Pharmaceutical company Moderna intends to apply Monday to the US Food and Drug Administration (FDA) for authorization of its Covid-19 vaccine.
The company will ask the FDA to review an expanded data set showing the vaccine is 94.1% effective at preventing Covid-19 and 100% effective at preventing severe cases of the disease.
This is striking,” said Dr. Paul Offit, a member of the FDA’s vaccine advisory committee. “These are amazing data.”
One other company, Pfizer, has already applied for FDA authorization for a coronavirus vaccine, with efficacy data very similar to Moderna’s results. The FDA is expected to review both companies’ applications in December, and Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, said he expects the first vaccinations in the US to occur “towards the latter part of December.”
By the end of 2020, Moderna expects to have approximately 20 million doses of its vaccine available in the United States, and it’s on track to manufacture 500 million to 1 billion doses globally next year, according to the company’s news release Monday.