FDA is still using emergency use authorization to release COVID-19 shots without meeting safety standards How did they get away with it this time around?
When the latest vaccines were announced, the director of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, claimed in a statement: “These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality.” He conveniently forgot to mention that the standards remain way lower than usual thanks to their ongoing manipulation of emergency use authorization powers.
Much like the first COVID-19 vaccines, they took advantage of the “emergency use authorization” power that enables them to use a lower level of evidence than the traditional threshold for proving effectiveness in FDA product approvals.
The new fall vaccines target Omicron descendants, a subtype known as KP.2, even though the KP.3.1.1 variant is spreading at the moment, accounting for 37% of cases in mid-August.
“Until the FDA stops approving new Covid vaccines under the EUA, and analyzes and reports the safety and efficacy of Covid mRNA vaccines based on established standards, there will remain a cloud of uncertainty about taking these medicines,” he wrote.
After all, even the CDC and the World Health Organization have conceded that the virus is no longer a public health emergency -- more than a year ago.
FDA is encouraging all Americans to get the latest shots despite declining hospitalizations and deaths In August, it was announced that Pfizer and Moderna would be shipping millions of doses of the updated vaccines, with Novavax releasing a modified version of its own vaccine shortly thereafter.
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