FOI release

Freedom of Information request on adverse reactions following COVID-19 vaccination (FOI 21/834)

Published 20 January 2022

18th August 2021

FOI 21/834

Dear

Thank you for your email dated 20th July 2021, where you asked:

“Please can you provide me with the number of people who have died within 12 weeks of their first dose of any covid vaccine and 12 weeks after their second dose of any covid vaccine.

Please could you provide me the number of miscarriages 12 weeks after the first dose of any covid vaccine and 12 weeks after their second dose of any vaccine.

Please could you provide me the number of cardiac arrest, heart attacks, heart inflammation seen in people under 40 within 12 weeks of their first Covid vaccine and within 12 weeks of their second Covid Vaccine.

Please could you provide me the number of deaths within 12 weeks from influenza vaccine administered in the last 5 years”

Question 1 & 4:

We can confirm that we do not hold this information as we do not collect complete fatality data. We suggest you contact the Office for National Statistics for death statistics, please find below contact details:

Email: [email protected]

Reports received through our Yellow Card scheme including events with a fatal outcome can be viewed for the COVID vaccines by following the link below:

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

Question 2:

The MHRA publishes information on the numbers and types of suspected adverse drug reactions received following each of the COVID-19 vaccines authorised and used in the UK on our website, as referenced above. This information is updated weekly to reflect any new and emerging safety concerns, along with details of any regulatory actions taken by the MHRA or changes in the advice on safe and effective use of the vaccines.

When considering the spontaneous data, it is important to be aware of the following points:

• A reported reaction does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have. Each year, millions of doses of routine vaccinations are given in the UK alone, and when any vaccine is administered to large numbers of people, some recipients will inevitably experience illness following vaccination. The fact that symptoms occur after use of a vaccine or medicine, and are reported via the Yellow Card Scheme, does not in itself mean that they are proven to have been caused by it. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.
• It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction or compare the safety profile of different vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular medicine, and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.
• It is important to note that when submitting a Yellow Card, reporters may report the time to onset as the time when the first symptoms began, the time at which an admission occurred or a diagnosis. The MHRA consider all ADR reports in our ongoing analysis regardless of time to onset and look at a range of risk windows in our statistical analysis; we never exclude a case.

The total number of miscarriages (listed under spontaneous abortion) can be found within the associated Vaccine Analysis Print (VAP) for each vaccine. In relation to reports of miscarriage, pregnancy loss prior to 22 weeks is classified as a miscarriage within a Yellow Card report, whereas after 22 weeks this is captured as still birth or foetal death. By convention miscarriages are not classed as fatal as the term relates to the mother rather than the child. Please note we routinely review and update cases to ensure information is accurately captured on our database, so published numbers may change over time.

As pregnant women were not included in the clinical trials which led to the authorisation of the above vaccines, information on pregnancy outcomes, including miscarriage, is being closely monitored by the MHRA, and other medicines regulators like the Food and Drug Administration (FDA) in the United States (US) and the European Medicines Agency (EMA) in Europe, through spontaneous reporting systems and via registries of people who received the vaccine whilst pregnant. Since the launch of the COVID-19 immunisation campaign, we have been proactively monitoring the safety of all approved COVID-19 vaccines for near real-time safety monitoring at population level.

The MHRA plan to publish a breakdown of data by first and second dose in future. As we plan to publish the data, we consider that this part of your request is covered by Section 22 of the Freedom of Information Act (information intended for future publication) and the information you have asked for by dose is therefore exempt from disclosure.

Section 22 is a qualified exemption which means we have considered whether there is a greater public interest in releasing the information requested or withholding it. We recognise there is strong interest in seeing this data and accept it should not be withheld however wish to publish this information alongside appropriate context and assessment.

Question 3:

Please refer to the link provided in Question 2 for the total numbers of reports concerning cardiac arrest, heart attack and heart inflammation broken down by COVID-19 vaccine.

The MHRA intend to publish all suspected reactions reported in association with available COVID-19 vaccines in an interactive format as interactive Drug Analysis Profiles (iDAPs), along with our ADR summary that is published each week. The use of iDAPs will enable users to view the data by categories of their choice such as age, sex and seriousness of reports. Users will also be able to download the data tables in CSV format.

As we plan to publish the data, we consider that your request is covered by Section 22 of the Freedom of Information Act (information intended for future publication) and the information you have asked for by age category is therefore exempt from disclosure. The information requested regarding dose is also exempt based on the reason listed above.

As mentioned above, Section 22 is a qualified exemption which means we have considered whether there is a greater public interest in releasing the information requested or withholding it. We recognise there is strong interest in seeing this data and accept it should not be withheld however wish to publish this information alongside appropriate context and assessment.

We will send you a link to the iDAPs once they are published.

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