Request

‘(2) the summary of MHRA's regulatory position on all Covid-19 vaccines and HLH, February 2024, and the review of 8 August (if different in any respect), referred to in paragraph 46 of the reassessment report; and’

Our response

I can confirm that the NHSBSA holds the information you have requested. Attached is a copy of the summary of the Medicines and Healthcare products Regulatory Agency’s (MHRA) regulatory position for haemophagocytic lymphohistiocytosis (HLH) reported following COVID-19 vaccines which MHRA provided the NHSBSA in February 2024.

A review of the regulatory position was carried out by MHRA on 8 August 2024 where they confirmed there was no changes to their regulatory position. This review is also contained in the attached document.

Each claim is assessed on a case-by-basis by a medical assessor. All medical assessors are General Medical Council (GMC) registered doctors with a license to practise and at least 5 years' experience.

The medical assessors will consider clinical research, epidemiological evidence, and the current consensus of expert medical opinion together with a claimant’s application and their medical records from their healthcare providers to make a clinical assessment on whether the claim meets the criteria for a Vaccine Damage Payment. Medical assessors use resources to support their assessment, including, but not limited to, some or all of the following:

• Vaccine Damage Payment Scheme - Principles of Medical Assessment Guidance (PDF: 418KB).
• Medicines and Healthcare products Regulatory Agency (MHRA) data, including Yellow Card information on suspected safety concerns involving a healthcare product.
• Vaccine product information and updates.
• The Green Book - a reference material produced by the UK Health Security Agency and used by healthcare professionals in the UK. The Green Book brings together all documents relating to immunisation against infectious diseases. Visit Immunisation against infectious disease: the green book front cover and contents page - GOV.UK for more details.
• Detailed guidance on disablement assessments relating to Schedule 2 of The Social Security (General Benefit) Regulations 1982 (legislation.gov.uk), which have been developed by the Department of Work and Pensions (DWP).
• World Health Organization (WHO) documents.
• Established and accepted medical epidemiological research papers.
• Past tribunal decisions and case law.

These resources are available at:

https://www.nhsbsa.nhs.uk/vaccine-damage-payment-scheme-vdps-claim-process

The medical assessor will advise if the applicant is entitled to a Vaccine Damage Payment, based on the government’s rules for the scheme.

Data Queries

Please contact foirequests@nhsbsa.nhs.uk ensuring you quote the above reference if you have any specific questions regarding this response; or, if you feel you may be misunderstanding or misinterpreting the information; or, if you plan on publishing the data.

Reusing the data and copyright

If you plan on producing a press or broadcast story based upon the data please contact communicationsteam@nhsbsa.nhs.uk. This is important to ensure that the figures are not misunderstood or misrepresented.

The information supplied to you continues to be protected by the Copyright, Designs and Patents Act 1988 and is subject to NHSBSA copyright. This information is licenced under the terms of the Open Government Licence detailed at:

https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/

Should you wish to re-use the information you must include the following statement: “NHSBSA Copyright 2025” Failure to do so is a breach of the terms of the licence.

Information you receive which is not subject to NHSBSA Copyright continues to be protected by the copyright of the person, or organisation, from which the information originated. Please obtain their permission before reproducing any third party (non NHSBSA Copyright) information.