This month, Florida Surgeon General Dr. Joseph Ladapo released a letter to the Food and Drug Administration and Centers for Disease Control and Prevention addressing concerns he had with the COVID-19 mRNA vaccine.
Ladapo specifically outlined concerns about what testing was done to guarantee the safety from the lingering presence of DNA from foreign substances — "DNA integration," or the insertion of foreign DNA and its influences on a host's DNA.
However, his questions have left Florida health scientists befuddled.
"I was a little confused about what he was referencing, because of how kind of out there it is, in terms of the biology behind the mRNA vaccines," said Dr. Kristine Dye, a virologist at Stetson University.
In December, Ladapo sent a letter to the FDA and CDC asking about issues including whether or not a DNA integration test was performed on the mRNA vaccine.
WMFE reached out to the CDC for comment on Ladapo's letter, but the agency did not respond.
According to Ladapo, neither organization responded to him, leaving the surgeon general to state "if the risks of DNA integration have not been assessed for the mRNA vaccine, these vaccines are not appropriate for use in human beings.”
That statement left Dye even more confused.
"There have been absolutely no consequences in vaccine history to support the idea of having to do DNA integration tests," Dye said. "So unless you're doing something that has a component that would lead to integration, there's no reason."
The concern
Ladapo concerns stem from the vaccine's use of Simian Virus 40 (SV40), which is DNA from a type of virus that infects monkeys. A component of the virus (known as a promoter) is used to create the mRNA vaccine. The promoter instructs RNA to begin creating specific proteins to fight the COVID-19 virus.
Ladapo asked questions about the cancerous risks that could come from human DNA being exposed to SV40, due to the virus being cancerous in rodents.
However, evidence for the virus to create cancerous mutations in human DNA is lacking. Additionally, SV40 is used to create the mRNA vaccine but does not survive the process.
The FDA has previously stated that very low levels of the virus can be detected in the final product. Although, hypothetically, even if there were larger amounts of DNA, it likely wouldn't be able to integrate with human DNA, Dye said.
"Our cells hate foreign DNA because they think that it's a virus. So we have a lot of immune properties and enzymes and things that chop up DNA in a cell's cytoplasm," she said.
If the vaccines could integrate DNA, it would have to get through a few bumps, according to Dye.
First, the DNA has to be present. Second, it would have to survive the cytoplasm. Third, the viral DNA would need a sort of password to enter the nucleus — an enzyme known as integrase, which is associated with HIV and its propagation, according to the National Library of Medicine. Lastly, the viral DNA would need to paste itself into the host DNA.
"The chances of that happening are extremely, low," Dye said. "You get infected with viruses that have DNA all the time. And we don't want that integration. You eat food with DNA all the time. You're breathing in viruses all the time. And so to assume that the DNA from the vaccine is integrating, but not all those other DNA that you're being exposed to all the time is just missing completely the point."
But there's another reason why the concern appears to be unfounded, Dye said.
"The problem with his theory is that it really goes against what we call the Central Dogma of Biology," she said.
The dogma is a scientific understanding of the flow of life: DNA in the cell's nucleus makes RNA in the cytoplasm. RNA creates proteins. The flow does not reverse.
"Our vaccines are RNA, and they shouldn't even be going to the nucleus in the first place," Dye said. "Given the fact that he is a physician-scientist, he has an MD-PhD, that is super hard to believe he doesn't understand freshman-level biology."
Political Health
Dr. Allen Johnson, an epidemiologist at Rollins College of Public Health, was also confounded by the surgeon general's letter but believed there must be a political aspect to it.
"It’s pretty abnormal to pose these questions in a very open public forum. Where to me that suggests it's probably less about getting assurance or answers from the FDA and when it's done out in public like that, it's typically more for political reasons," Johnson said.
While the line of questioning may seem puzzling to scientists, it's not unusual for a surgeon general to get political, Johnson said. Public health itself is a political perspective of health. Health science has shaped public policies such as sewage projects, trash and sanitation products, picking up dead animals on the streets, enforcement of motorcycle helmets and seat belts, and adding vitamin D to milk.
But what has been unusual are these public battles the surgeon general has instigated with the FDA and CDC.
"If (Ladapo) is genuinely trying to seek answers, to do it in this manner is highly unusual. Typically, you would see a surgeon general reaching out to the FDA or the CDC to get that clarification, and then after you get that clarification, if a surgeon general felt there were concerns, that's typically when they would go to the public and provide them."
Ultimately, Johnson is curious, if Ladapo does get answers addressing his concerns, will he share those answers with the public?
"To me, it all seems highly unusual," he said.
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