Florida Surgeon General Joseph Ladapo, MD, PhD, has called for a halt to the administration of mRNA COVID-19 vaccines over concerns about what he calls nucleic acid contaminants, the office shared in a Jan. 3 news release. The move contradicts national guidelines from the CDC and FDA.
Dr. Ladapo recommends that instead of using the mRNA vaccines for now, physicians in the state should "prioritize patient access to non-mRNA COVID-19 vaccines and treatment."
"The FDA stands firmly behind the safety, effectiveness and manufacturing quality of the approved and authorized COVID-19 vaccines, and respectfully disagrees with the Florida Surgeon General's opinion…" a spokesperson told Becker's. "The challenge we continue to face is the ongoing proliferation of misinformation and disinformation about these vaccines, which results in vaccine hesitancy that lowers vaccine uptake. 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."
Dr. Ladapo's call to halt use of the vaccines comes after he first expressed concern over the approved Pfizer and Moderna COVID-19 mRNA vaccines in a Dec. 6 letter to the FDA and CDC. In it, he raised several questions and stated that the lipid nanoparticles in the vaccines "are an efficient vehicle for delivery of the mRNA in the COVID-19 vaccines into human cells, and may therefore be an equally efficient vehicle for delivering contaminant DNA into human cells. The presence of SV40 promoter/enhancer DNA may also pose a unique and heightened risk."
The FDA responded to his initial claims and questions in its own letter Dec. 14 asserting that Dr. Ladapo's claims were "misleading" and that "with over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified."
"We would like to make clear that based on a thorough assessment of the entire manufacturing process, FDA is confident in the quality, safety, and effectiveness of the COVID-19 vaccines," the FDA's December letter reads. "The agency's benefit risk assessment and ongoing safety surveillance demonstrate that the benefits of their use outweigh their risks."