FOI release

Freedom of Information request on Yellow Card reporting (FOI 21/730)

Published 29 December 2021

27th July 2021

FOI 21/730

Dear

Thank you of your email dated 28th June 2021, where you requested the following:

1. Regards the latest Yellow Card Report issued at the time this request is reviewed and responded to, please provide an analysis of the deaths and adverse reactions recorded relative to the persons gender and age? Likewise, re deaths only, please advise of the occupations of the deceased <60 years old?
2. Regards categories, what is the descriptive narrative (including how are deaths designated to these categories) relative to: spontaneous births; still births; foetal death; premature baby listed as a fatality and sudden death?
3. Please provide the gender, age, and occupation (if <60 years) of the one fatality listed in the suicide category. Was this report from a member of the public or from a healthcare professional?

Regarding your first question, you requested analysis of the deaths and adverse reactions recorded relative to the persons gender and age. The MHRA intend to publish all suspected reactions (including those with a fatal outcome) 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 this section 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 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.

Furthermore, the MHRA cannot provide a breakdown of patient occupation as requested because we do not hold this information. Upon submission of a Yellow Card report, the MHRA only request the reporter’s qualification, i.e. the person who submitted the Yellow Card report.

In regards to your second question about how Adverse Drug Reactions (ADRs) are designated into categories such as spontaneous birth, still births, foetal death, premature baby and sudden death, I can confirm that the ADRs and their corresponding outcomes (for example fatal, not recovered) are coded based on what the original reporter has submitted within their Yellow Card report to us. Reporters are able to select the most relevant terms when completing a Yellow Card report.

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.

In regard to your final question about completed suicide cases, the MHRA are unable to provide further details on the patient due to confidentiality reasons. As there are less than five cases, providing further information would risk patient identification. However, I can confirm that as of 7th July, of the 3 completed suicide reports submitted following AstraZeneca COVID-19 vaccinations, one was from a healthcare professional and two were from members of the public. We have not received reports of fatal completed suicide following Pfizer or Moderna COVID-19 vaccinations.

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