MHRA has approved Moderna’s COVID-19 vaccine for use in 12–17-year-olds.
The United Kingdom’s medicine regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) has approved Moderna’s COVID-19 vaccine for use in 12–17-year-olds. The decision was announced in an Aug. 17, 2021 press release.
Confirming the vaccine (Spikevax) is safe and effective in adolescents, the conditional marketing authorization extension granted by the MHRA is valid for Great Britain. The approval was made via the European Commission Decision Reliance Route, which is when a marketing authorization application references the decision made by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
“I am pleased to confirm that that the COVID-19 vaccine made by Moderna has now been authorized in 12–17 year olds. The vaccine is safe and effective in this age group,” said June Raine, MHRA chief executive, in the press release. “We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines and this surveillance will include the 12- to 17-year age group. It is for the Joint Committee on Vaccination and Immunisation (JCVI) to advise on whether this age group should be vaccinated with the COVID-19 vaccine made by Moderna as part of the deployment program.”
Source: MHRA
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.