Moderna said that it has been informed that the U.S. Food and Drug Administration will need more time to complete its review of the companys COVID-19 vaccine for use in children between 12 and 17 years of age.

The FDA has informed Moderna that the review may not be completed before January next year. Moderna Chief Executive Stephane Bancel had said last week that based on conversations with the FDA, the vaccine would be authorized for 12- to 17-year-olds in the next few weeks. However, the company said that it was told late on Friday that the agency required additional time to assess the latest international analyses of the risk of myocarditis following vaccination… (Reuters, November 1, 2021)