FOI release

Freedom of Information request on adverse reactions following COVID-19 vaccination (FOI 21/744)

Published 29 December 2021

28th July 2021

FOI 21/744

Dear

Thank you for your email dated 30th June 2021 in which you referenced the preliminary report of Yellow Card data issued by the UK-based Evidence-Based Medicine Consultancy Ltd submitted to the MHRA.

We would like to emphasise that the nature of Yellow Card reports means that reported events are not always proven side effects. Some events may have happened coincidentally, regardless of vaccination. This is particularly the case when millions of people are vaccinated. Individual reports to the scheme are highly likely to contain more than one reaction and therefore it is not always appropriate to sum the number of reactions from the published analysis prints. It is important to evaluate reports in context of any other information provided within the report and alongside evidence from other sources.

The MHRA’s role is to continually monitor safety during widespread use of a vaccine. We have in place a proactive strategy to continually monitor the safety of COVID-19 vaccines, and through this strategy we are able to rapidly detect, confirm, and quantify any new risks and weigh these against the expected benefits. Further details on our strategy can be found here. We also receive independent advice from the Commission on Human Medicines (CHM) which is responsible for advice on the impact of any safety issues and on the balance of risks and benefits of COVID-19 vaccines. For further information on the CHM please follow this link:

https://www.gov.uk/government/organisations/commission-on-human-medicines/about

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. You may also be interested to know that the MHRA publish a weekly summary of Yellow Card reporting for the COVID-19 vaccines which can be found here.

You have also asked three specific questions within your correspondence to which the responses are provided below:

• How many people have died within 28 days of vaccination?
• How many people have been hospitalised within 28 days of vaccination?

We collect information on suspected adverse reactions, including those with a fatal outcome, in association with medicines including COVID-19 vaccines. Reports received via the Yellow Card scheme can be reported at any time after a suspected side effect has occurred. Additionally, the timeframe from when the patient received the COVID-19 vaccine to experiencing a suspected side effect is not always provided by the reporter. The Office for National Statistics (ONS) may be able to help further with this request.

We take all reports received via the Yellow Card scheme seriously and review all reports of suspected ADRs with a fatal outcome regardless of the time to onset from receiving a medicine or vaccine. We follow up reports including all fatalities where permission has been provided to do so for further information including the length of time since the deceased received the vaccine if that has not already been provided. As with any serious suspected ADR, we fully evaluate reports with a fatal outcome to consider whether the vaccine (or medicine) may have caused the event, or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness.

• How many people have been disabled by the vaccination?

We are unable to comment on the number of people left disabled as a result of a COVID-19 vaccination as Yellow Card reports do not detail functional outcomes for patients, particularly in the medium to long term, to be able to assess the level of disability for any patient that might have been experienced ADRs following COVID-19 vaccination. You will be best placed to direct this particular question to Public Health England (PHE).

Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19. All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness. Following widespread use of these vaccines across the UK, the vast majority of suspected adverse reaction reports so far confirm the safety profile seen in clinical trials. 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 the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division