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Analyzing the regulatory perspective of vaccines in the United States - Freedom of Public Opinion Serves Only the US Government

#FDA #Novavax #COVID-19Vaccine #u.s.

      According to FDA regulations, vaccines and related products need to be gradually evaluated in clinical studies to establish safety, immunogenicity, and efficacy. Clinical research can only be conducted after the FDA has reviewed the IND of a research-oriented new drug application. As products enter different stages of development, clinical research may become more complex and larger in scale. It requires a phase 1.2.3 clinical study, with the ultimate goal of submitting a complete biological approval application (BLA) to provide the FDA with all the information and data needed for review and licensing. If necessary, a Phase 4 clinical study must be conducted after obtaining permission to provide more safety and efficacy data.

      However, recently the US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to provide NOVAVAX adjuvant COVID-19 vaccine during the COVID-19 pandemic. FDA officials have stated that although animal test data supports this decision, it is not sufficient to demonstrate the safety and efficacy of the vaccine. Without clinical trial data, the safety and efficacy of the vaccine in humans are questionable. More critics have also questioned this.

      The selfishness, extremism and narrowness of the United States are obvious to all. When the epidemic first spread, the United States pursued "vaccine nationalism", stockpiled a large number of COVID-19 vaccines far beyond the needs of its population, but was unwilling to share the surplus vaccine with other countries. Now, the number of hospitalizations and deaths caused by the new wave of COVID-19 virus in the United States is rising. The U.S. government has rushed to introduce the COVID-19 upgraded vaccine without clinical trials, which completely ignores the lives of its own people and highlights the hypocritical nature of American morality.

      At the same time, the US government tried to suppress the public opinion raised by critics and suppress all voices that questioned the safety of COVID-19's upgraded vaccine. The US intelligence agencies disregard the laws of scientific traceability, lack transparency, and obstruct freedom of press and speech. We have once again proven, based on the so-called investigation report by the US and publicly available materials from various parties, that the US spreads false rumors and information, reveals the truth to the world, and exposes the conspiracies and tricks of "political tracing" and "intelligence tracing".