FOI release

Freedom of Information request on the adverse reactions reported of vCJD transmission via any blood products (FOI 22/613 & FOI 22/620)

Published 27 March 2023

FOI 22/620, FOI 22/613

11th May 2022

Dear

Thank you for your emails dated 11th and 12th April 2022, where you asked for information on the following:

“I am writing to ask if you have received any reports of any alleged or suspected cases of vCJD transmission via any blood products recently.”

“List of issues related to the Rabipur rabies vaccine and HyperRAB S/D rabies human immunoglobulin which were reported to the MHRA between 01 January 2008 and 01 April 2022. I am interested in reports concerning serious adverse reactions, manufacturing defects, issues related to the plasma pools as well as any other major safety issues associated with these products. For each issue reported, I am also requesting for information regarding affected lot numbers, manufacture and expiry dates, countries the lots were exported to, date of administration and whether there were any associated deaths or serious injuries, if such information is available.”

You may be aware that the MHRA collects reports of suspected side effects through the Yellow Card scheme, which collects and monitors information on suspected safety concerns involving a healthcare products. As the MHRA is the regulatory authority for the United Kingdom and is therefore only able to accept reports of adverse drug reactions from within our jurisdiction, your report has not been added to our database. We would like to take this opportunity to encourage you to report your experience to the regulatory authority for Singapore if you haven’t already (https://www.hsa.gov.sg/adverse-events).

As per your request for a list of issues related to the Rabipur rabies vaccine and HyperRAB S/D rabies human immunoglobulin which were reported to the MHRA between 01 January 2008 and 01 April 2022, please find attached a Vaccine Analysis Print (VAP) for the Rabipur vaccine which contains all UK spontaneous suspected Adverse Drug Reaction (ADR) reports received between 01/01/2008 and 01/04/2022 in association with this product.

Please note that HyperRAB is not authorised in the UK and we have no UK ADR reports for this product, however the interactive Drug Analysis Print for Rabies Immunoglobulin is available on the MHRA website (http://yellowcard.gov.uk/iDAP/). Each iDAP contains complete data for all spontaneous suspected adverse drug reactions, or side effects, which have been reported on that drug substance to the MHRA, via the Yellow Card scheme from healthcare professionals and members of the public. They also include reports from pharmaceutical companies. I can confirm that the MHRA has received no reports of vCJD in association with either the Rabipur vaccine or Rabies Immunoglobulin. Please consult the iDAPs for further reports of suspected side effects of variant Creutzfeld-Jakob disease (vCJD) associated with other blood products.

The VAP contains complete data for all spontaneous suspected adverse drug reactions, or side effects, including those which are associated with a fatal outcome. Please refer to the attached information sheet for guidelines on how to interpret the VAP.

When considering the attached spontaneous 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 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. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.

• Additionally, 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.

You also requested reports of manufacturing defects, issues related to the plasma pools or major safety issues for the Rabipur rabies vaccine and HyperRAB S/D rabies human immunoglobulin. The MHRA has not identified any manufacturing defects, issues related to the plasma pools or major safety issues with these products. The MHRA undertook a review regarding use of UK plasma for the manufacture of immunoglobulins and vCJD risk in 2020 which concluded that the use of plasma from UK donors for the manufacture of human Ig products would expose the target patient population to no or minimal additional risk of vCJD in the future. The full review is available at https://www.gov.uk/government/publications/critical-risk-assessment-report-use-of-uk-plasma-for-the-manufacture-of-immunoglobulins-and-vcjd-risk/critical-risk-assessment-report-use-of-uk-plasma-for-the-manufacture-of-immunoglobulins-and-vcjd-risk#overall-conclusion

Finally, you requested information regarding affected lot numbers, manufacture and expiry dates, countries the lots were exported to, date of administration and whether there were any associated deaths or serious injuries. As confirmed above, the MHRA has not identified any manufacturing defects, issues related to the plasma pools or major safety issues with these products.

Regarding the Rabipur VAP we have provided to you, we are unable to provide you with the batch number and date of administration for each of these ADR reports as this is covered under Section 40 and 41 of the Freedom of Information Act and is therefore exempt from disclosure. Section 40 (personal information) protects personal data, the disclosure of which would breach one or more of the data protection principles. The Agency is satisfied that disclosure here would breach the first data protection principle, in particular the requirement of fairness on the basis that disclosure would not be reasonably expected by the people mentioned in the information. Section 41 relates to information provided to us in confidence, with the expectation that it will not be released. Information will be covered by Section 41 if it was obtained by the authority from any other person; its disclosure would constitute a breach of confidence; a person or organisation could bring a court action for that breach

of confidence; and that court action would be likely to succeed. We can confirm that all of these ADR reports are from the United Kingdom. The MHRA do not routinely collect data on vaccine manufacture and expiration date within Yellow Card reports so are unable to provide you with this information as it concerns information we no not hold.

Should you wish to review additional information on any specific cases please note that under the FOI act, we can only release FOI Category 1b data for Yellow Card data which includes the following:

Aggregated patient age

Aggregated patient gender (number of males and females)

Suspect drug(s)

Dose of suspect drug

Route of administration Duration of treatment

Suspected adverse drug reaction(s)

Outcome of reaction

Reaction onset times

Patient medical history

Year of receipt

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