MHRA approve Pfizer and AstraZeneca COVID-19 vaccine booster doses
Posted: 10 September 2021 | Anna Begley (European Pharmaceutical Review) | No comments yet
The UK regulator confirmed that the Pfizer and AstraZeneca COVID-19 vaccines can be used as safe and effective booster doses.
Following a review by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the independent Commission on Human Medicines (CHM), the MHRA have confirmed that booster doses for Pfizer and AstraZeneca COVID-19 vaccines are safe and effective. The regulatory changes provide further options for a deployment programme for a third dose.
“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,” commented Dr June Raine, MHRA Chief Executive. “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.
“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 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 Joint Committee on Vaccination and Immunisation (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,” added Raine.
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AstraZeneca, Medicines and Healthcare Products Regulatory Agency (MHRA), Pfizer