FOI release

Freedom of Information request on the yellow card reports from the COVID-19 vaccines (FOI 21/942)

Published 17 January 2022

16th September 2021

FOI 21/942

Dear

Thank you of your email dated 17th August where you requested:

1. The names of all agencies and corporations to whom the data in the Yellow Card database, used for recording COVID19 vaccine adverse events, is made available in whole or in part. For each agency and corporation, please list the categories of data made available.

2. A list of the quantitative scientific analyses that have been conducted to date that utilise data collected in the Yellow Card database of COVID-19 vaccine adverse events. For each of these analyses provide a title for the report, the name of the agency or corporation making the report, and a copy of, or link to the report in which these analyses can be found.

In response to question 1, once a submission of a suspected side effect is entered into our internal Sentinel database, it is available for further internal evaluation. Prior to 1st January 2021, a de-identified copy of the report was also sent to the European Medicines Agency’s (EMA) EudraVigilance database under reporting requirements in the European Pharmacovigilance Legislation, Directive 2010/84/EU and Regulation (EU) 1235/2010. In line with the legislation, this information was also be made available by the EMA to the World Health Organisation’s Uppsala Monitoring Centre and marketing authorisation holders (MAHs). Reports sent to EudraVigilance or the World Health Organisation’s Uppsala Monitoring Centre do not have identifiable reporter details or vaccinee initials. Since 1st January 2021, the MHRA has ceased sending the reports to EMA and shares data with MAHs and the World Health Organisation’s Uppsala Monitoring Centre directly, with the exception of reports from Northern Ireland.

This sharing of data is critical for several reasons.

• MAHs have a legal obligation to monitor adverse drug reaction reports for their specific portfolio of licenced drugs, this includes reports that have initially been reported to national regulators. This allows them to consider any changes to the benefit/risk balance and act, as necessary, to protect patients.

• International regulators conduct signal detection through both the WHO and European databases. Regulators can flag up possible safety concerns through international networks which may not otherwise be identified in smaller datasets.

• The UK additionally benefit from being able to review international data to support review of medicines safety, and thus the safety of patients in the UK.

• The current pandemic necessitates that we work with MAHs and other regulators to support continuous safety analysis of COVID-19 vaccines.

In response to question 2 as with any major new vaccination campaign, the MHRA always develops a proactive vigilance strategy. Through this strategy we are able to rapidly detect, confirm, and quantify any new risks and weigh these against the expected benefits. We can then take any necessary action to minimise risks to individuals. We also 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. The outcomes of our assessment can be found in our summary of Yellow Card reporting relating to the COVID-19 vaccines which is published each week and can be found here. The summary includes data analysis on reported suspected adverse reactions from the COVID-19 vaccines.

Please be reassured that the MHRA takes all reports of adverse reactions with the utmost seriousness. Where these events are reported to us, we follow up to find out full details of the events and the cause of death and, where applicable, further information of any post-mortem findings. Once received, we look at each individual adverse drug report to individually assess each case, together with additional sources of evidence, by a team of safety experts. Additionally, we apply statistical techniques that can tell us if we are seeing more events than we would expect to see, based on what is known about background rates of illness in the absence of vaccination. This aims to account for factors such as coincidental illness. We also look at the clinical characteristics to see if new patterns of illness are emerging that could indicate a new safety concern. We also monitor deaths rates over time and the information is thoroughly analysed for patterns or evidence which might suggest a causal link between the vaccination and the death.

We supplement this form of safety monitoring with other epidemiology studies including analysis of data on national vaccine usage, anonymised GP-based electronic healthcare records and other healthcare data to proactively monitor safety. Furthermore, we also take into account the international experience based on data from other countries using the same vaccines. We also receive independent advice from the Commission on Human Medicines (CHM) which is responsible to advise on the impact of any safety issues including fatal cases 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

With regards to your request in question 2 for a list of scientific analyses I can confirm that the MHRA does hold some of the information that you have requested. However, we have also determined that the information is exempt under Section 12 of the Freedom of Information Act and we cannot process your request any further.

Section 12 of the Act allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information.

As we do not hold our analyses in the format requested, in order to process your request, we would need to review approximately 360,000 reports. We therefore consider the time to retrieve and review this information would exceed the aforementioned cost limit of £600 and 24 working hour time limit.

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