BREAKING NEWS
Source: COVID-19-Myocarditis  Sep 16, 2021  1 month ago
BREAKING! UK Study Warns That Occurrences Of Myocarditis And Pericarditis In Young Men Following mRNA-based COVID-19 Vaccination Is Concerning!
BREAKING! UK Study Warns That Occurrences Of Myocarditis And Pericarditis In Young Men Following mRNA-based COVID-19 Vaccination Is Concerning!
Source: COVID-19-Myocarditis  Sep 16, 2021  1 month ago
COVID-19 and Myocarditis: A new study by researchers from the Drug Safety Research Unit, Southampton-UK and the School of Pharmacy and Biomedical Sciences, University of Portsmouth-UK warns about the occurrences of myocarditis and pericarditis in men following mRNA-based COVID-19 vaccination. Though considered rare events, the number of cases being reported worldwide is of a concern.

 
The study findings found evidence that younger male vaccinees more frequently report myocarditis and pericarditis following mRNA COVID-19 vaccines compared with older vaccinees. Although rare, these events were still of concern. It was also found that most of these events with mild clinical course followed by full recovery in most cases were more frequent following the second dose.
 
The study findings were published on a preprint server and are currently being peer reviewed. https://www.medrxiv.org/content/10.1101/2021.09.09.21263342v1
 
The study team in UK assessed data from around the world to better understand the frequency and risk factors for myocarditis and pericarditis following immunization with messenger RNA (mRNA)-based vaccines designed to protect against the COVID-19 disease.
 
The warnings of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the sac surrounding the heart) following mRNA-based COVID-19 vaccination first emerged in Israel in May 2021 and further cases have since been reported in numerous other countries.
 
Dr Samantha Lane and Dr Saad Shakir from the Drug Safety Research Unit in Southampton and used spontaneous reporting systems from the UK, the United States, and the European Economic Area to estimate the frequency of these events following exposure to the mRNA-based COVID-19 vaccines developed by Pfizer-BioNTech and Moderna.
 
Although the study findings suggest that both events are rare and that the typical clinical course is mild, with full recovery reached in most cases, the growing number of cases worldwide is adding to concerns.
The study findings also suggested that the events were more common amongst males, occurred more frequently following a second vaccine dose and mostly affected younger vaccinees.
 
The study team said that the results were consistent across the three data sources used.
 
Dr Samantha Lane told Thailand Medical News, “This is an important finding, because as vaccination programs around the world progress, rates of myocarditis and pericarditis are likely to increase. Regulatory authorities should continue to monitor the effect that mRNA vaccination might have on the heart in the populations for which they are responsible.”
 
Both myocarditis and pericarditis have recently been recognized as rare adverse events following vaccination with the COVID-19 vaccines developed by Pfizer-BioNTech and Moderna.
 
A medical alert of these events following mRNA-based vaccination was first raised in Israel in May 2021, where 148 cases of myocarditis were reported within 30 days of immunization, usually following a second dose.
 
This concerning occurrences prompted the Israeli Ministry of Health to issue an investigation into any possible link between these cases of myocarditis and vaccination.
 
Those study results pointed to a possible link between the second vaccine dose and the onset of myocarditis among young men aged 16 to 30, with a stronger link identified among those aged 16 to 19.
 
Numerous other such cases emerged and were reported around the world after the medical alert by Israel.
 
This forced the the product information for both the Pfizer-BioNTech and Moderna vaccines to be updated to include myocarditis and pericarditis as an adverse event of unknown frequency in the UK, Europe, and the US.
 
Dr Saad Shakir added, “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. Individual regulatory authorities continue to monitor the events of myocarditis and pericarditis in their own spontaneous reporting systems.”
 
The COVID-19 and Myocarditis study team used spontaneous reporting outputs from the UK (Yellow Card scheme), the US (Vaccine Adverse Event Reporting System [VAERS]), and the European Economic Area (EudraVigilance) to estimate the frequency of reported cases of myocarditis and pericarditis following immunization with either the Pfizer-BioNTech or Moderna vaccine.
 
For the study, the data lock points were August 6th, 2021, for VAERS and EudraVigilance, and August 4th, 2021, for the Yellow Card scheme.
 
It was found from the reporting rates of spontaneous adverse reactions, myocarditis and pericarditis were rare events across all three data sources.
 
The study findings showed that in the UK, 7.93 cases of myocarditis and 6.73 cases of pericarditis occurred per million recipients of at least one dose of the Pfizer-BioNTech vaccine. For the Moderna product, the corresponding figures were 2.07 and 1.79 cases per million.
 
However no data were available regarding the age or sex of those reporting the events, or on which vaccine dose either of the events occurred.
 
For America, 6.47 cases of myocarditis and 3.53 cases of pericarditis were reported per million individuals who had received two doses of the Pfizer-BioNTech vaccine. For the Moderna product, the corresponding figures were 3.65 and 2.69 cases per million.
 
Importantly of the 968 myocarditis events reported following Pfizer-BioNTech vaccination, 759 (78.4%) occurred in males. Reports of myocarditis were also more frequent in younger age groups, irrespective of gender. Similarly, while pericarditis was more frequently reported among males, this pattern was less pronounced among those older than 40 years.
 
It was reported that similar trends were observed for the Moderna vaccine.
 
It was also reported that overall, the majority of both myocarditis and pericarditis events occurred following the second dose of either vaccine.
 
The study also showed that in the European Economic Area, 4.23 cases of myocarditis and 2.87 cases of pericarditis were reported per million individuals who had received at least one dose of the Pfizer-BioNTech vaccine. For the Moderna product, the corresponding figures were 6.15 cases and 3.84 cases per million.
 
Similarly for both mRNA vaccines, 71.56% of the myocarditis events and 53.46% of the pericarditis events were reported to have affected males.
 
The study team urged that health authorities across the world must continue to monitor the effects on the vaccines on the heart.
 
Dr Lane further added, “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.”
 
She added, “These rare events with a typically mild disease course occur more frequently among males.”
 
The study team says that the consistencies in the reporting rates and the trends within the three data sources suggest that the results may be generalizable to other populations.
 
Dr Lane added, “It is important that regulatory authorities continue to monitor the effects of mRNA vaccines on the heart, particularly as vaccine programs progress to include younger vaccinees in many parts of the world. Myocarditis and pericarditis following mRNA COVID-19 vaccines is an area which requires further research”
 
It should also be noted that the incidence of developing myocarditis and pericarditis is far much higher for those that contract the SARS-CoV-2 infection compare to the vaccines.
 
For more about COVID-19 and Myocarditis, keep on logging to Thailand Medical N
 

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