key: cord-1033285-67of2o71
authors: Lane, S.; Shakir, S.
title: Reports of myocarditis and pericarditis following mRNA COVID-19 vaccines: A review of spontaneously reported data from the UK, Europe, and the US
date: 2021-09-14
journal: nan
DOI: 10.1101/2021.09.09.21263342
sha: 15aff95a5aec53c6527efb866ab58fe54b98dcd9
doc_id: 1033285
cord_uid: 67of2o71

Background: A signal of myocarditis and pericarditis following mRNA COVID-19 vaccines first emerged in Israel in May 2021. Further cases have since been reported in multiple countries. The reporting rates of these events indicate that they are very rare given the high numbers of vaccinated persons. Males and younger vaccinees appear more frequently affected, more often following the second vaccine dose. As vaccine programmes progress with the focus shifting to younger people, it is possible that more cases of myocarditis and pericarditis will be reported. Objectives: To bring together spontaneously reported data from around the world to estimate the reporting rate in different countries and better understand the risk factors for myocarditis and pericarditis following exposure to COVID-19 mRNA vaccines. Methods: Spontaneous reports from the United Kingdom, United States, and European Economic Area were used to estimate the frequency of myocarditis and pericarditis reported following COVID-19 Vaccine Pfizer/BioNTech and COVID-19 Vaccine Moderna. Cases were stratified by age, sex, and vaccine dose where data were available. Reporting rates amongst vaccinees receiving mRNA vaccines in each region were estimated. Results: A small number of reports of myocarditis and pericarditis had been submitted to each database examined. These events are very rare according to reporting rates of spontaneous adverse reactions. The events were more frequently reported amongst males, and most reports came from vaccinees aged under 30 years. The typical clinical course of these events is mild, with full recovery in most cases. Conclusions: This study provides evidence that younger vaccinees more frequently report myocarditis and pericarditis following mRNA COVID-19 vaccines compared with older vaccinees. These very rare events with mild clinical course followed by full recovery in most cases were more frequent following the second dose. Reporting rates of myocarditis and pericarditis were consistent between the data sources.

Myocarditis and pericarditis (inflammation of the heart muscle and inflammation of the sac that surrounds the heart, respectively) have recently been recognised as very rare adverse effects of messenger RNA (mRNA) vaccines against coronavirus disease 2019 (COVID-19), manufactured by Pfizer/BioNTech and Moderna [1] [2] [3] [4] . In the general population, myocarditis is diagnosed in approximately ten to 20 individuals per 100,000 per year, and has been demonstrated as more commonly diagnosed in males and in younger age groups [5] . In the general population of the United Kingdom (UK) in 2020, the rate of myocarditis was 11.05 (9.74-12.48) cases per 100,000 person-years [6] . Symptoms indicative of myocarditis or pericarditis after COVID-19 vaccine include: new onset and persisting chest pain, shortness of breath, or palpitations following vaccination [7] . The United States' (US) Centers for Disease Control and Prevention (CDC) advise that medical attention is sought if symptom onset is within one week of receiving an mRNA vaccine [1] .

Where possible, suspected cases should be evaluated, provided guidance, and be followed up with a cardiologist [3] . It is important that differential diagnoses, including COVID-19 infection, are considered and ruled out [7] .

The signal of myocarditis and pericarditis following mRNA vaccines was first identified in Israel in May 2021, where there had been 148 cases of myocarditis reported within 30 days of vaccination, with the majority of these cases (n=121) reported after the second dose [4] . At this time, Israel had rapidly rolled out the Pfizer/BioNTech mRNA COVID-19 vaccine to its population and was amongst the first countries to provide widespread COVID-19 vaccines to young adults [4, 8] . The Israeli Ministry of Health appointed an epidemiological team to investigate the possible link between these cases of myocarditis and the vaccine [4] . Results from this assessment were that there was a possible link between the second vaccine dose and the onset of myocarditis among young men aged 16 to 30 [4] . This link was found to be stronger amongst 16-19 year olds compared with other age groups [4] .

After the signal initially emerged in Israel, further cases of myocarditis and pericarditis following mRNA COVID-19 vaccines were reported in multiple countries [7] . The World Health Organisation's (WHO) Global Advisory Committee on Vaccine Safety (GACVS) issued a statement on 9 July 2021, outlining the emerging signal of myocarditis and pericarditis [7] . On 19 July 2021, a Dear Healthcare Provider letter was issued by the European Medicines Agency, to bring clinicians' attention to this possible adverse event of vaccination [2] . Furthermore, the product information for both mRNA vaccines was updated to include myocarditis and pericarditis as an adverse event of unknown frequency in the UK, Europe, and the US [9] [10] [11] [12] [13] [14] [15] . Data suggest that the immediate course of myocarditis and pericarditis following vaccination is generally mild and responds to treatment such as rest, and nonsteroidal anti-inflammatory medications [7] . In Israel it was determined that vaccinees who develop myocarditis or pericarditis often require short-term hospitalisation [4] . Although most cases appear to have mild severity, further follow-up of cases is ongoing to determine the long term outcomes of myocarditis and pericarditis following mRNA vaccines [1, 7] .

As vaccine policies in the UK, US, and EEA progress into their advanced stages, the focus has shifted towards vaccinating adolescents and young adults, with both Pfizer and Moderna vaccines authorised for use in children over the age of 12 years in each of these regions (with the exception of COVID-19 Vaccine Moderna in the US) [10] [11] [12] [13] [14] [15] From the data available, young men and adolescent males appear at higher risk of myocarditis or pericarditis following exposure to mRNA vaccines, with cases occurring within a few days of vaccination [7] . The event appears to occur more frequently following the second dose of the vaccine. Individual regulatory authorities continue to monitor the events of myocarditis and pericarditis in their own spontaneous reporting systems [2, 3, 19] . The clinical course is typically mild and self-limiting, with most cases making a full recovery [20] . We therefore aimed to bring together spontaneously reported data from several countries to better understand risk factors for myocarditis and pericarditis following exposure to COVID-19 mRNA vaccines. This is important because young adults are or will be receiving mRNA COVID-19 vaccinations in the UK and EU. Also, only mRNA vaccines have been authorised for use in children older than 12 years. In the UK, only the first dose is planned to be administered to 16 and 17 year olds [16]; the results from this study will inform risk of myocarditis and pericarditis following mRNA vaccines in this subpopulation.

Spontaneous reporting outputs of the UK (Yellow Card scheme), US (Vaccine Adverse Event Reporting System [VAERS]), and European Economic Area ([EEA] EudraVigilance) were used to estimate the frequency of reported cases of myocarditis and pericarditis following COVID-19 Vaccine Pfizer/BioNTech (Comirnaty) and COVID-19 Vaccine Moderna (Spikevax) [21-23]. All cases of myocarditis and pericarditis which had been spontaneously reported to these systems between the date of vaccine launch and the datalock point were counted. Cases were stratified by age, sex, and vaccine dose where these data were available.

Data on events labelled "Myocarditis" and "Pericarditis" were obtained from each database. The datalock point was 6 August 2021 for VAERS and EudraVigilance, and 4 August 2021 for the Yellow Card scheme.

The number of vaccinated individuals per vaccine brand in the UK, US, and EEA were obtained from the websites of the MHRA, the CDC in the US, and the European Centre for Disease Prevention and Control (ECDC) up to the date closest to the datalock point for ADR spontaneous reports [3, 24, 25] . Reporting rates of myocarditis and pericarditis per million is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint

The copyright holder for this this version posted September 14, 2021. ; https://doi.org/10.1101/2021.09.09.21263342 doi: medRxiv preprint vaccines administered were calculated for those who had received at least one dose of each vaccine brand.

Data reported to MHRA's Yellow Card scheme was available from the data of each vaccine's approval to 4 August 2021. Overall, there were 165 reported myocarditis events and 140 pericarditis events reported to Yellow Card scheme up to and including 4 August 2021 following COVID-19 Vaccine Pfizer/BioNTech ( Table 1) . Two of these events were reported to have a fatal outcome (n=1 each for myocarditis and pericarditis). For COVID-19 Vaccine Moderna, 29 reports of myocarditis and 25 reports of pericarditis had been submitted to the Yellow Card scheme up to 4 August 2021; none of these events had a fatal outcome (Table 1) . No data was available on the age or sex of those reporting events, or on which dose of the vaccine each event occurred.

As of 4 August, it was estimated that 20.8 million first doses of the and 14.7 million second doses of the Pfizer/BioNTech vaccine had been administered in the UK [3] . Therefore, there were approximately 7.93 cases of myocarditis and 6.73 cases of pericarditis per million vaccinees who had received at least one dose of the Pfizer/BioNTech vaccine. To the same date, approximately 1.4 million first doses and 0.5 million second doses of the COVID-19 Vaccine Moderna had also been administered [3] . Therefore, of those who had received at least one dose of Moderna vaccine in the UK, 2.07 cases of myocarditis and 1.79 cases of pericarditis had been reported per million vaccinated.

To 6 August 2021, there had been 968 events of myocarditis reported following the Pfizer/BioNTech COVID-19 vaccine overall (Table 2 ). Of these, 759 (78.41%) had occurred in males (Table 2 ). There was evidence of a higher frequency of reports for younger age groups amongst both males and females ( Table 2 ). While pericarditis was again more frequently reported in males (n=391; 68.12% of 574 reported events) following the Pfizer/BioNTech vaccine, for vaccinees over 40 years of age the pattern was less pronounced ( Table 2 ). For COVID-19 Vaccine Moderna, similar trends were observed. Of the 461 events of myocarditis reported to VAERS following the vaccine, 75.70% occurred in males, with more frequent reports in younger age groups (Table 2) . Similarly, 59.36% of the total 342 reported pericarditis events occurred in males, however for pericarditis the trend in age was less distinct ( Table 2 ).

The majority of both myocarditis and pericarditis reported events occurred after the second dose of the Pfizer/BioNTech vaccine (Table 3a) and Moderna vaccine (Table 3b) . For the Pfizer/BioNTech vaccine, of the total 968 reported events of myocarditis, 586 (60.54%) were reported following the second dose while 188 (19.42%) were reported after a single dose of the vaccine (Table 3a) . Similarly, 69.41% of events of pericarditis were reported following two doses of Pfizer/BioNTech vaccine (n=320 of 461 reported events; Table 3a ). For the Moderna vaccine, 235 of 461 (50.98%) reported events of myocarditis . CC-BY-NC-ND 4.0 International license It is made available under a perpetuity.

is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint

The copyright holder for this this version posted September 14, 2021. ; https://doi.org/10.1101/2021.09.09.21263342 doi: medRxiv preprint and 173 of the 342 (50.58%) reported events of pericarditis occurred following two doses of the vaccine (Table 3b ).

In the US, there had been 90.5 million vaccinees who had received the full two-dose regimen of the Pfizer/BioNTech vaccine [24]; therefore, there were 6.47 cases of myocarditis reported per million and 3.53 cases of pericarditis per million fully vaccinated individuals. There had been 64.3 million people fully vaccinated with the Moderna COVID-19 vaccine [24]; therefore, there were 3.65 cases of myocarditis reported per million fully vaccinated Moderna vaccine recipients and 2.69 cases of pericarditis per million fully vaccinated Moderna vaccinees.

To 6 August 2021, there had been a total of 957 reports of myocarditis and 650 reports of pericarditis to EurdraVigilance from the EEA, following Pfizer/BioNTech vaccine (Comirnaty). Following COVID-19 Vaccine Moderna, there were 228 reports of myocarditis and 117 reports of pericarditis submitted to EudraVigilance up to 6 August 2021 (Table 4) . For both mRNA vaccines, 71.56% of the reported myocarditis events from the EEA were reported in males. Meanwhile, 53.46% of pericarditis events reported to EudraVigilance following mRNA vaccines were reported in males.

There were 11 reports of myocarditis and one report of pericarditis which had a fatal outcome following the Pfizer/BioNTech vaccine, and two fatal reports of myocarditis and one of pericarditis following the Moderna vaccine. Most of these fatal events were in males (nine of 15 reports with fatal outcomes overall; 60.00%). 

There have been a small number of reports of myocarditis and pericarditis following exposure to mRNA COVID-19 vaccines in each database examined, considering the number of people who have received a COVID-19 vaccine in each region. In all spontaneous reporting systems and for both mRNA vaccines, the reporting rate of myocarditis was higher than that of pericarditis. This may reflect that the diagnosis of myocarditis is relatively more straightforward. For the UK and US, reporting rates were higher for both myocarditis and pericarditis following the Pfizer/BioNTech vaccine compared with the Moderna vaccine. The opposite was observed for reports originating in the EEA for both myocarditis and pericarditis. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint When examining the demographics of vaccinees who had reported myocarditis or pericarditis following mRNA vaccines, both events appear to more commonly affect males compared with females, particularly amongst vaccinees of younger age categories (Tables  2-4 ). This is consistent with early reports surrounding these events, where it was suggested that younger males appear at higher risk of myocarditis and pericarditis following mRNA vaccines [4] . Demographic data was available for VAERS and EudraVigilance populations; in these databases results were similar with more than 70% of myocarditis and more than 50% of pericarditis events reported in males (Tables 2 and 4 ). It is possible that the event was missed or misclassification occurred in older adults, particularly in older individuals in the three populations of interest who were vaccinated prior to the signal emerging. It is also possible that some of the symptoms of myocarditis and pericarditis, e.g. chest pain and breathlessness, were attributed to other cardio-respiratory conditions in older people. Nonetheless, it is known that most cases of myocarditis (any cause) occur in young adults, with males more commonly affected than females; this supports the results observed in this study [26, 27] . Alternatively, vaccine roll out in each of the regions may have affected the results observed in some of the countries; in the UK, mRNA vaccines were more frequently used in younger age groups, while older vaccinees may have been more likely to receive an adenovirus vector vaccine.

Data on vaccine dose were only available from the VAERS database. Most cases reported to VAERS to be reported following a second dose of vaccine (Tables 3a and 3b ). This is consistent with the early signal which emerged in Israel, where 121 of the 148 reported cases of myocarditis occurred around the time of the second dose of COVID-19 vaccine [4].

Myocarditis has been observed historically following vaccination, including after smallpox, influenza, and hepatitis B vaccines; prior to COVID-19, 0.1% of reports to VAERS between 1990 and 2018 had been in relation to myopericarditis [5] . Furthermore, myocarditis is known to occur after a range of viral infections, including coronaviruses which cause Middle East Respiratory Syndrome (MERS) and COVID-19, with viral infection the most common cause of myocarditis [28] [29] [30] . This study provides evidence that younger vaccinees more frequently report myocarditis and pericarditis following mRNA COVID-19 vaccines compared with older vaccinees, and reports are more frequent following the second dose. Results were consistent between each of the three data sources used. This is an important finding, because as vaccination programmes around the world progress, rates of myocarditis and pericarditis are likely to increase. The effect of booster vaccinations with mRNA COVID-19 vaccines on the development of myocarditis and pericarditis is largely unknown. Furthermore, mRNA COVID-19 vaccines (particularly the Moderna vaccine) will be supplied to the COVAX initiative for distribution throughout lowand middle-income countries, where diagnostic imaging and access to healthcare is more difficult [31, 32] . Regulatory authorities should continue to monitor the effect of mRNA vaccination might have on the heart in the populations for which they are responsible. The proportions of young people are higher in low-and middle-income countries' populations compared to high income countries. Issuing diagnostic criteria and treatment protocols for myocarditis and pericarditis with mRNA COVID-19 vaccines that take into consideration the capabilities of the local healthcare system.

Vaccination policies in the three regions may have biased the results towards a higher numbers of adverse events reports myocarditis and pericarditis from younger vaccinees is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint

The copyright holder for this this version posted September 14, 2021. ; https://doi.org/10.1101/2021.09.09.21263342 doi: medRxiv preprint compared with older vaccinees. In each of these regions, younger people were more likely to have received mRNA vaccines, which may have contributed to higher reporting rates of myocarditis and pericarditis in younger vaccinees. The frequency of reported events per age group was presented as a crude number, and reporting rates could only be calculated as an overall estimate rather than stratified by age; based on the data available for vaccinations administered, it was not possible to determine the proportion of all vaccinees per age group who reported an event of myocarditis or pericarditis. This is very important, because it is likely that the reporting rate of myocarditis and pericarditis with mRNA COVID-19 vaccines will be higher in young people and even higher in young men if the reporting rates are stratified by age and sex. The regulatory authorities and Marketing Authorisations Holders (MAHs) need to follow up reports of these conditions with reporters to obtain as much information and make this information available publicly. Myocarditis and pericarditis following mfRNA COVID-19 vaccines is an area which requires further research.

The data sources for this study were spontaneous reporting systems of the UK, US, and EEA. All spontaneous reporting systems have well-known limitations including missing information, and reporting bias caused by publicity surrounding a particular adverse event.

[33]. Misclassification of myocarditis and pericarditis is also possible particularly before these events attracted publicity or among older age groups. Under-reporting is a major limitation of spontaneous reporting; even with the intense publicity and global attention on COVID-19 vaccine safety, it is possible that not all cases are reported to regulatory authorities [34, 35] . Furthermore, a report to spontaneous reporting systems indicates suspicion that the event was associated with the vaccine, it does not confirm that the vaccine caused the event [3, 33] . Further assessment is required to determine causality for each report. Finally, it is not possible to estimate incidence rates using spontaneous reports, and there is no unvaccinated comparison group [33].

Using publicly available data introduced some challenges, as the level of detail available was limited and varied between data sources. The MHRA does not publish detail on each of the reported events, including demographics of the vaccinees in which reported events occur. Furthermore, data on the vaccine dose on which the reported events of myocarditis and pericarditis occurred were only available for the US VAERS population. Information contained within individual reports is not routinely made available, however these comprise important clinical information that would allow better understanding of each case. Such details should be made publicly available. Better transparency is needed to allow more robust research using spontaneous reporting to be undertaken.

Pharmacoepidemiological studies are urgently needed to address many of the limitations of spontaneous reporting in understanding myocarditis and pericarditis following mRNA COVID-19 vaccines including more accurate estimates of the frequency, better understanding of the clinical course and the effects of these on quality of life. It is also important to compare the incidence and characteristics of these events with recipients of other non-mRNA COVID-19 vaccines and unvaccinated people. However, these studies will take time to be conducted. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint This study adds to existing evidence that younger vaccinees more frequently report myocarditis and pericarditis following mRNA COVID-19 vaccines compared with older vaccinees, and reports are more frequent following the second dose. These events are very rare according to the estimated reporting rates from spontaneous adverse reactions. The events were more frequently reported amongst males, and most reports came from vaccinees aged under 30 years. The clinical course of these events is typically mild, with full recovery in most cases.

The study brings together spontaneously reported adverse event data from three regions. Consistencies in the reporting rates and trends of myocarditis and pericarditis within the three data sources utilised suggest that results may be generalisable to other populations in which mRNA vaccines are used. However, limitations of the data sources used and biases which may have affected results should be considered. It is important that regulatory authorities continue to monitor the effects of mRNA vaccines on the heart, particularly as vaccine programmes progress to include younger vaccinees in many parts of the world. Myocarditis and pericarditis following m-RNA COVID-19 vaccines is an area which requires further research. Pharmacoepidemiological studies are urgently needed address many of the limitations of spontaneous reporting in understanding myocarditis and pericarditis following mRNA Covid-19 vaccines including more accurate estimates of frequency, better understanding of the clinical course and the effects on quality of life. However, they will take time to be conducted. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint

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The copyright holder for this this version posted September 14, 2021. ; https://doi.org/10.1101/2021.09.09.21263342 doi: medRxiv preprint All authors have completed the Unified Competing Interest form (available on request from the corresponding author) and declare: The Drug Safety Research Unit (DSRU) is a registered independent charity (No. 327206) associated with the University of Portsmouth. The DSRU receives donations and grants from pharmaceutical companies; however, the companies have no control over the conduct or publication of its studies. The DSRU has received grants to conduct unconditional studies on the Oxford/AstraZeneca COVID-19 vaccine and is in negotiations to receiving grants for conducting CPRD studies for Pfizer, Moderna, and Janssen COVID-19 vaccines. The DSRU has conducted benefit-risk studies on products for COVID-19, including remdesivir, lopinavir/ritonavir, chloroquine and hydroxychloroquine, and convalescent plasma. Professor Shakir is the principal investigator for an active surveillance study for the Oxford/AstraZeneca vaccine, but this assessment is unrelated to this study. Professor Shakir has been a member of Data Safety Monitoring Boards for Ipsen, Biogen, and Diurnal. None of these companies have any involvement with COVID-19 vaccines. Professor Shakir was invited by AstraZeneca to advise on the events of thrombosis with thrombocytopenia with the COVID-19 vaccine and to be a member of an advisory committee on a safety study of the Oxford/AstraZeneca vaccine in Europe. Samantha Lane has no conflicts of interest with regard to this study.

Patients and the public were not consulted during the course of this study.

SL was responsible for data acquisition, analyses, and interpretation. SL and SS were responsible for study conception, drafting and reviewing the manuscript, and approval of the final version for publication.

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