FOI release

Freedom of Information request on yellow card reports for COVID-19 vaccines (FOI 21/801)

Published 20 January 2022

25th August 2021

FOI 21/801

Dear

Thank you for your response to your Freedom of Information request (FOI 21/577) dated 23 July 2021, where you asked for additional information on the following:

1. How are the Yellow Card reports of suspected adverse drug reactions evaluated?

2. What additional sources of evidence are used?
3. Who are the members of the team of safety experts used to identify any new safety issues or side effects?
4. What statistical techniques do you apply which can tell if you are seeing more events than you would expect to see, based on what is known about background rates of illness in the absence of vaccination.
5. How do you define coincidental illness?
6. How do you review clinical characteristics to see if new patterns of illness are emerging that could indicate a new safety concern?

I am pleased to provide you with the information requested, below.

Questions 1, 2 and 3

The safety monitoring process for COVID-19 vaccines is outlined in the COVID-19 Vaccine Surveillance Strategy which was provided in our previous response (FOI 21/577). Please follow this link to the document: COVID-19 Vaccine Surveillance Strategy. Information surrounding the analysis of Yellow Card reports can be found under the section titled Enhanced passive surveillance – ‘observed vs expected’ analysis.

Question 2

As stated in FOI 21/577, 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.

We also work closely with our public health partners in reviewing the effectiveness and impact that the vaccines are having to ensure benefits continue to outweigh any possible side effects. In addition, and as mentioned, we work with our international counterparts to gather information on the safety of vaccines in other countries.

Further information on all four main strands of our proactive vigilance can be found within the COVID-19 Vaccine Surveillance Strategy referenced above.

Question 3

MHRA safety experts are made up of doctors, pharmacists and scientists who study the benefits and risks of medicines.

Question 4

As outlined in the COVID-19 Vaccine Surveillance Strategy; the MHRA uses an established statistical approach known as empirical Bayes geometric mean (EBGM) to facilitate signal detection. Further details on all the statistical analyses are outlined in the section entitled: Proactive vigilance for COVID-19 vaccines.

Question 5 and 6

We encourage reporters to report suspected ADRs i.e. the reporter does not have to be sure of a causal association between the vaccination and the reactions – a mere suspicion will suffice. Therefore, reports submitted to the MHRA may be true side-effects or they may be due to concurrent diagnosed or undiagnosed illness, other medicines, or they may be purely co-incidental, i.e. events that would have occurred anyway in the absence of vaccination.

The COVID-19 Vaccine Surveillance Strategy describes the four main strands of our proactive vigilance strategy. These methods allow us to identify side-effects, and distinguish these from coincidental medical events.

I hope the information provided is helpful.

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