FOI release

Freedom of Information request on the adverse reactions relating to all vaccines by age via the Yellow Card scheme (FOI 21/960)

Published 17 January 2022

17th September 2021

FOI 21/960

Dear

Thank you for your email on the 19th August 2021, where you requested the following under the Freedom of Information Act:

• A breakdown of events with a fatal outcome after a COVID vaccine by age group

• A breakdown of adverse reactions to the vaccine by age

• The number of menstrual disorder reactions to the COVID-19 vaccine compared to the number of women of ‘menstruating age’ as opposed to all women which the current comparison figure

• You state the number of deaths with ‘shortly after vaccination’ can you please confirm the timeframe being used?

• The Yellow Card report states you cannot confirm or rule out a casual relationship between the vaccine and GBS, what is being done currently to confirm or rule out this? Is there a timeframe for when this will be looked into further and confirmed?

Further to your first and second point requesting a breakdown of events associated with a fatal outcome by age group as well as a breakdown of adverse reactions to the COVID-19 vaccines by age. We 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. 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 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. The current published data can be accessed here:

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

With regards to your third point on the number of menstrual disorder reactions associated with the COVID-19 vaccination compared to the number of women of a ‘menstruating age’ opposed to all women, I can confirm the MHRA do not hold data on vaccine uptake within specific groups. For data on how many women of a ‘menstruating age’ have received the vaccine we would encourage you to contact Public Health England.

Further to your fourth point, ‘shortly after the vaccination’ typically signifies within 28 days of receiving the COVID-19 vaccine. The duration of up to 28 days aligns with other government data on COVID-19 fatalities in the UK. Reports received via the Yellow Card scheme can be reported at any time after a suspected side effect has occurred. Additionally, the time frame from when the patient received the vaccine to experiencing a suspected side effect is not always provided by the reporter. We review and published all reports of death regardless of the time to onset from receiving a medicine or vaccine.

Finally, you asked about the relationship between Guillain-Barré syndrome (GBS) and the COVID-19 vaccinations. The MHRA has been closely monitoring and assessing cases of GBS reported following administration of the COVID-19 vaccines and as you mentioned, based on the available evidence, we are not able to confirm or rule out a causal relationship with the vaccines. We recommend that you follow our COVID-19 vaccination page which is updated every week for any further updates. Following advice from the government’s independent advisory body, the Commission on Human Medicines (CHM) and its COVID-19 Vaccines Benefit Risk Expert Working Group, the product information for the COVID-19 Vaccine AstraZeneca has been updated to include a precautionary warning that Guillain-Barré Syndrome has very rarely been reported following vaccination. The update alerts healthcare professionals and patients of the potential risk of developing GBS and any signs to allow early diagnosis and treatment. Patients are advised to seek immediate medical attention if they develop weakness and paralysis in the extremities that can progress to the chest and face. The MHRA continuously reviews cases of GBS reported following vaccination with COVID-19 vaccines to further assess a possible association between GBS and COVID-19 AZ vaccine, with independent advice from its Vaccine Benefit-Risk Working Group. The product information of Vaxzevia will be updated based on relevant new evidence and you can follow these updates at the following links : https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca/information-for-healthcare-professionals-on-covid-19-vaccine-astrazeneca. The benefit/risk profile of the vaccination remains unchanged.

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