The Medicines and Healthcare products Regulatory Agency has confirmed that approved vaccines meet strict regulatory standards for safety.
Routine safety monitoring and analysis of the approved coronavirus vaccines shows that the safety of these vaccines remains as high as expected from the clinical trial data that supported the approvals. The safety profile of the vaccines remains positive and the benefits continue to far outweigh any known side-effects.
Over 10 million doses of the Pfizer/BioNTech and the Oxford University/AstraZeneca vaccines have been given across the UK and the MHRA has gathered a large amount of safety data.
The MHRA has signalled there have been 22,820 reports of suspected side effects, or an overall reporting rate of three in 1,000 doses of vaccine administered from 9 December 2020 to 24 January 2021. The vast majority of reported side effects are mild and all are in line with most types of vaccine, including the seasonal flu vaccine.
The MHRA has also published the first of what will be regular Covid-19 vaccine safety reports. These provide details on the suspected side-effects to the vaccines reported through its safety monitoring system, the Yellow Card scheme. This data has been thoroughly analysed by the MHRA’s scientists and safety experts together with all other sources of evidence.
Dr June Raine, MHRA chief executive, said: “Vaccines are the most effective way to protect against Covid-19 and save lives and prevent serious complications from this terrible virus. The data we have collected provides further reassurance that the Covid-19 vaccines are safe and continue to meet the rigorous regulatory standards required for all vaccines. We remain confident that the benefits of these vaccines outweigh any risks.
“Our priority is to ensure the public have safe and effective vaccines and we will continue to analyse, monitor and review all the safety data for these vaccines. I’d like to thank everyone who has reported a potential side effect to us - every report matters.”