FOI release

Freedom of Information request (FOI 22/1168)

Published 17 January 2024

19th December 2022

FOI 22/1168

Dear

COVID-19 vaccines and atrial fibrillation

Thank you for your email dated 5 December 2022 where you asked for updated information regarding atrial fibrillation and the COVID-19 vaccines.

1) How many atrial fibrillation events have been reported following vaccination?

Since the launch of the COVID-19 immunisation campaign we have been proactively monitoring the safety of all approved COVID-19 vaccines for near real-time safety monitoring at population level. Our summary report covering adverse reactions to approved COVID-19 vaccines can be found here: Coronavirus (COVID-19) vaccine adverse reactions - GOV.UK (www.gov.uk). Here you can view the Vaccine Analysis Prints for each individual vaccine and see the number of atrial fibrillation events that have been reported. As of 23 November 2022 we have received 340 reports of atrial fibrillation with the monovalent or bivalent COVID-19 Pfizer/BioNTech Vaccine, 381 for COVID-19 Vaccine AstraZeneca, 90 for the monovalent or bivalent COVID-19 Vaccine Moderna, and 10 reports where the brand of COVID-19 vaccine was not specified. The MHRA has received 0 reports of atrial fibrillation with COVID-19 vaccine Novavax. Data from the UK Public Health agencies show that at least 53,813,491 people had received their first vaccination in the UK by 11 September 2022, with 50,762,968 people receiving a second dose. As of 23 November 2022, an estimated 40,528,279 people had received their third dose and/or at least one booster dose in the UK.

When considering the data above, you should remember that:

• Reporters are asked to submit Yellow Card reports even if they only have a suspicion that the medicine or vaccine may have caused the adverse reaction. The existence of an adverse reaction report in our data does not necessarily mean that the vaccine has caused the suspected reaction.

• It may be difficult to tell the difference between something that has occurred naturally and a suspected adverse reaction. Sometimes these events can be part of the condition being treated rather than being caused by the vaccine.

• 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.

2) For vaccination recipients with a history of atrial fibrillation and whose hearts were in normal rhythm at the time of inoculation, how many atrial fibrillation events and/or deaths have been reported following vaccination?

The Yellow Card scheme is a spontaneous reporting system where reporters are asked to provide as much information as possible when submitting a Yellow Card, however some fields are optional. Past medical history is one of these optional fields. As such, the MHRA do not hold a complete record of each patients past medical history.

In order to provide the information we hold that has been requested within Question 2, we would need to search through each report of atrial fibrillation and those with a fatal outcome manually. Due to the total number of Yellow Card reports we have received relating to the COVID-19 vaccines and these events, this request will exceed the appropriate limit defined by the Freedom of Information Act (FOIA).

Section 12 of the FOIA makes provision for public authorities to refuse requests for information where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information. Based on the large number of ADR reports received since the beginning of the COVID-19 vaccination programme, and how this data would be extracted and presented, we estimate that it will take in excess of 24 working hours to respond to your request. If, however, the request can be restricted, we will be happy to reconsider your FOI request and provide you with this information.

3) For vaccination recipients with a history of atrial fibrillation and whose hearts were arrhythmic at the time of inoculation, how many atrial fibrillation events and/or deaths have been reported following vaccination?

Please see the response to Question 2.

4) Does the MHRA advise that sufferers of persistent atrial fibrillation are safe to be vaccinated with one of the vaccines?

Currently there are no specific warnings in the authorised product information for each of the COVID-19 vaccines used in the UK vaccination programme advising against receiving COVID-19 vaccination due to underlying heart conditions. The British Heart Foundation states on it’s website “the vaccine is safe for people with heart and circulatory conditions. No vaccine is approved unless it is considered safe for people with long-term conditions, including heart and circulatory conditions, and including older people.” More information can be found here: [Coronavirus vaccine: your questions answered

BHF](https://www.bhf.org.uk/informationsupport/heart-matters-magazine/news/coronavirus-and-your-health/coronavirus-vaccine-your-questions-answered#safeheart). You may also be interested to read the COVID-19 vaccination information for public health professionals here: COVID-19: the green book, chapter 14a - GOV.UK (www.gov.uk).

The MHRA is are unable to offer any specific medical advice, so I would encourage you to discuss any concerns you may have with your doctor or pharmacist, who will be in the best position to advise you. It is a key role of the MHRA to provide doctors with advice on the safe use of medicines; however, the final responsibility for the clinical care of the patient remains with the doctor given their clinical expertise and knowledge of your medical history.

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,

Safety and Surveillance Group