FOI release

Freedom of Information request on the adverse reactions reported following the AstraZeneca COVID-19 vaccine specifically for batch number PV46662 (FOI 22/713)

Published 21 December 2023

FOI 22/713

22nd June 2022

Dear

Thank you for your email on 20th May 2022, where you requested the following information for the COVID-19 vaccine AstraZeneca with the batch number PV46662 for the period 2020 to present:

1. The number of reported adverse reactions

2. Number of non-white patient’s reporting these reactions

3. A breakdown of the adverse reactions

The MHRA continuously monitors the safety of vaccines through a variety of pharmacovigilance approaches 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.

Further to your request, as of the 25th May 2022 we can confirm that the MHRA have received a total of 3,105 UK spontaneous suspected adverse reaction reports to the Yellow Card Scheme reporting the COVID-19 vaccine AstraZeneca with the batch number PV46662. Please also find attached a Vaccine Analysis Print (VAP) for the COVID-19 vaccine AstraZeneca with the batch number PV46662. The VAP provides a breakdown of the reported adverse reactions. A VAP guidance sheet is also enclosed which provides you with further information on how to interpret the print.

The data provided includes all reports that contain “PV6662” in the batch number field of the COVID-19 vaccine AstraZeneca on the Yellow Card report. Please note that the accuracy of the data relies on the batch number correctly being provided by the reporter on the Yellow Card and that the data will not contain entries where there may be typographical errors 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.

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 the Yellow Card reports detailed in this response, which takes into account product batch number, did not result in any safety concerns. Please be assured that the MHRA reviews Yellow Card 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.

In reference to your second question, Table 1 below provides a breakdown of the number of UK spontaneous suspected adverse reaction reports received for the COVID-19 vaccine AstraZeneca with the batch number PV46662 broken down by reported patient ethnicity. It is also important to note, that whilst we encourage reporters to provide as much information as possible about the patient, patient ethnicity is not a mandatory field, and therefore, may not always be reported.

Table 1: UK Spontaneous suspected adverse reaction reports received broken down by patient ethnicity for the COVID-19 vaccine AstraZeneca with the batch number PV46662

Patient Ethnicity	Number of reports
African	15
Any other Asian Backgroun	17
Any other black background	*
Any other ethnic background	6
Any other mixed background	18
Any other white background	136
Bangladeshi	*
British	2,148.00
Caribbean	11
Chinese	10
Indian	46
Irish	42
Not known/ not stated	12
Pakistani	9
White & Asian	12
White & Black African	*
White & Black Caribbean	11
Not reported	603

*Please note that where the total number of reports is <5, the total has been removed in order to protect patient confidentiality.

When considering the spontaneous ADR data detailed above, it is important to be 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 or events 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 vaccines. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.

• It is also important to note that Yellow Card data cannot be used to determine the incidence of a reaction or to compare the side effect profiles of different medicines or vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug or vaccine and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced medicines or vaccines during the first one to two years on the market and then falls over time.

As this data does not necessarily refer to proven side effects, you should refer to the product information (Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL)) for details on the possible side effects of each COVID-19 vaccine, which can be found on the Yellow Card coronavirus website here.

I would like to take this opportunity to draw your attention to the Coronavirus vaccine – weekly summary of Yellow Card reporting, which is updated regularly and available here. This document may be of use to you as it contains details of all ADR reports pertaining to the COVID-19 vaccines received via the Yellow Card Scheme, as well as summaries of our assessment on particular safety topics surrounding the COVID-19 vaccinations.

As with all vaccines and medicines, the safety of COVID-19 vaccines is continuously monitored and benefits and possible risks remain under review. Our advice remains that the benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh the risks in the majority of people,

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 this response’s date and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division