4:44 PM 9th September 2021
MHRA Statement On Booster Doses Of Pfizer And AstraZeneca COVID-19 Vaccines
The regulatory changes made by the MHRA today give further options for the deployment programme.
Dr June Raine, MHRA Chief Executive said:
"We are committed to getting safe and effective COVID-19 vaccines to the UK public. This means ensuring that existing COVID-19 vaccines can continue to be used in the most effective way possible.
"We know that a person’s immunity may decline over time after their first vaccine course. I am pleased to confirm that the COVID-19 vaccines made by Pfizer and AstraZeneca can be used as safe and effective booster doses. This is an important regulatory change as it gives further options for the vaccination programme, which has saved thousands of lives so far. It will now be for the JVCI to advise on whether booster jabs will be given and if so, which vaccines should be used.
"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 booster jabs."
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.
This regulatory decision follows a careful review of available data on safety and effectiveness of booster or supplementary vaccine doses by the MHRA and the independent Commission on Human Medicines (CHM), which advises the government.