Moderna Seeks FDA Approval for Emergency Use of COVID-19 Caccine

Moderna is to seek FDA authorisation and of the European regulators for emergency use of its vaccine. If authorization is granted, the first shots in US could be given as early as December 21.

Multiple vaccine candidates must succeed for the world to stamp out the pandemic, which has been on the upswing in the US and Europe. US hospitals have been stretched to the limit as the nation has seen more than 160,000 new cases per day and more than 1,400 daily deaths.

Moderna’s application is based on data 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 company is “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 just behind Pfizer and its German partner BioNTech in seeking to begin vaccinations in the US in December. Across the Atlantic, British regulators also are assessing the Pfizer shot and another from AstraZeneca.