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 today is a result of several factors, starting with the fact that the most vulnerable people, due to age or comorbid medical conditions, have already died in the earlier waves of Covid. The immunity from the multiple prior vaccines also provides some value, as does the immunity from prior infections. Finally, beginning with the Omicron strain, the SARS-CoV-2 virus traded a higher infectivity capability with a reduced deadliness. This beneficial evolutionary path of the virus could have had a different, deadlier outcome. For that we can take no credit.
The Department of Health and Human Services should use the Covid data from the CDC to reevaluate whether a Covid public health emergency exists and consider declaring the pandemic over in the United States. After all, both the World Health Organization and the CDC determined in May 2023 that Covid was no longer a global or public health emergency, and HHS and the FDA should be leading the world in health care policy, not being over one year behind the curve.
Without the HHS emergency designation, the FDA would have the chance, as the premier world organization for evaluating the safety and efficacy of new medicines, to put their imprimatur on the Covid vaccines. Academic papers abound on both sides of the risk-benefit ratio, some showing clear benefits and some highlighting unusual risks. 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. The American people and their health care providers deserve an answer.
Dr. Rand Paul represents Kentucky in the U.S. Senate and is ranking member of the Senate Homeland Security and Governmental Affairs Committee. Dr. Steven Quay is CEO of Atossa Therapeutics, a company focused on preventing breast cancer.
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