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TAMPA, Fla. (WFLA) — Florida’s Surgeon General is calling for a halt in the use of COVID-19 mRNA vaccines, going against the U.S. Food and Drug Administration’s (FDA) recommendations.
“We continue to live in a world, where the CDC and the FDA, when it comes to Covid at least, are just beating their own path and direction that is inexplicable in terms of thinking about data and thinking about common sense,” Dr. Joseph Ladapo said at a recent meeting regarding the mRNA Covid vaccine.
On Dec. 6, Ladapo sent a letter to the FDA that called into question the safety of the mRNA vaccine, citing a case study that claims the mRNA could cause cancer if a sequence of events happens. He also said there haven’t been enough clinical trials.
“DNA integration poses a unique and elevated risk to human health and to the integrity of the human genome, including the risk that DNA integrated into sperm or egg gametes could be passed onto offspring of mRNA COVID-19 vaccine recipients. 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,” Ladapo wrote in the letter. “The FDA’s response does not provide data or evidence that the DNA integration assessments they recommended themselves have been performed.”
The FDA responded with the following letter:
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 agency’s benefit-risk assessment and ongoing safety surveillance demonstrate that the benefits of their use outweigh their risks … With over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified.
FDA
“Worldwide, several billion people have gotten mRNA vaccines. To say that we don’t have the data, in fact, we do have the data,” said Dr. Thomas Unnasch with the USF Center for Global Health Research.
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Unnasch worries Ladapo’s stance could be dangerous.
“There are going to be more people who aren’t going to get vaccinated and as a result, particularly among the at-risk groups, people who don’t get vaccinated, and then there are going to be people who are going to end up hospitalized and die from the infection,” Unnasch said.
Ladapo would need federal approval to prevent the vaccine from being distributed in Florida, which Dr. Unnasch said is unlikely to happen at this time.
An FDA representative released the following statement to WFLA on Wednesday:
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. 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. In general, while concerns have been raised previously as theoretical issues, the available scientific evidence regarding the mRNA vaccines strongly supports the conclusion that the vaccines are safe and effective and have a highly favorable profile of benefit to risk. Additionally, it is simply a fact that millions of lives have been saved because of the COVID-19 mRNA vaccines, which most Americans undergoing vaccination have received (Two Years COVID Vaccines Prevented Millions Hospitalizations Deaths | Commonwealth Fund).
Perpetuating references to information about residual DNA in COVID-19 vaccines without placing it within the context of the manufacturing process and the known benefits of the vaccine is misleading. Please refer to FDA’s letter to Dr. Ladapo for an explanation along with references. As stated in the letter, 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.
