Moderna to seek FDA approval for vaccine use – Times of India

The drugmaker Moderna said it would apply Monday to the FDA to authorise its coronavirus vaccine for emergency use. The first injections may be given as early as December 21 if the process goes smoothly and approval is granted, said Stephane Bancel, the firm’s chief executive.
Moderna’s application is based on data that it also announced on Monday showing that its vaccine is 94.1% effective, and that its study of 30,000 people has met the scientific criteria needed to determine whether the vaccine works. The new data also showed that the vaccine was 100% effective at preventing severe disease from the coronavirus.
Bancel said the company was “on track” to produce 20 million doses by the end of December, and 500 million to a billion in 2021. Each person requires two doses, administered a month apart, so 20 million doses will be enough for 10 million people. Moderna is the second vaccine-maker to apply for emergency use authorisation. Pfizer submitted its application November 20. Independent advisers to the FDA are scheduled to meet on December 10 to review Pfizer’s data and make a recommendation to the US regulator. They will review Moderna’s data a week later on December 17.
The first shots of the two vaccines are likely to go to certain groups, including health workers. On Tuesday, a panel of advisers to the Centers for Disease Control will meet to determine how to allocate initial supplies of vaccine.

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