FOI release

Freedom of Information request (FOI 22/1067)

Published 17 January 2024

22nd November 2022

FOI 22/1067

Dear

Thank you for your recent FOI request dated 27th October 2022, where you asked the following:

• the patient-level data underpinning the claims made by the RCOG in the documents the DofH are referring to in their email below (dated 23rd September 2022). It seems that K Chukwuadinula (Ministerial Correspondence and Public Enquiries Department of Health and Social Care) is unable to supply the data directly underpinning his claims.

As you will know, we publish a summary of Yellow Card reports which have been reported in association with COVID-19 vaccines. Here you can see from the Vaccine Analysis Prints (VAPs) the types of reactions that have been reported to each of the COVID-19 vaccines and details of safety issues which have been reviewed: Coronavirus vaccine - summary of Yellow Card reporting - GOV.UK (www.gov.uk). There is also a section specifically regarding the safety of COVID-19 vaccines in pregnancy and breastfeeding with links to various studies which you may find helpful. The evidence currently indicates that COVID-19 vaccines are safe in pregnancy and there is no current evidence that COVID-19 vaccination causes any harm to breastfed children or affects the ability to breastfeed. Further to your request of data underpinning the Q&As released by the RCOG, please contact the RCOG specifically at, [Contact us

RCOG](https://www.rcog.org.uk/contact-us)

With regards to Yellow Card data specifically, patient level data is exempt from disclosure under Section 40 (personal information) and Section 41 (information provided in confidence) of the Freedom of Information Act which is further explained below.

Use of Section 40 (personal information)

Our rationale for using Section 40, which is an absolute exemption, is as follows. As part of our proactive vigilance surrounding the COVID-19 vaccines, the MHRA collects reports of suspected side effects via the Yellow Card scheme. The Yellow Card scheme underpins medicines and vaccines safety monitoring in the UK. Through this scheme, members of the public and healthcare professionals voluntarily submit reports of suspected side effects to the MHRA. The key strength of the Yellow Card scheme is that it allows any member of the public or health professional across the UK to immediately alert us to any concerns they have without a formal diagnosis. As such, Yellow Card reports are constantly reviewed and may contribute to the identification of a potential safety signal.

The Agency first considered whether the information requested was personal data i.e. if the person is identifiable from the data, either by itself or with other data. Our lawful basis for processing personal data is General Data Protection Regulation (GDPR) Article 6(1)(e), which allows us to process personal data when this is necessary to perform our public tasks as a regulator.

Yellow Card reports require the collection of some information about the individual affected. If a patient is submitting a report about themself, the information will relate to them and include some special category personal data, such as information about their health. The lawful bases we rely on to process special category personal data are Article 9(2)(i) of the GDPR and Schedule 1 part 1(3) of the DPA, both of which enable us to process such information when it is necessary for reasons of the public interest in the area of public health.

Where we share Yellow Card data for scientific or public health research purposes, we rely on GDPR Article 9(2)(j) as our lawful basis for processing special category personal data and Schedule 1 part 1(4) of the DPA. These bases permit us to process personal data for these purposes where it is in the public interest, subject to appropriate safeguards to protect the reporter/patient’s rights and freedoms.

Use of Section 41 (information provided in confidence):

Regarding Section 41, as outlined in our [Privacy Policy Privacy Policy

Making medicines and medical devices safer (mhra.gov.uk)](https://yellowcard.mhra.gov.uk/privacy-policy/), the MHRA will not share the identity of anyone submitting a Yellow Card report with any person outside the MHRA without their explicit consent, unless we are required or permitted to do so by law. The Policy also states that we may receive requests for Yellow Card report data under the Freedom of Information Act. While we are legally obliged to provide some of the requested information, we only provide high-level summary information with all person-identifiable data excluded.

We hope you understand, 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