MHRA approves second Covid-19 booster vaccine

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a second “bivalent” vaccine as a Covid-19 booster.

The updated booster vaccine made by Pfizer/BioNTech, targeting two coronavirus variants, has been approved for use in individuals aged 12 years and above.

In each dose of the booster vaccine, ‘Comirnaty bivalent Original/Omicron’, half of the vaccine (15 micrograms) targets the original virus strain and the other half (15 micrograms) targets Omicron (BA.1).

Dr June Raine, MHRA chief executive said: “I am pleased to announce that we now have a second approved vaccine for the UK Autumn booster programme. The clinical trial of the Pfizer/BioNTech bivalent vaccine showed a strong immune response against the Omicron BA.1 variant as well as the original strain.

Bivalent vaccines are helping us to meet the challenge of an ever-evolving virus, to help protect people against Covid-19 variants. We have in place a comprehensive safety surveillance strategy for all UK-approved Covid-19 vaccines, and this will include the updated booster we approved today.”

Following an independent review of the safety, quality and effectiveness of the vaccine, the Commission on Human Medicines and its Covid-19 Vaccines Expert Working Group supports the MHRA’s decision.

The Joint Committee on Vaccination and Immunisation (JCVI) will advise on how this vaccine should be offered as part of the deployment programme.

Studies indicate the Pfizer-BioNTech bivalent vaccine produces a marginally higher immune response against some variants than the Pfizer-BioNTech mRNA Original ‘wild-type’ vaccine. The clinical relevance of these small differences is uncertain.

Professor Wei Shen Lim, chair of Covid-19 immunisation on the JCVI, said: "It is very encouraging that more vaccines continue to become available and we now have another option to add to the vaccines already advised for the autumn booster campaign.

Winter is typically the time of greatest threat from respiratory infections. We strongly encourage everyone who is eligible to have their booster vaccine this autumn when it is offered. This is our best defence against becoming severely ill from Covid-19."