FOI release

Freedom of Information request for adverse reactions associated with specific vaccine batches (FOI 21-343)

Published 28 June 2021

5th May 2021 FOI 21/343

Thank you for your FOI request dated 2nd April 2021, where you requested if the following batch numbers have been reported and the number of adverse reactions (including a breakdown of reaction details) and whether Audibert Soulie A and Miller & Miller Chemicals are not marketing authorisation holders for any vaccines authorised by MHRA.: • 110069F • A20CA766A • F73747 • F49080 • F83366 • A76CA221A • A69CD167A • G47544 • A20CB284A • M037340 MHRA refuses to confirm or deny whether either company is involved in the manufacturing or supply of the vaccines under Section 41 (information provided in confidence) and Section 43 (commercial interests) of the FOI Act.

Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.

Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in providing information that can be used by competitors for their commercial advantage. Examples of public interest arguments would be a major public health risk or a major procedural failure or irregularity. Yellow Card data is releasable to members of the public provided that patient and reporter confidentiality is maintained. Under the Freedom of Information Act (FOIA) 2000, the data for this request has been provided as category Ib. For this FOI, the line listings contain the following fields:

• Patient age categories (as aggregated data) • Patient gender categories (as aggregated data) • Suspect drug(s) • Dose of suspect drug(s) • Route of administration • Suspected adverse drug reaction(s) • Adverse drug reaction outcome(s) • Time to onset • Past medical history

I can confirm we have received a total of 12 spontaneous UK suspected ADR reports in relation to the specified batch numbers as of 29/04/2021. The information is presented as a line listing (Table 1a) and aggregated patient age and sex (Tables 1b and 1c) When considering the spontaneous Adverse Drug Reaction (ADR) data, 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. Each year, millions of doses of routine vaccines are given in the UK alone, and when any vaccine is administered to very large numbers of people, some recipients will inevitably experience illness following vaccination. 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 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. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time. • Furthermore, as reporting batch numbers for a suspected drug is not a mandatory field, we have only included cases which did report the batch numbers requested. Any emerging evidence relating to possible risks associated with vaccines and medicines, is carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed. As these data do not necessarily refer to proven side effects, you should refer to the product information which can be found here: https://www.medicines.org.uk/emc/ for details on the possible side effects of the vaccine. However, from the data I can confirm that the most commonly reported reactions are known possible adverse reactions associated with the vaccines and are listed as such in the vaccine’s product information. 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 individually assessed and cumulative information reviewed at regular intervals.

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