Monday, October 3, 2022

Myocarditis or pericarditis after mRNA COVID-19 vaccination

Post-marketing surveillance of COVID vaccination from Pfizer and Moderna has identified a possible association between its use and subsequent episodes of myocarditis and pericarditis – two forms of inflammation of the heart. Pericarditis involves inflammation of the sac containing the heart, which acts as a buffer to the heartbeat and causes discomfort from all that motion when inflamed. Myocarditis is an inflammation of the middle layers of the heart wall, and it also causes pain and can fail the function of the heart to fully circulate our blood. Pericarditis and myocarditis are both associated with viral infections, although in many cases the underlying cause is unknown. Both are generally self-limiting problems that resolve with medical help rather than medical intervention.

the study

The research is based on Ontario, Canada’s system for reporting adverse events following COVID immunization between December 2020 and September 2021. Reporting is mandatory for health professionals and voluntary for patients or their caregivers. So we can say at the outset that the total number of adverse events is low, but probably not by an order of magnitude. Cases where the patient discontinued a torsion and did not seek care do not represent significant morbidity. Approximately 19.7 million doses of mRNA vaccines administered in the Ontario Registry and 417 cases of myocarditis or pericarditis were found.

The diagnosis of myocarditis or pericarditis may be uncertain; Very few people line up for a biopsy of their heart to provide histologic evidence. The researchers classified the indeterminateness of cases of myocarditis and pericarditis using the Brighton criterion. The Brighton Collaborative, established in 2001 long before COVID, is an international effort to define the adverse effects of vaccination. His methodology has been adopted in many countries including Canada. Brighton defined three levels of certainty associated with myocarditis and pericarditis: level 1, a definite case, with a confirmed biopsy or MRI, level 2, and level 3, a probable case, based on symptoms, an abnormal EKG, and Some biomarkers of inflammation not cardiac injury (eg, C-reactive protein). Using these definitions, the researchers identified 71% of the reported cases as having one of three levels of certainty. Out of these 297 cases:

  • 69.7% occurred after second dose of vaccine
  • 76.8% occurred in men
  • average age 24
  • Roughly a third of cases had pericarditis, a third myocarditis, or a third both.
  • The median time to onset of symptoms was within three days of vaccination, with most cases being identified within seven days.
  • The incidence of myocarditis and pericarditis was higher after the second dose, with Moderna’s vaccine and more frequently in men.
  • The group of men 18–24 following the second dose of Moderna was the group with the highest case rate of 300/1,000,000 (0.03%). Adverse reactions to Pfizer’s vaccine were low: 59/case per 1,000,000 shots (0.006%).
  • The second largest group were males aged 12–17, with a case rate of 97/1,000,000 (0.01%).
  • Essentially all of these patients were seen in ED; 70% were admitted, and 5% were in the ICU. there was no death [1]

more data = better data

Much of this has been known since the inception of large-scale vaccination programs, but recognizing that the percentage will change as the percentage, the number of cases, and denominator, the number of vaccinated individuals change – it It’s just math. More importantly, being patient enough to wait longer, more defined, “better” information can be helpful.

Myocarditis or pericarditis after mRNA COVID-19 vaccinationThe incidence of myocarditis and pericarditis decreased as the interval between vaccine doses increased. Combining the doses given, one Modern and one Pfizer’s, a heterogeneous schedule also resulted in low case rates for these adverse effects.

These results are consistent with the results observed in the US. But here’s where our friends of the North differed: Instead of withholding vaccination or inciting politically motivated anger, they opted to change their perspective on changing evidence. They began offering the Pfizer vaccine preferably to younger men at higher risk and issued guidelines that recommended longer intervals between doses.

Comparing the adverse effects of the vaccine with Kovid itself

Finally, to give some context to all these numbers, consider a study conducted on patients hospitalized with COVID in the US during the same period. [2]

  • Incidence of myocarditis in hospitalized patients, if they COVID was not (control group), was 0.009% – slightly higher and 3 times the case rate in the highest immunized group receiving the Pfizer vaccine low compared to those receiving the Moderna vaccine.
  • Incidence of myocarditis in hospitalized patients with covid was 24% for the same age groups
  • This month, 18-29 year olds represent 16% of all COVID cases.

getting it right

Clearly, in the midst of an looming pandemic, we’ve got things going wrong. It makes little sense that we would attribute these errors to malafide intention. I’m not suggesting that we don’t act on the information we have, but we are a little more modest in presenting and refuting those conclusions as the data evolves. As with any other drug or therapy, adverse effects will inevitably be present. But it is important to consider the benefits as well as the effects of treatment. Failure to do so may only provide the public with skewed and inaccurate information, which is what we need during a pandemic. Final words for the researchers,

“Importantly, the risk of myocarditis or pericarditis after receipt of mRNA vaccines is also considered in relation to the risks of myocarditis following SARS-CoV-2 infection (ie, higher rates of myocarditis after infection than after vaccination). and its high effectiveness mRNA vaccine product. … These results would also be helpful in the ongoing context of the risk of myocarditis or pericarditis after receiving mRNA vaccines compared to the risk of SARS-CoV-2 infection and related outcomes.”

[1] Remember that these patients sought and received therapy and may reflect an overestimate of severity. The percentage has been rounded up.

[2] Selecting re-hospitalized patients underestimated the impact of myocarditis, but this is a relatively apples-to-apples comparison because the same criteria were used in the Canadian study.

Source: myocarditis or pericarditis mRNA after COVID-19 vaccination JAMA Network Open DOI: 10.1001/jamanetworkopen.2022.18505

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Nation World News Desk
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