Freedom of Information for each of the approved COVID-19 vaccines. the evidence of continual monitoring carried out, and any investigations and reviews of the associated data and calculations and associated data of the positive benefit/risk (FOI 22/019 )
Published 31 May 2022
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FOI 22/019
27th January 2022
Dear,
Thank you for your Freedom of Information (FOI) request dated 30 December 2021 regarding the COVID-19 vaccines. Under the FOI act, you have requested to be provided with the following for each of the approved COVID-19 vaccines:
-
- a) Evidence of continual monitoring carried out, and any investigations and reviews of the associated data
-
- b) Calculations and associated data of the positive benefit/risk
The MHRA continually monitors safety during widespread use of a vaccine and we have in place a proactive strategy to do this. There are four strands to the MHRA’s strategy, which combine to address the relative strengths and weaknesses of each form of vigilance. Through this strategy we are able to rapidly detect, confirm, and quantify any new risks and weigh these against the expected benefits. Further detail on the four main strands of our proactive vigilance can be found in the strategy linked above. Additionally, we work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects. Data are now available on the impact of the vaccination campaign in reducing infections and illness in the UK.The MHRA publishes a coronavirus vaccine weekly summary of Yellow Card reporting alongside analysis prints for each vaccine which can be found via this link. In this publication, you will find evidence of the continual monitoring carried out, as well as any investigations and reviews of the associated data. We update this on a weekly basis with the latest information. When assessing both the safety in specific populations and the specific safety topics, the benefit-risk balance of each COVID-19 vaccine is assessed to ensure it remains favourable. The expected benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects. As with all vaccines and medicines, the safety of COVID-19 vaccines is continuously monitored, and benefits and possible risks remain under review.I hope this information is useful to you and thank you again for getting in touch with us.Yours sincerely,FOI 22/019
27th January 2022
Dear,
Thank you for your Freedom of Information (FOI) request dated 30 December 2021 regarding the COVID-19 vaccines. Under the FOI act, you have requested to be provided with the following for each of the approved COVID-19 vaccines:
-
- a) Evidence of continual monitoring carried out, and any investigations and reviews of the associated data
-
- b) Calculations and associated data of the positive benefit/risk
The MHRA continually monitors safety during widespread use of a vaccine and we have in place a proactive strategy to do this. There are four strands to the MHRA’s strategy, which combine to address the relative strengths and weaknesses of each form of vigilance. Through this strategy we are able to rapidly detect, confirm, and quantify any new risks and weigh these against the expected benefits. Further detail on the four main strands of our proactive vigilance can be found in the strategy linked above. Additionally, we work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects. Data are now available on the impact of the vaccination campaign in reducing infections and illness in the UK.The MHRA publishes a coronavirus vaccine weekly summary of Yellow Card reporting alongside analysis prints for each vaccine which can be found via this link. In this publication, you will find evidence of the continual monitoring carried out, as well as any investigations and reviews of the associated data. We update this on a weekly basis with the latest information. When assessing both the safety in specific populations and the specific safety topics, the benefit-risk balance of each COVID-19 vaccine is assessed to ensure it remains favourable. The expected benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects. As with all vaccines and medicines, the safety of COVID-19 vaccines is continuously monitored, and benefits and possible risks remain under review.I hope this information is useful to you and thank you again for getting in touch with us.Yours sincerely,