Florida‘s surgeon general issued a call Wednesday for healthcare providers to stop utilizing Pfizer and Moderna COVID-19 mRNA vaccines due to concerns about genetic contamination.
“Providers concerned about patient health risks associated with COVID-19 should prioritize patient access to non-mRNA COVID-19 vaccines and treatment,” said Surgeon General Joseph Ladapo in a press statement. “It is my hope that, in regard to COVID-19, the FDA will one day seriously consider its regulatory responsibility to protect human health, including the integrity of the human genome.”
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Florida public health officials and politicians have continued to be highly skeptical of mRNA vaccines, with 2024 presidential hopeful Gov. Ron DeSantis (R-FL) saying in September that Floridians will not be used as “guinea pigs for new booster shots that have not been proven to be safe or effective.”
Following a Florida Health Department meeting in November, Lapado sent a letter to the Food and Drug Administration and the Centers for Disease Control and Prevention inquiring about recent reports of foreign DNA material in Pfizer and Moderna mRNA vaccines. Ladapo said if the vaccine is “an efficient vehicle for delivery of the mRNA,” then it may be “an equally efficient vehicle for delivering contaminant DNA into human cells,” a process known as DNA integration.
FDA Director of the Center for Biologics Evaluation and Research Peter Marks responded to Lapado’s letter on Dec. 14, saying the practical risk of such an occurrence is “quite implausible,” noting that animal studies over the past decade as well as the current global surveillance data on mRNA vaccines show no genotoxicity or genomic disruption.
“The FDA’s response does not provide data or evidence that the DNA integration assessments they recommended themselves have been performed. Instead, they pointed to genotoxicity studies – which are inadequate assessments for DNA integration risk,” Ladapo said in Wednesday’s announcement. “If the risks of DNA integration have not been assessed for mRNA COVID-19 vaccines, these vaccines are not appropriate for use in human beings.”
An FDA spokesperson told the Washington Examiner that the agency “respectfully disagrees” with Ladapo’s announcement.
“With over a billion doses of the mRNA vaccines administered and following very careful review of all the available scientific evidence, the FDA has not identified safety concerns related to the sequence of, or amount of, residual DNA,” the spokesperson said.
Although theoretical concerns have been raised in the past, the spokesperson said, current data on mRNA technology “strongly supports the conclusion that the vaccines are safe and effective and have a highly favorable profile of benefit to risk.”
The surgeon general’s statement does not prohibit the use of mRNA COVID-19 vaccines in the Sunshine State, but it does encourage physicians and healthcare providers to seek non-mRNA vaccines, such as Novavax.
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COVID-19 vaccination rates with the most up-to-date product available remain low among all age brackets despite rising cases and hospitalizations from respiratory diseases, including COVID-19.
“Perpetuating references to this information about residual DNA without placing it within the context of the manufacturing process is misleading,” Marks said in his December letter. “Given the dramatic reduction in the risk of death, hospitalization and serious illness afforded by the vaccines, lower vaccine uptake is contributing to the continued death and serious illness toll of COVID-19.”
