Second Pfizer/BioNTech bivalent COVID-19 booster vaccine approved by UK medicines regulator
This adapted COVID-19 vaccine targets both the original virus and the Omicron BA.4 and BA.5 sub-variants.
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.
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.
Notes to editors:
- The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. The CHM is an advisory non-departmental public body, sponsored by the Department of Health and Social Care.
- This new line extension granted by the MHRA is valid in Great Britain only and was approved via the European Commission (EC) Decision Reliance Route. This is when the marketing authorisation application made by the company references the decision made by the EMA’s Committee for Medicinal Products for Human Use (CHMP). In such cases, the MHRA considers the application together with due consideration of the EC decision, before making an independent decision on the quality, safety and effectiveness of the vaccine.
- More information can be found in the product information for the Pfizer/BioNTech bivalent vaccine.
- A recent paper in The Lancet journal suggested that COVID-19 vaccines have prevented up to 20 million deaths in the first year of use.
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