FOI release

Freedom of Information request on yellow card report data for COVID-19 vaccines (FOI 22/775)

Published 21 December 2023

FOI 22/775

15th July 2022

Dear

Thank you for your correspondence via the MHRA Yellow Card Contact Us Form on 17th June 2022.

You have requested to be provided with the following:

• Typical number of doses per Pfizer COVID-19 batch number.

• Median number of ADR reports across all Pfizer COVID-19 batch numbers.

• Highest number of ADR reports for a single Pfizer COVID-19 batch number also please specify the batch number.

• Number of ADR reports for each of the following Pfizer COVID-19 batch numbers: EJ0553 and ER1741

To provide some background, the MHRA continuously monitors the safety of vaccines through a variety of pharmacovigilance processes including the Yellow Card scheme. As part of our signal detection processes all adverse reaction reports received by the Yellow Card scheme are assessed and cumulative information reviewed at regular intervals. Vaccines encompass a wide variety of products with different indications, different ingredients and different mechanisms of action and as such safety for each vaccine is considered individually rather than as a group.

In response to your question about the typical number of doses per COVID-19 vaccine Pfizer/BioNTech batch number, I can confirm that this is not information that the MHRA hold. Please contact the UK Health Security Agency (UKHSA) directly at enquiries@ukhsa.gov.uk

As per your request, a search has been conducted within our database up to and including the 29th of June 2022 across all COVID-19 vaccine Pfizer/BioNTech UK spontaneous suspected Yellow Card reports for all reported batch numbers. Table 1 contains information on the top 10 most commonly reported batch numbers within all UK spontaneous suspected ADR reports for the COVID-19 vaccine Pfizer/BioNTech vaccine received through the Yellow Card scheme for this time period.

Table 1: The number of UK spontaneous suspected ADR reports relating the top 10 most commonly reported batch numbers up to and including 29/06/2022

Batch Number	Total number of ADR reports
ER1741	4306
ER1749	3633
EW4109	3243
ET8885	2858
EW3143	2630
EL0739	2408
FA1027	2334
EM4965	2328
EK1768	2062
EE8492	1998

Finally, please see Table 2 for the number of ADR reports the COVID-19 vaccine Pfizer/BioNTech vaccine batch numbers EJ0553 and ER1741 received through the Yellow Card scheme.

Table 2: The number of UK spontaneous suspected ADR reports relating to the COVID-19 mRNA Pfizer/BioNTech vaccine batch numbers EJ0553 and ER1741 up to and including 29/06/2022

Batch Number	Total Number of ADR Reports
EJ0553	1264
ER1741	4306

When considering all the data provided, it is important to note that the accuracy of the data relies on the batch number correctly being provided by the reporter on the Yellow Card. Please note that the data above will only contain the numbers of reports where that batch number is specifically reported and will not contain entries where there may be typographical errors or other information entered into that field in error in the original report. It is also important to note that whilst we encourage reporters to provide as much detail as possible about the vaccine, the batch number is not a mandatory field on the Yellow Card and may not always be reported. Therefore, the number of reports provided may not be a true reflection of the number of Yellow Card COVID-19 vaccine reports submitted for the respective batches.

In addition, not all batches of the COVID-19 vaccines are the same size, and some batches may have had more wastage than other batches or be distributed more widely outside of the UK. Therefore, we would not expect the number of ADR reports for all batches to be the same as they have been administered to different numbers of patients.

Furthermore, different batches would have been used at different stages of the vaccination campaign, and in different patient groups, which could also impact reporting rates. For example, reporting rates were typically higher at the beginning of the vaccination campaign as individuals received their first dose and the likelihood of experiencing a reaction, as well as the propensity to report it, differs across patients of different ages. Please note that our analysis of these reports, which takes into account product batch number, did not result in any safety concerns. Please be assured that the MHRA reviews this data regularly and we would communicate any concerns raised with the public and healthcare professionals. If you would like further information on batch usage, please contact the UK Health Security Agency (UKHSA) who hold this information.

Also, to note, when reviewing the spontaneous ADR data provided, it is important to be additionally 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. The fact that symptoms occur after use of a vaccine, and are reported via the Yellow Card Scheme, does not in itself mean that they are proven to have been caused by the vaccine. 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. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, and may be stimulated by promotion and publicity about a drug.

As these data do not necessarily refer to proven side effects, you should refer to the product information which can be found here: Product Information - Coronavirus (COVID-19) (mhra.gov.uk) for details on the possible side effects of each vaccine.

You requested a calculation of the median number of ADR reports across all Pfizer batch numbers. Batch numbers are not always provided by reporters and additionally, individuals sometimes enter information that does not correspond to a deployed batch number or may enter a batch number incorrectly. Such reports would be included in the calculation of the median and therefore is not a statistically robust approach to analysis and is not calculated by the MHRA. As such, this cannot be provided under FOI because it is not held.

The MHRA has been proactively monitoring the safety of all approved COVID-19 vaccines for near real-time safety monitoring at the population level. A summary of Yellow Card reporting relating to the COVID-19 vaccines is updated regularly and can be found here. The summary includes data analysis on reported suspected adverse reactions from the COVID-19 vaccines.

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