麻豆传媒

The heads of the FDA and CDC sent a to Florida's Surgeon General warning him that his stance on COVID-19 vaccines is "harmful."

FDA Commissioner Robert Califf, MD, and CDC Director Rochelle Walensky, MD, MPH, responded to by Florida Surgeon General Joseph Ladapo, MD, PhD, challenging them on mRNA COVID vaccine safety.

In their letter, Califf and Walensky said they wanted to "correct the associated misinterpretations and misinformation about the data from [FDA's] Vaccine Adverse Event Reporting System (VAERS)" that Ladapo had cited in his letter to them, which he posted to social media on February 15.

Their response spends several paragraphs reminding Ladapo of the limitations of VAERS data, which Ladapo referenced in his letter, claiming Florida saw a 1,700% increase in VAERS reports after COVID vaccines became available, compared with a 400% increase in vaccine administration over the same time period.

He also wrote that the reporting of life-threatening conditions increased 4,400%.

Those findings are "likely to reflect a pattern of increased risk from mRNA COVID-19 vaccines," Ladapo wrote.

Ladapo also referenced an earlier report -- unauthored, unpublished, and non-peer-reviewed -- that he used to recommend against vaccinating men ages 18 to 39 in Florida. Ladapo had also recommended against vaccinating children.

Ladapo also wrote that healthcare professionals "should have the ability to accurately communicate the risks and benefits of a medical intervention to their patients without fear of retaliation by the federal government."

Califf and Walensky responded directly to that charge in their letter: "It is inaccurate to suggest that the federal government will 'retaliate' against any healthcare provider for communicating with their patients about the benefits and risks of a particular medical product."

They detailed several surveillance systems besides VAERS that CDC and FDA rely on to monitor vaccine safety: CDC's Vaccine Safety Datalink, the v-safe monitoring system, the Sentinel BEST (Biologics Effectiveness and Safety) System, and the Clinical Immunization Safety Assessment Project, in addition to collaborations with the Centers for Medicare & Medicaid Services, the Department of Veterans Affairs, and other state and local health departments.

These systems have allowed the agencies to identify real but rare risks from the COVID vaccines, including Guillain-Barré syndrome, thrombosis with thrombocytopenia syndrome (TTS), and immune thrombocytopenia with the Johnson & Johnson/Janssen vaccine, as well as myocarditis, pericarditis, and anaphylaxis with the Pfizer-BioNTech and Moderna mRNA vaccines.

Califf and Walensky wrote that Ladapo's latest VAERS analysis was "incorrect, misleading and could be harmful to the American public."

They reminded Ladapo that VAERS reports must be thoroughly vetted, as they do not prove causality, and that the increased number of reports is a product of emergency use authorization, since companies are required to report certain adverse events through VAERS.

The large body of evidence that has been built up suggests that the benefits of COVID vaccines outweigh their risks, Califf and Walensky noted.

"Not only is there no evidence of increased risk of death following mRNA vaccines, but available data have shown quite the opposite: that being up to date on vaccinations saves lives compared to individuals who did not get vaccinated," they wrote.

Califf and Walensky also pointed out that seniors in Florida are under-vaccinated, with only 29% having received an updated bivalent vaccine compared with the national average of 41%.

"It is the job of public health officials around the country to protect the lives of the populations they serve, particularly the vulnerable," they wrote. "Fueling vaccine hesitancy undermines this effort."

Critics quickly took apart the analysis that Ladapo used to recommend against vaccinating younger men when he published it last fall. It had no named authors, was not peer reviewed, and was merely to the Florida Department of Health's website.

A few months later, Ladapo's colleagues from the University of Florida also condemned the analysis, though the university declined to investigate.

A spokesperson for the Florida Department of Health did not return a request for comment as of press time.

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