Nuvaxovid, the COVID-19 vaccine developed by Novavax, has today been granted an extension to its existing UK approval, for 12- to 17-year-olds. This extension has been authorized by the Medicines and Healthcare products Regulatory Agency (MHRA).
The approval follows a review of the safety, quality and effectiveness of the vaccine in this age group, and expert advice from the government's independent scientific advisory body, the Commission on Human Medicines.
Dr June Raine, MHRA Chief Executive, said:
Following our review of the safety, quality and effectiveness of Nuvaxovid in 12- to 17-year-olds, I am pleased to confirm that that the vaccine has now been authorized in this age group. In reaching this decision, we have taken advice from the government's independent scientific advisory body, the Commission on Human Medicines."
The Conditional Marketing Authorisation (CMA) extension granted by the MHRA is valid in Great Britain only and was approved via the European Commission (EC) Decision Reliance Route. This is when the marketing authorisation application made by the company references the decision made by the EMA's Committee for Medicinal Products for Human Use (CHMP).
Nuvaxovid is authorised in children aged 12-17 years in Northern Ireland under the CMA extension granted by the European Medicines Agency on 1 July 2022.
Limited impact of prenatal COVID-19 exposure on child neurodevelopmental outcomes