FDA Authorizes New COVID-19 Vaccine Without Clinical Data
- FDA Authorizes New COVID-19 Vaccine Without Clinical Data
by Zachary Stieber, https://www.theepochtimes.com/health
Novavax’s shot, which targets the JN.1 variant, has been authorized.
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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. 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.
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“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 (mRNA) technology earlier in the month.
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Critics say that the agency should not be making an assertion about safety and effectiveness in the absence of clinical trial data.
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