FOI release

Freedom of Information request on the COVID-19 vaccinations and atrial fibrillation (FOI 22/396)

Published 31 May 2022

FOI 22/396

17th February 2022

Dear

COVID-19 vaccines and atrial fibrillation

Thank you for your email dated 21 January 2022 where you asked for 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 weekly report covering adverse reactions to approved COVID-19 vaccines can be found here: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions. 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 February 9th we have received 275 reports of atrial fibrillation with the COVID-19 Pfizer/BioNTech Vaccine, 354 for COVID-19 Vaccine AstraZeneca, 32 for COVID-19 Vaccine Moderna and 4 reports where the brand of COVID-19 vaccine was not specified. For context in the UK Data from the UK Public Health agencies show that at least 138,785,770 doses have been administered in the UK by 9 February 2022.

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. You may also be interested to read the COVID-19 vaccination information for public health professionals here: https://www.gov.uk/government/publications/covid-19-the-green-book-chapter-14a.

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,

Vigilance and Risk Management of Medicines Division