Novavax COVID-19 vaccine granted UK approval for 12- to 17-year-olds by MHRA

Nuvaxovid, the COVID-19 vaccine developed by Novavax, has right this moment been granted an extension to its current UK approval, for 12- to 17-year-olds. This extension has been approved by the Medicines and Healthcare merchandise Regulatory Company (MHRA).

The approval follows a overview of the security, high quality and effectiveness of the vaccine on this age group, and knowledgeable recommendation from the federal government’s unbiased scientific advisory physique, the Fee on Human Medicines.

Dr June Raine, MHRA Chief Govt, stated:

Following our overview of the security, high quality and effectiveness of Nuvaxovid in 12- to 17-year-olds, I’m happy to substantiate that that the vaccine has now been approved on this age group. In reaching this choice, we’ve taken recommendation from the federal government’s unbiased scientific advisory physique, the Fee on Human Medicines.”

The Conditional Advertising and marketing Authorisation (CMA) extension granted by the MHRA is legitimate in Nice Britain solely and was accredited through the European Fee (EC) Choice Reliance Route. That is when the advertising and marketing authorisation software made by the corporate references the choice made by the EMA’s Committee for Medicinal Merchandise for Human Use (CHMP).

Nuvaxovid is authorised in kids aged 12-17 years in Northern Eire beneath the CMA extension granted by the European Medicines Company on 1 July 2022.