EU confirms causal effect between CCP Virus vaccine and cardiac inflammation

Newstarget reported on Aug. 5th that the European Union’s vaccine regulator has confirmed that the Covid-19 (CCP virus) vaccine manufactured by Novavax can cause cardiac inflammation.

The European Medicines Agency (EMA) said on Aug. 3rd that the Maryland-based pharmaceutical should list myocarditis and pericarditis as potential side effects of the CCP virus vaccine it produces. the EMA has asked Novavax to provide additional data on these side effects.

According to the agency, healthcare professionals and people who want to get the Novavax vaccine should be warned of the risks after vaccination. Pfizer and Modena’s mRNA vaccine has also been noted with risks linked to cardiac inflammation.

A month prior, the EMA had cited anaphylaxis as a side effect of the Novavax shot. In addition, U.S. regulators also flagged cardiac inflammation risks that could caused by this vaccine.

Novavax conducted trials of its sub-unit protein vaccine on nearly 30,000 patients between December 2020 and September 2021. The U.S. Food and Drug Administration (FDA) said the vaccine’s clinical trials did raise concerns about cardiac inflammation and therefore ordered Novavax to conduct a post-authorization observational studies to evaluate a potential connection between its vaccine and “adverse events of special interest,” including myocarditis and pericarditis.

In documents released on June 3rd of this year, the FDA cited four events of myocarditis that occurred during the vaccine’s clinical trials and said these events warranted attention for a causal relationship with the vaccine, similar to the association document for mRNA vaccines. Data from passive surveillance during post-authorization use in various countries also indicated a higher than expected rate of myocarditis and pericarditis associated with the vaccine.

“Further evaluation is needed to inform the risk of myocarditis and pericarditis, and their outcomes, as additional data emerge over time,” the FDA document concluded.

Analysts suggests that the admission by two major institutions in Europe and the United States that the CCP virus vaccine has caused heart-related injured to a small number of people is setting the stage for downplaying the upcoming vaccine disaster, so that people do not associate the disaster with the governments’ mandatory vaccination policies.

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Translator: Formosa Taiwan English Team

Design&editor: HBamboo(昆仑竹)

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