The Food and Drug Administration last month announced the availability of new Covid-19 vaccines directed to the latest variants in circulation but failed to disclose that the vaccines have not been established as safe and effective. Given the ongoing controversies about prior Covid mRNA vaccines during the pandemic, the FDA should do the work to assure the American people that the well-established standards for vaccine approval are applied to these novel mRNA technologies.
The FDA could release the latest Covid shots without proving safety and efficacy because they remain under the “emergency use authorization” (EUA) category. According to the FDA, “The ‘may be effective’ standard for EUAs provides for a lower level of evidence than the ‘effectiveness’ standard that FDA uses for product approvals.” The FDA has this authority only because the secretary of health and human services determined on Feb. 4, 2020, that there was a public health emergency that involved the virus that causes Covid-19, and this determination has remained in place over four years later.
In 2020, the U.S. was in a Covid public health emergency, but are we still in September 2024?
The Centers for Disease Control and Prevention reports that as of Aug. 31, only 2.3 percent of emergency room visits were for Covid. The rate of hospitalization for Covid is only 0.005 percent and is dropping. From a peak death rate in 2021 of 26,028 Americans per week, there are only 663 “deaths involving COVID-19” in the latest weekly CDC data.
The reduced death rate
