According to a recent study, more cases of heart inflammation than expected have been seen in people who received the COVID-19 vaccination from Novavax.
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According to Spanish researchers, 61 incidences of myocarditis, pericarditis, or both after receiving a Novavax vaccination were documented in the World Health Organization’s vaccine safety database up through August 23, 2022.
The researchers determined that the number of post-vaccination cases was larger than anticipated using pre-pandemic rates of cardiac inflammation in the general population.
Providing odds ratios greater than one indicates a higher rate than anticipated. The ratio was 5.2 for myocarditis following the Novavax vaccination. The figure for pericarditis was 24.75. It was 14.4 for myopericarditis, or both conditions at once.
The Pfizer and Moderna COVID-19 vaccines, which use messenger RNA (mRNA) technology, are known to cause heart inflammation as a side effect; however, no information has been gathered on the condition after immunization with the Novavax vaccine, which does not contain mRNA.
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The U.S. Food and Drug Administration highlighted in fact sheets that clinical trials show there are elevated risks of myocarditis and pericarditis after receiving the Novavax vaccine when it authorized the shot during the summer of 2022. Five incidences of one or both symptoms were documented in the trial data that was submitted to the regulator in comparison to 0 cases in the placebo group. Since then, the American government has approved a Novavax booster, and most recently, a deal was negotiated to receive up to 1.5 million extra doses on top of that.
Although the European Medicines Agency eventually added a warning to its product material, it initially did not warn about inflammation following the Novavax immunization.
According to the new study, 50 occurrences of myocarditis, pericarditis, or myopericarditis following Novavax immunization have been documented in Australia. In contrast to the United States, where there have been two reports, Europe has had nine. Most of them have come from the 18 to 44 age group.
The authors of the study noted that all of the Pfizer, Moderna, and Novavax vaccines use nanoparticles to transport a spike protein into the body, even if the precise mechanism for inducing myocarditis is yet unknown.
“More research would be needed to understand the role of nanoparticles in the potential risk of vaccine-induced myocarditis,” they said.
Healthcare practitioners should be aware that Novavax may cause myocarditis, pericarditis, or both, according to the researchers, who also found a higher-than-expected number of reports for the Pfizer and Moderna vaccines.
On February 14, the study was published in Drugs—Real World Outcomes (pdf below). It was supported by the scientific network CIBERSAM.
In 2022, Novavax said that there was “insufficient evidence to establish a causal association” between the vaccination and the inflammation based on its analysis of all of its clinical trials. In an emailed statement after being asked for comment on the new study, the company said: “Reports of myocarditis or pericarditis after Nuvaxovid vaccination are rare. While the risk of developing myocarditis or pericarditis is very low, both are important identified risks of COVID-19 vaccines, including Nuvaxovid.”
The company’s vaccine is sold under the trade name Nuvaxovid.
The business added that reports of inflammation “have generally been minor, self-limited, and clinically compatible with the literature documenting myocarditis after mRNA COVID-19 immunization,” among other things. The Pfizer or Moderna vaccine recipients had a number of post-vaccination instances that were still open months later, and some of them resulted in fatalities.
If a person has a history of myocarditis or pericarditis, or if it develops after immunization, some doctors advise avoiding obtaining one of the vaccines.
“Development of myocarditis or pericarditis after a dose of an mRNA COVID-19 vaccine (i.e., Moderna or Pfizer-BioNTech) or Novavax COVID-19 Vaccine is a precaution to a subsequent dose of any COVID-19 vaccine and subsequent doses should generally be avoided,” the U.S. Centers for Disease Control and Prevention states on its website.
Myocarditis and pericarditis patients “can receive a COVID-19 vaccine,” according to Australian officials, although they are advised to seek professional advice “about the best timing of vaccination and whether any additional precautions are recommended.”
The regulator observes that a few cases of vaccine-induced myocarditis have resulted in fatalities.
Case reports show that some persons who experienced cardiac irritation following a shot continued to receive them.
Last year, the Ministry of Health, Labor, and Welfare reported the death of a man after receiving the Novavax COVID shot, which was the first fatality associated with the Novavax vaccine in Japan.
A 26-year-old healthy boy who developed pericarditis following a second dosage of Pfizer’s vaccine was one of two cases mentioned in one publication by Australian doctors. The symptoms disappeared. He received a booster made by Novavax six months later. He had comparable symptoms, including chest pain, before having pericarditis identified.
As this was going on, a 25-year-old female patient showed up 48 hours after receiving a second dosage of Pfizer’s vaccine with chest pain and other problems. The patient, who was given a myopericarditis diagnosis, had “persistent symptoms” that necessitated several hospital visits over a five-month period.
After a time, symptoms subsided and irregularities appeared to vanish. The woman afterward received a booster dose of the Novavax vaccine. She suffered chest pain and comparable symptoms five days later. A myocarditis diagnosis was made for her.
Read the study given below: