FOI release

Freedom of Information request (FOI 22/881)

Published 17 January 2024

FOI 22/881

1st September 2022

Dear

Thank you of your email dated 05 August 2022, where you requested the below information:

1. I would require a breakdown of all total adverse reactions reported specified under listing PDDNOS ‘Autism Spectrum Disorder’ to be categorized into age, country and postal code area.

2. I require a copy of the adverse reactions reports under listing PDDNOS ‘Autism Spectrum Disorder’.

As you are aware, the MHRA produce and publish Vaccine Analysis Prints (VAPs) which contain a complete listing of all suspected adverse reactions that have been reported to the via the Yellow Card scheme for the COVID-19 Vaccine Pfizer/BioNTech, the COVID-19 Vaccine AstraZeneca, the COVID-19 Vaccine Moderna and where the brand of the vaccine was not specified. This includes all reports received from healthcare professionals, members of the public, and pharmaceutical companies and all reports received of autism spectrum disorder.

The information in the VAPs do not represent an overview of the proven side effects associated with the vaccines but rather any reaction reported via the Yellow Card scheme. A list of the recognised adverse effects of COVID-19 vaccines is provided in the information for healthcare professionals and the recipient information here. These can also be found on the Coronavirus Yellow Card reporting site. Conclusions on the safety and risks of the vaccines cannot be made on the data shown in the VAP alone.

When viewing the VAP you should remember that:

• A reported reaction does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have. The fact that symptoms or events occur after use of a vaccine, and are reported via the Yellow Card Scheme, does not in itself mean that they are proven to have been caused by the vaccine.
• 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. Reporting rates are influenced by the seriousness of reactions, their ease of recognition, the extent of use of a particular medicine or vaccine and may be stimulated by promotion and publicity.
• It may be difficult to tell the difference between something that has occurred naturally and a suspected adverse reaction.
• Many factors have to be considered when assessing whether the vaccine has caused a reported adverse reaction. When monitoring the safety of vaccines and medicines, MHRA staff carry out careful analysis of these factors. Neither the MHRA nor international regulators have identified a potential link between the COVID-19 vaccines and autism spectrum disorder.

From the VAPs you will see that as of 27 July 2022 the MHRA has received a total of 5 reports of suspected autism spectrum disorder following administration of COVID-19 Vaccine Pfizer/BioNTech and 4 reports following administration of COVID-19 Vaccine AstraZeneca.

Your request is exempt from disclosure under Section 40 (personal information) and Section 41 (information provided in confidence) of the Freedom of Information Act. Providing you with a breakdown of all ADR reports concerning the COVID-19 vaccines and the reaction ‘Autism Spectrum Disorder’ categorised by age, country and postal code area, as well as copies of these reports could lead to patient identification.

Members of the public and healthcare professionals voluntarily submit reports of suspected side effects to the MHRA through the Yellow Card Scheme. As outlined in our 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. This is already available online in our Vaccine Analysis Prints.

The MHRA has been working proactively to encourage members of the public or health professionals across the UK to immediately alert us to any concerns they have without a formal diagnosis using the Yellow Card scheme. The information and data provided to us by these third parties are shared in confidence and, as above, are personal data. Sharing the information and data received would not reflect the commitments in MHRA’s confidentiality agreements, potential safety signals which would be of detriment both to the application of the Agency’s regulatory function and public health more widely.

As this is personal data in relation to an individuals’ health, this would be of detriment to them and may damage the engagement with the scheme.

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.

We hope that you find use of the information found within our VAPs and the information provided on the recognised side effects,

Yours sincerely,

FOI Team,

Patient Safety Monitoring Group

Safety and Surveillance