FOI release

Freedom of Information request on the Drug Analysis Prints (DAPs) for vaccines (FOI 21/1164)

Published 26 May 2022

FOI 21/1164

24th November 2021

Dear,

Thank you for your initial email dated 15th October 2021 and your subsequent follow-up email dated 26th October 2021, where you requested the Drug Analysis Prints (DAPs) for the following vaccines:

• • • AstraZeneca and Pfizer COVID-19 vaccines
• • • Flu vaccines 2020 and 2021 (both live and inactivated)
• • • Infanrix Hexa (DTaP/IPV/Hib/HepB)
• • • Bexsero (Meningitis B)
• • • Menitorix (Hib/MenC)
• • • MMR VaxPRO 2 (MMR)
• • • Priorix (MMR)
• • • Gardasil (Human papillomavirus)
• • • Prevenar 13 (Pneumococcal conjugate vaccine)
• • • Revaxis (Td/IPV)
• • • Nimenrix (Meningococcal groups A, C, W and Y disease)
• • • Menveo (Meningococcal groups A, C, W and Y disease)
• • • BCG (Bacillus Calmette–Guérin)
• • • Engerix B (Hepatitis B)
• • • HBVaxPRO (Hepatitis B)

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.

As per your request, I would like to kindly direct you to the enclosed DAPs for the list of vaccines you requested. Please also find attached a DAP guidance sheet which provides you with further information on how to interpret the prints. The prints contain information on all UK spontaneous suspected Adverse Drug Reaction (ADR) reports received through the Yellow Card scheme up to and

including 17/10/2021. Please note that these data include reports received for all brands of each vaccine as well as reports in which the brand name was not provided by the reporter. For example, the data in the MMR DAP includes reports relating to all MMR vaccines including Priorix, MMR VaxPRO and reports in which an MMR vaccine was reported but a brand name was not provided. If you require a DAP for a specific brand of vaccine, please email pharmacovigilanceservice@mhra.gov.uk.

We have included a DAP for the live influenza vaccine and the inactivated influenza vaccine which contains UK spontaneous suspected ADR reports received from 01/01/2020 to 17/10/2021. Please note that reports received over this time period does not necessarily mean that the vaccine was administered at that time.

We have not enclosed a print for the COVID-19 Pfizer/BioNTech Vaccine or the COVID-19 Vaccine AstraZeneca as we currently publish a summary report for all COVID-19 vaccines here) alongside Vaccine Analysis Prints (VAPs) for each of these vaccines which provide a list of reactions reported.

When considering the attached spontaneous 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 vaccinations are given in the UK alone, and when any vaccine is administered to large numbers of people, some recipients will inevitably experience illness following vaccination. The fact that symptoms occur after use of a vaccine or medicine, and are reported via the Yellow Card Scheme, does not in itself mean that they are proven to have been caused by it. 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 or compare the safety profile of different vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular medicine, 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.

As these data do not necessarily refer to proven side effects, you should refer to the product information which can be found here: https://products.mhra.gov.uk/ for details on the possible side effects of each vaccine. In addition, you can also find the product information for the Pfizer/BioNTech and AstraZeneca COVID-19 vaccine on the Yellow Card Coronavirus website.

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.

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