FOI release

Freedom of Information request about specific vaccine lots (FOI 21/251)

Published 7 May 2021

Thank you for your email.

Please find below answers to the questions you have raised.

1.Could you please let me know if you have these batch numbers on file, all information on the vaccine would be kindly appreciated

LOT 15D801A MEN B exp 11/2017

LOT 140121A MEN B exp 10/2017

Both the above Bexsero batches 140121 and 15D801 were both released by the Norwegian Medicines Authority (NoMA) for use in the EU. The National Institute for Biological Standards and Control (UK Medicines Control Laboratory) carries out some tests for NoMA.

For the above batches NIBSC carried out some tests on the bulk materials used for the final vaccines, and also carried out a test on each of the final lots of the vaccine batches. All specifications of tests were met and results provided to NoMA.

The results of testing that are provided by NIBSC for some components are used by NoMA, along with their own testing results, to issue the batches of vaccines.

We cannot provide specific details of tests that are carried out for batch release of vaccines and blood products as they are exempt from release under Section 43 of the Freedom of Information due to it being commercially confidential information.

NIBSC can however confirm that all tests carried out on the lots in question by NIBSC passed the criteria for release.

As of 29/03/2021, the MHRA have received 61 UK spontaneous suspected ADR reports of the meningococcal group B (MenB) vaccine that include the batch number or a variation of “LOT 15D801A”. The MHRA have received no reports of the meningococcal group B (MenB) vaccine that contained the batch number “LOT 140121A”.

It is important to note that the MHRA does not require details of the suspect drug batch number for the completion of a Yellow Card therefore there may be additional ADR reports in which the patient received this batch where the batch number was not provided to the MHRA.

A Yellow Card report submission does not necessarily mean symptoms have 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.

We confirm that for Question 2 and Question 3 you will need to contact Public Health England (PHE). Please find below contact details.

Email: [email protected]

Phone: 020 7654 8000

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for an internal review. It will be carried out by a senior member of the Agency who was not involved with the original decision. Internal review requests should be submitted within two months of the date you receive this response and addressed to: [email protected].

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review.

The Information Commissioner can be contacted online: https://ico.org.uk/make-a-complaint/official-information-concerns-report/official-information-concern/

or by post:

Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire

SK9 5AF

Kind Regards

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000