MHRA grants approval for second Pfizer/Biontech bivalent Covid-19 booster vaccine

Approval has today been granted by the Medicines and Healthcare products Regulatory Agency (MHRA) for a Pfizer/BioNTech 'bivalent' Covid vaccine that targets both the Original strain of SARS-CoV-2 and the Omicron BA.4 and BA.5 sub-variants. The updated booster vaccine is the second bivalent vaccine from Pfizer/BioNTech to receive MHRA approval, after it was found to meet the UK regulator's standards of safety, quality and effectiveness.

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The vaccine has been approved for use as a booster dose in individuals aged 12 years and above. This decision has been endorsed by the Commission on Human Medicines, after a careful review of the evidence.

In each dose of the booster vaccine, half of the vaccine (15 micrograms) targets the original virus strain and the other half (15 micrograms) targets Omicron (BA.4-5).

The MHRA's decision is based on all available evidence on the original Pfizer/BioNTech COVID-19 vaccine and its adapted vaccines. This includes extensive safety and effectiveness data for the original vaccine, clinical data from the bivalent original/omicron BA.1 vaccine and safety data from an on-going clinical trial. These show that the common side effects observed with the new bivalent vaccine were the same as those seen for other versions of the vaccine. These side-effects were typically mild and self-resolving, with no new safety concerns identified.

All approved covid booster vaccines help to improve the protection obtained from earlier doses of the vaccine and help give longer-term protection against getting seriously ill from COVID-19. For the UK Autumn booster campaign, the MHRA advises people to come forward for their booster vaccination when invited to do so.