Posted by Michael Wonder on 11 Sep 2021
MHRA statement on booster doses of Pfizer and AstraZeneca COVID-19 vaccines
9 September 2021 - The regulatory changes made by the MHRA today give further options for the deployment programme.
The current supply of the COVID-19 vaccines made by Pfizer and AstraZeneca has been authorised on an emergency use basis by the MHRA under Regulation 174 of the Human Medicine Regulations 2012 and the changes today have been made to the Regulation 174 Product Information only.
Both vaccines are also authorised under Conditional Marketing Authorisations (CMAs) but changes to these would follow a different procedure. Vaccines covered by CMAs can also be used as part of a deployment programme via “off-label” use under a prescriber’s direction.
