phase 3 study it’s running in the UK by early next year.
Novavax announced its fast-track designation hours after Pfizer and BioNTech revealed their vaccine was more than 90 percent effective in a Phase 3 trial involving more than 43,000 participants. Such studies are also underway in the US for potential vaccines from Moderna, AstraZeneca and Johnson & Johnson.