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National News See other National News Articles Title: FDA Authorizes New COVID-19 Vaccine Without Clinical Data Authored by Zachary Stieber via The Epoch Times The U.S. Food and Drug Administration (FDA) has authorized a new COVID- 19 vaccine from Novavax, giving Americans an alternative to shots from Moderna and Pfizer. A dose of Novavax's COVID-19 vaccine is prepared, in this file image. Joroen Jumelet/ANP/AFP via Getty Images Novavax’s protein-based vaccine will be available soon after regulators granted emergency authorization to the Maryland-based company for the product. FDA officials said that animal testing data supported the decision. “Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, said in an Aug. 30 statement. The FDA cleared vaccines from Moderna and Pfizer that are built on messenger ribonucleic acid technology (mRNA) earlier in the month. Critics say that the agency should not be making an assertion about safety and effectiveness in the absence of clinical trial data. “The assertion rings hollow when FDA has not required manufacturers of the mRNA biological [products] to provide scientific evidence to the public that safety and effectiveness has been demonstrated,” Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times previously via email. Novavax President and CEO John C. Jacobs said in a statement that the company’s vaccine showed “robust cross-reactivity against JN.1 lineage viruses” in animals. JN.1 was displaced in the spring by KP.3 and other variants, according to sequencing performed by the U.S. Centers for Disease Control and Prevention. The CDC estimates that KP.3 and the closely related KP.3.1.1 caused about four in 10 cases in the two weeks ending Aug. 3. The agency estimated that KP.3.1.1 became the dominant strain by the end of August. The Pfizer and Moderna vaccines target KP.3. FDA officials initially advised manufacturers to target JN.1 but later recommended they target KP.3. Because Novavax’s vaccine is built on different technology, it takes longer to manufacture than the mRNA shots. Company officials told FDA advisers over the summer that they were planning to continue manufacturing a JN.1-based vaccine and believed it would perform well against KP.3 and other strains from the JN.1 lineage. The authorization is for people aged 12 and older. People who have never received a vaccine can get two doses of Novavax’s vaccine about three weeks apart. People who have received a vaccine before can get a single dose. The Moderna and Pfizer vaccines are available for individuals who are at least 6 months old. The CDC is recommending vaccination for all people aged 6 months and older. The United States ended the COVID-19 public health emergency in 2023 but extended the emergency declaration under the Public Readiness and Emergency Preparedness Act until the end of 2024. The FDA issued the emergency authorization under that authority. COVID-19 levels have plummeted since early 2022, although data from wastewater and other sources have indicated a recent uptick. Poster Comment: "Once a government is committed to the principle of silencing the voice of opposition, it has only one way to go, and that is down the path of increasingly repressive measures, until it becomes a source of terror to all its citizens and creates a country where everyone lives in fear." -- Harry S. Truman Post Comment Private Reply Ignore Thread Top • Page Up • Full Thread • Page Down • Bottom/Latest Begin Trace Mode for Comment # 1.
#1. To: Horse (#0)
Sometimes the peoples get tired of the BS, grab their torches and pitchforks for a good old fashioned lawyer hunt.
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