MHRA (UK) approves update for approval of the Moderna COVID 19 Vaccine (Spikevax) for 6 to 11 year olds.- Moderna
This approval takes into account the extension to use in children aged 6 to 11 years already approved by the European Medicines Agency on 2 March 2022, as the original GB licence for Spikevax in adults was approved by relying on the EU decision. Spikevax is authorised in children aged 6 to 11 in Northern Ireland under the update granted by the European Medicines Agency on 2 March.
Related news and insights
Palisade Bio, Inc. announced the first patient has been dosed in its Phase III study evaluating LB 1148 to accelerate the return of bowel function in adult patients undergoing gastrointestinal surgery.
bluebird bio, Inc. announced the FDA has approved Zynteglo (betibeglogene autotemcel), also known as beti-cel, a one-time gene therapy custom-designed to treat the underlying genetic cause of beta-thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions.
Edwards Lifesciences Corporation announced the company's PASCAL Precision transcatheter valve repair system received CE Mark for the treatment of mitral and tricuspid regurgitation (MR and TR).