FOI release

FOI Request

Case reference FOI2026/00825

Received 27 July 2026

Published 14 September 2026

Request

I am writing to request information under the Freedom of Information Act 2000 regarding the AstraZeneca COVID-19 vaccine, specifically batch number PV46662. This request is intended as an update to the information previously provided in FOI 22/713, which contained data up to 25 May 2022. I would be grateful if you could provide the same information using the most recent data available at the date this request is processed. Specifically, I request the following: 1. Total Adverse Reaction Reports * The total number of UK Yellow Card reports received for AstraZeneca COVID-19 vaccine batch PV46662 from the beginning of reporting to the most recent date available. 1. Breakdown of Adverse Reactions * An updated Vaccine Analysis Print (VAP) or equivalent document showing all reported suspected adverse reactions associated with batch PV46662. * Any accompanying guidance notes required to interpret the data. 1. Patient Ethnicity * An updated breakdown of adverse reaction reports by reported patient ethnicity, in the same format as provided in FOI 22/713. 1. Comparison with Other AstraZeneca Vaccine Batches * Please provide any analysis held by the MHRA comparing batch PV46662 with other AstraZeneca COVID-19 vaccine batches, including: * The total number of Yellow Card reports received for each batch (or the batches with the highest numbers of reports, if providing every batch would exceed the appropriate cost limit). * Any analysis comparing reporting rates between batches where the number of doses administered is known. * Whether batch PV46662 has been identified as having a higher, lower or expected rate of suspected adverse reaction reports compared with other AstraZeneca vaccine batches. * Details of any internal reviews, investigations, signal assessments or pharmacovigilance analyses undertaken specifically in relation to batch PV46662. * Whether PV46662 has ever been the subject of any batch-specific safety signal, investigation or enhanced monitoring, and if so, please provide details and the outcome of that assessment. 1. Ocular (Eye-Related) Adverse Reactions * Please provide details of all reported ocular or ophthalmic adverse reactions associated with batch PV46662, including: * The reported ocular adverse reaction terms (using MedDRA preferred terms where available). * The number of reports for each ocular adverse reaction. * The number of serious and non-serious reports for each ocular adverse reaction, where recorded. * Any MHRA signal assessments, reviews or conclusions specifically relating to ocular adverse reactions associated with this batch. 1. Fatal Outcomes * The number of Yellow Card reports associated with batch PV46662 that reported a fatal outcome, noting that a reported fatality does not imply causation. 1. Serious Adverse Reactions * The number of reports classified as serious, together with a breakdown of the seriousness criteria where available (e.g. hospitalisation, life-threatening event, disability, congenital anomaly, medically significant event or death). 1. Batch Distribution Information * If held by the MHRA, please provide: * The total number of doses from batch PV46662 supplied or administered within the UK. * If this information is not held by the MHRA, I would be grateful if you could confirm this and advise whether it is held by the UK Health Security Agency (UKHSA) or another public authority. 1. Regulatory Assessment * Please confirm whether the MHRA's current assessment remains that no batch-specific safety concerns have been identified for PV46662, or whether this assessment has changed since the response provided under FOI 22/713. * If the assessment has changed, please provide details of the evidence supporting that change. Where information is exempt from disclosure, I would be grateful if you could cite the specific exemption(s) relied upon and release any remaining information that is not exempt. Where possible, I request that the information be provided electronically in PDF or spreadsheet format. If any part of this request is likely to exceed the appropriate cost limit under the Freedom of Information Act, please advise me how the request may be refined so that the information can be provided.

Response

See attached

Documents

• DAP Guidance Sheet.pdf (119.5 KB)
• FOI2026_00825 (redacted).pdf (2.3 MB)
• FOI2026_00825 VAP.pdf (519.5 KB)

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