CDC, FDA Heads Fire Back at Ladapo Letter
The heads of the FDA and CDC despatched a scathing 4-website letter to Florida’s Surgeon Classic warning him that his stance on COVID-19 vaccines is “shuffle.”
FDA Commissioner Robert Califf, MD, and CDC Director Rochelle Walensky, MD, MPH, replied to a letter despatched to them final month by Florida Surgeon Classic Joseph Ladapo, MD, PhD, traumatic them on mRNA COVID vaccine safety.
In their letter, Califf and Walensky acknowledged they wished to “correct the associated misinterpretations and misinformation regarding the records from [FDA’s] Vaccine Negative Occasion Reporting Design (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 obstacles of VAERS recordsdata, which Ladapo referenced in his letter, claiming Florida seen a 1,700% expand in VAERS reports after COVID vaccines became on hand, when put next with a 400% expand in vaccine administration over the same duration of time.
He additionally wrote that the reporting of life-threatening conditions elevated 4,400%.
Those findings are “liable to reflect a sample of elevated risk from mRNA COVID-19 vaccines,” Ladapo wrote.
Ladapo additionally referenced an earlier document — unauthored, unpublished, and non-gaze-reviewed — that he used to counsel in opposition to vaccinating males ages 18 to 39 in Florida. Ladapo had additionally advisable in opposition to vaccinating teens.
Ladapo additionally wrote that healthcare professionals “should contain the flexibility to precisely talk the dangers and advantages of a medical intervention to their sufferers with out wretchedness of retaliation by the federal government.”
Califf and Walensky replied straight to that fee of their letter: “It is incorrect to indicate that the federal government will ‘retaliate’ in opposition to any healthcare provider for communicating with their sufferers regarding the advantages and risks of a particular medical product.”
They detailed several surveillance methods besides VAERS that CDC and FDA rely on to show screen vaccine safety: CDC’s Vaccine Security Datalink, the v-stable monitoring machine, the Sentinel BEST (Biologics Effectiveness and Security) Design, and the Medical Immunization Security Evaluation Challenge, to boot to to collaborations with the Centers for Medicare & Medicaid Products and companies, the Division of Veterans Affairs, and other recount and native health departments.
These methods contain allowed the businesses to establish proper however uncommon risks from the COVID vaccines, in conjunction with Guillain-Barré syndrome, thrombosis with thrombocytopenia syndrome (TTS), and immune thrombocytopenia with the Johnson & Johnson/Janssen vaccine, to boot to myocarditis, pericarditis, and anaphylaxis with the Pfizer-BioNTech and Moderna mRNA vaccines.
Califf and Walensky wrote that Ladapo’s most up-to-date VAERS diagnosis changed into “incorrect, misleading and would possibly perchance very effectively be shuffle to the American public.”
They reminded Ladapo that VAERS reports must peaceable be completely vetted, as they label now not show causality, and that the elevated make a choice of reports is a product of emergency use authorization, since corporations are required to document certain harmful events thru VAERS.
The valuable physique of evidence that has been constructed up suggests that the advantages of COVID vaccines outweigh their risks, Califf and Walensky noted.
“Now not perfect is there no evidence of elevated risk of death following mRNA vaccines, however on hand recordsdata contain proven quite the reverse: that being up up to now on vaccinations saves lives when put next to those who did now not acquire vaccinated,” they wrote.
Califf and Walensky additionally identified that seniors in Florida are under-vaccinated, with perfect 29% having bought an up up to now bivalent vaccine when put next with the nationwide sensible of 41%.
“It is the job of public health officers around the nation to present protection to the lives of the populations they attend, in particular the inclined,” they wrote. “Fueling vaccine hesitancy undermines this effort.”
Critics like a flash took apart the diagnosis that Ladapo used to counsel in opposition to vaccinating youthful males when he printed it final fall. It had no named authors, changed into now not gaze reviewed, and changed into merely posted to the Florida Division of Effectively being’s web web site.
Just a few months later, Ladapo’s colleagues from the University of Florida additionally condemned the diagnosis, despite the indisputable reality that the college declined to match.
A spokesperson for the Florida Division of Effectively being did now not return a request for comment as of press time.
Kristina Fiore leads MedPage’s enterprise & investigative reporting physique of workers. She’s been a medical journalist for more than a decade and her work has been identified by Barlett & Steele, AHCJ, SABEW, and others. Send yarn suggestions to [email protected] Follow