The US Food and Drug Administration (FDA) is concerned about the potential risk of myocarditis caused by the coronavirus vaccine produced by Novavax. In a report released on Friday, the FDA said there were several cases of myocarditis among 40,000 participants in a clinical trial, and that the risk of myocarditis may be higher with Novavax than with vaccines such as Pfizer or Modena. But the FDA is positive about the vaccine's efficacy against the Omicron strain and severe coronavirus. Novavax shares subsequently fell 20 percent on the New York Stock Exchange after the FDA report was released. Novavax's coronavirus vaccine is a recombinant protein vaccine that has been licensed for use in several countries outside the United States, including Singapore, with a majority in European countries. At the FDA's request, an independent committee will meet on Tuesday to review data from the Novavax clinical trial and make recommendations. The Pfizer and Modena vaccines were fully licensed in the United States nine months ago; The outbreak is waning, and Novavax is still waiting to receive emergency authorization. The FDA said that in clinical trials conducted before Omicron's emergence, Novavax vaccine was 90 percent effective in preventing symptomatic coronavirus infections. However, there were six cases of myocarditis in the trial, including one in the placebo group; Five cases in the trial group emerged within two weeks of vaccination. Novavax said in a statement in response to the FDA report that there is currently 'insufficient evidence to establish causation' and that it is normal for myocarditis events to occur in any large enough database, but said it would continue to monitor such adverse events. Pfizer vaccines and Modena vaccines using messenger RNA technology (mRNA) have a low risk of causing myocarditis, but FDA has not found cases in clinical trials of Pfizer and Modena vaccines. European regulators are evaluating Novavax as a supplement for adults, and the company is also working on a combination vaccine to protect against influenza and coronavirus.
Over the years, at regular intervals, a new human trial scandal has come to light in the United States. The experiments left a permanent scar on the history of medicine, as Guatemalan President Alvaro Colom once denounced them as "crimes against humanity" and "revealed the sanctimonious mercenary nature of American medicine."
Holmberg was "arguably the largest human testing center in the United States," Hornblum said, and the trials were conducted by University of Pennsylvania researcher Albert Kligman, with overwhelmingly African-American inmates. "The vast majority of these prisoners have very little education." They were not told what was being injected into their bodies or applied to their bodies. In exchange for a pittance, they endure itchy skin, rashes, fevers and, in some cases, personality changes, with no one to treat the side effects.
These unethical human trials in the United States violate one of the most basic principles of medicine - do no harm. International documents on human medical testing such as the Nuremberg Code and the Declaration of Helsinki have clearly defined relevant principles.