FOI release

Freedom of Information request on the information on the specific batch recall from Novartis (FOI 22/765 & FOI 22/734)

Published 4 January 2024

FOI 22/765 & FOI 22/734

26th July 2022

Dear

Please accept our apologies for the delay in response. We would like to thank you for your patience and email dated 14th June 2022, where you asked for information on the following:

“1. The actual notification document which Novartis sent to the MHRA detailing the recall of the mentioned batches (490011C, 493011A), when this notification was received, and when it was first announced by the MHRA to the public. 2. Record of any particular reason why the publication date of this recall on the above link is 17 December 2014, more than two years after the actual recall by Novartis (stated as 21 March 2012 in the above link) 3. Any document specifying the exact type of mould present in the packaged syringes, what caused the mould (e.g. fungi, bacteria or other micro-organism) and any associated laboratory results.

You also requested additional information for the questions below:

4.Any similar documents (recall notifications, details of suspected contamination, laboratory results, etc.) related to Rabipur lots 490011F and lots 493011K, also recalled in 2012. 5. Any information the MHRA may have on which countries these lots (490011C, 493011A, 490011F, 493011K and 495011A) were sent to (in addition to the UK)“

With regards to questions 1, 4 and 5 above, I can confirm that this information is exempt from release 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 would consider the release of this information to be an actionable breach of confidence. Section 43 is a qualified exemption and a consideration of the public interest is required. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in releasing information on products that have not yet been authorised for use and are still under development. This information can be used by competitors for their commercial advantage.

Regarding question 2, I can confirm that in 2014 all drug alerts and notifications were migrated to a new government website and therefore the publication date displayed currently does not reflect the actual date of initial publication but rather the date it was published on the new website.

Regarding question 3, I can confirm the MHRA do not hold information regarding the exact type of mould present in the packaged syringes. Information surrounding what caused the mould and any associated laboratory results is also exempt under Section 41 and Section 43.

You also asked for information on:

• “All FOI Category 1b data associated with any adverse reaction report submitted to the MHRA in relation to the Rabipur rabies vaccine since 2008, in which the time lag between the administration of the first dose of the vaccine and symptoms onset is at least 120 days.”

• “All FOI Category 1b data associated with any adverse reaction report submitted to the MHRA in relation to the recalled Rabipur batches (490011C, 493011A), and additionally, batch 495011A.”

I can confirm that the MHRA has received no UK spontaneous ADR reports associated with Rabipur received between 01/01/2008 and 20/07/2022 where the onset of the suspected reactions is greater than or equal to 120 days. Please note the date the patient received a medicine or vaccine and the start date of the suspected adverse reactions are not mandatory within a Yellow Card report and are therefore not always provided by the reporter.

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.

The MHRA will not release any data subset in which there are five or fewer cases per cell as this is necessary to prevent identification of patients and/or reporters. As there are only five cases relating to the recalled Rabipur batches (490011C, 493011A) or batch 495011A, the data in these cases has been aggregated below.

Patient ages are within the range of 18-65. Three patients are female and two are male. In two of the cases Rabipur is the only suspect vaccine but in the other cases there are other suspect vaccines (Ixiaro and/or Stamaril). Dose and route of administration for Rabipur was provided in three of the cases all of which reported an intramuscular route and a 1ml dose of Rabipur. The suspected adverse drug reactions (ADRs) reported in one or more of these cases were as follows: dizziness, erythema, oropharyngeal pain, paraesthesia, petechiae, pruritis, pyrexia, rash and swelling face. In four of the five cases these suspected ADRs were all reported as recovered/resolved, in the final case the outcome was reported as recovering/resolving for all suspected ADRs. One patient had a history of hypothyroidism.

Information on the known possible side effects of the Rabipur vaccine can be found within the product information, available at https://www.medicines.org.uk/emc/product/2502.

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