FOI release

Freedom of Information request on adverse reactions following the COVID-19 vaccinations (FOI 21/878)

Published 20 January 2022

3rd September 2021

FOI 21/878

Dear

Thank you for your FOI request dated 5th August 2021, where you requested the following information:

• COVID-19 vaccine adverse reactions and deaths for Buckinghamshire Area Health Authority as well as Bracknell Forest, West Berkshire, Reading, Slough, Windsor and Maidenhead and Wokingham.

All of the data provided below relates to UK spontaneous suspected Adverse Drug Reaction (ADR) reports concerning COVID-19 vaccines received directly by the MHRA (not via pharmaceutical companies). Data provided includes COVID-19 vaccine ADR reports from the geographical area covered by the NHS Buckinghamshire Clinical Commissioning Group (CCG) up to and including 26/08/2021. The data provided also includes COVID-19 vaccine ADR reports from NHS East Berkshire CCG and NHS Berkshire West CCG, which cover the additional areas requested. Please note that the accuracy of the data relies on the postcode being provided by the reporter. Where reporters have only provided an email address and not a postal address these reports will not be included in the numbers provided below.

Table 1: Direct UK spontaneous suspected ADR reports for COVID-19 vaccines received from NHS Buckinghamshire CCG, NHS East Berkshire CCG and NHS Berkshire West CCG up to and including 26/08/2021.

COVID-19 vaccine	Number of Yellow Card Reports	Number of Yellow Card Reports with a Fatal Outcome
Astrazeneca	6220	20
Moderna	956	0
Pfizer/ BioNTech	2219	11
Brand Unspecified	17	0

With regards to your comments on pregnancy, it should be noted that the data cited from the New England Journal of Medicine (NEJM) article (Shimabukuro et al) refers to 104 spontaneous abortions from 829 completed pregnancies of whom with 129 received the vaccine before the 3rd trimester. However, it is not correct to calculate the rate of spontaneous abortions from this as it does not include the numbers of pregnancies that were still ongoing. Instead the rates of spontaneous abortion should be calculated from the numbers of women vaccinated early in pregnancy (as only these women would still be at risk of a pregnancy loss before 20 weeks) and not from the numbers of completed pregnancies. Table 3 in the NEMJ article gives the numbers of participants in the registry by timing of the first eligible dose. This includes 92 women within 30 days before their last menstrual period and 1132 women who received the vaccine in their first trimester. Using the latter, this would give 104 spontaneous abortions from 1132 of women who received in their first trimester (9.2%) or 8.5% if those who received the vaccine in the month before are also included. Both of these are below the cited national average of 10-26% spontaneous abortions of all pregnancies.

With regards to your comments on myocarditis and pericarditis (heart inflammation), please note that myocarditis and pericarditis happen very rarely in the general population, and it is estimated that in the UK there are about 6 new cases of myocarditis per 100,000 patients per year and about 10 new cases of pericarditis per 100,000 patients per year.

The MHRA has undertaken a thorough review of both UK and international reports of myocarditis and pericarditis following vaccination against COVID-19. There has been a recent increase in reporting of these events in particular with the Pfizer/BioNTech and Moderna vaccines, with a consistent pattern of cases occurring more frequently in young males and shortly after the second dose of the vaccines. These reports are extremely rare, and the events are typically mild with individuals usually recovering within a short time with standard treatment and rest. People should come forward for their first and second vaccination when invited to do so, unless advised otherwise.

These reports have also been analysed by the Government’s independent advisory body, the Commission on Human Medicines (CHM) and its COVID-19 Vaccines Benefit Risk Expert Working Group. Following their advice, the product information for the Moderna and Pfizer/BioNTech vaccines have been updated to inform of these cases and advise healthcare professionals and patients to be aware of important symptoms for myocarditis and pericarditis.

The MHRA will continue to closely monitor cases of myocarditis and pericarditis with all of the currently authorised COVID-19 vaccines. It is important that anyone who experiences new onset of symptoms such as chest pain, shortness of breath or feelings of having a fast-beating, fluttering, or pounding heart seeks medical attention.

As you already know, we publish a weekly summary of Yellow Card reporting including information regarding myocarditis and pericarditis, and the safety of COVID-19 vaccines in pregnancy. The latest report can be found here: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting

We have in place a proactive strategy to monitor the safety of the COVID-19 vaccines, and through this strategy we are able to rapidly detect, confirm, and quantify any new risks and weigh these against the expected benefits. We can then take any necessary action to minimise risks to individuals. We also work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects. Part of our monitoring role includes reviewing reports (Yellow Cards) of suspected side effects.

I hope that you will find this information useful.

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