EMA Committee Adopts Positive Opinion For Moderna COVID-19 Vaccine In Adolescents

The European Medicines Agency's or EMA Committee for Medicinal Products for Human Use or CHMP adopted a positive opinion recommending marketing authorization for Moderna Inc.'s (MRNA) COVID-19 vaccine, Spikevax, to include adolescents 12 years of age and older, the company said in a statement.

"The CHMP recommendation of the authorization of our COVID-19 vaccine for use in individuals 12 years of age and older in the European Union is a positive step forward toward authorization of our vaccine in this age group," said Stéphane Bancel, Chief Executive Officer of Moderna.

Moderna said it is also conducting a Phase 2/3 study, called the KidCOVE study, of mRNA-1273 in children ages 6 months to less than 12 years.

On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has received emergency or other conditional, interim or provisional authorization for use of its COVID-19 vaccine in adults from health agencies in more than 50 countries and an Emergency Use Listing from the World Health Organization (WHO).

Moderna has filed for emergency or other conditional, interim or provisional authorization for use of its COVID-19 vaccine in adolescents with global health agencies.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Nestle USA Inc., affiliated to Swiss food and beverage giant Nestle SA, is recalling around 27,872 pounds of frozen DiGiorno Crispy Pan Crust pepperoni pizza citing misbranding and undeclared soy protein, a known allergen, according to the U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS. Eli Lilly and Co. is recalling one lot of GLUCAGON Emergency Kit for low blood sugar to the consumer/user level citing loss of potency, the U.S. Food and Drug Administration announced. The recall involves lot D239382D with expiration date of April 2022 of Glucagon Emergency Kit containing 1mg of freeze-dried (lyophilized) product in a 3 mL vial and a pre-filled diluent syringe. Twitter has rolled out the tipping feature called "Tips" for everyone around the globe using the microblogging site with more payment options to choose from, including cryptocurrencies such as Bitcoin. This is a new way for people to receive and show support on Twitter with money. The feature is currently available on iOS and will be available on Android over the coming weeks.
Follow RTT