Medicines Healthcare Products Regulatory Agency
This vaccine triggers the production of antibodies and blood cells by the immune system to work against COVID-19.
Two presentations of this adapted Comirnaty KP.2 COVID-19 vaccine have been approved by the MHRA under the International Recognition Procedure after they were found to meet the UK regulators standards of safety, quality, and effectiveness.
As with all products, the MHRA will keep the safety of this vaccine under close review.
A full list of all side effects reported with this medicine is available in the patient information leaflet (PIL), which can be obtained from the pharmacy, or from the product information published on the MHRA website.
If a patient experiences any side effects, they should talk to their doctor, pharmacist or nurse. This includes any possible side effects not listed in the product information or the PIL which comes with this medicine.
Patients can also report suspected side effects themselves, or a report can be made on their behalf by someone else, directly via the Yellow Card scheme. By reporting side effects, patients can help provide more information on the safety of this vaccine.
Notes to editor
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The authorisation was granted as part of the International Recognition Procedure (IRP), via the reference regulator, the European Medicines Agency (EMA). Launched in January this year, the IRP allows the MHRA to accelerate the assessment of new medicines by considering the expertise and decision-making of trusted regulatory partners in the authorisation process.
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The Comirnaty KP.2 COVID-19 vaccine products are line extensions of the existing product, Comirnaty 30 micrograms/dose dispersion for injection. The two approved products are:
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Comirnaty KP.2 30 micrograms/dose dispersion for injection in multidose vials for use in adults
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Comirnaty KP.2 30 micrograms/dose dispersion for injection in pre-filled syringe for use in adults
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The MHRA is an executive agency of the Department of Health and Social Care.
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.? All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020