The UK Medicines and Healthcare Products Regulatory Agency (MHRA), has approved Nuvaxovid, COVID-19 vaccine developed by Novavax, as a vaccine booster for 12 years to 17 years old children. The approval follows a review of the safety, effectiveness, and quality of the COVID-19 vaccine in the age group, and expert advice from the Commission on Human Medicines, an independent scientific advisory body of the UK government.
Dr. June Raine, chief executive of the UK MHRA, said that following their review of the safety, effectiveness, and quality of Nuvaxovid in 12-to-17-year children, he is pleased to confirm that the COVID-19 vaccine has now been authorised in the age group.
To reach this decision, they have taken advice from the Commission on Human Medicines of the UK government. The approval from UK MHRA is valid in Great Britain only and was also approved through the European Commission (EC) Decision Reliance Route.
Nuvaxovid is also approved for children aged 12 years to 17 years in the region of Northern Ireland under the CMA extension granted by the European Medicines Agency on July 1 2022. This approval came when the marketing authorization application made by the company referenced the decision made by the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA).