The American Pharmaceuticals Agency (FDA) on Friday expressed concern about the risk of myocarditis linked to the Novavox Covit-19 vaccine. A meeting of experts is expected next week to decide whether to approve the solution in the United States.
The novovax vaccine is already approved in other countries, especially in Switzerland. Ahead of next week’s meeting in the United States, the FDA on Friday released a lengthy document analyzing these results, as it has done for the other three vaccines already approved in the country.
read more: Kovit: Swiss medicine has approved the novovax vaccine
According to the FDA, trials conducted before the emergence of the Omigron variant showed that the novovax vaccine was 90% effective against the symptomatic events of Govit-19. But against one case in the placebo group, six cases of myocarditis and myocarditis were found in the vaccinated group, the company pointed out.
Five cases
Five cases occurred within two weeks of vaccination. Of the 40,000 clinical trial participants, the FDA explained in its analysis that “the identification of multiple vaccine-related cases, if there is a causal link, raises concerns that the risk of myocarditis following the NVX-CoV2373 vaccine may be higher than the Messenger RNA vaccine approval period.”
After being vaccinated with Pfizer or Moderna, the risk of heart attack was actually increased, especially in adolescents and young adolescents. But during clinical trials of these vaccines, the FDA recalled that no cases have been identified so far. She worries that this risk is higher in Novavox.
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