FDA responds to Ladapo letter about DNA fragments detected in mRNA COVID-19 vaccines



In response to a letter in which Florida Surgeon General Joseph Ladapo noted the detection of DNA fragments in mRNA COVID-19 vaccines, Peter Marks, director of the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research, emphasized the FDA's view that the shots are safe and effective.

"I am writing to you to address the recent discovery of host cell DNA fragments within the Pfizer and Moderna COVID-19 mRNA vaccines," Ladapo noted in his letter to FDA Commissioner Robert Califf and CDC Director Mandy Cohen.

"This raises concerns regarding the presence of nucleic acid contaminants in the approved Pfizer and Moderna COVID-19 mRNA vaccines, particularly in the presence of lipid nanoparticle complexes, and Simian Virus 40 (SV40) promoter/enhancer DNA. Lipid nanoparticles 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 of DNA integration into host cells," Ladapo wrote.

He also noted that "it is essential to human health to assess the risks of contaminant DNA integration into human DNA."

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But when responding to Ladapo, Marks conveyed the FDA's contention that the vaccines are safe and said that "misinformation and disinformation" causes "vaccine hesitancy that lowers vaccine uptake."

"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 benefitrisk assessment and ongoing safety surveillance demonstrate that the benefits of their use outweigh their risks. Additionally, with over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified," Marks wrote.

"No SV40 proteins are encoded for or are present in the vaccines. On first principle, it is quite implausible that the residual small DNA fragments located in the cytosol could find their way into the nucleus through the nuclear membrane present in intact cells and then be incorporated into chromosomal DNA," Marks wrote. "Additionally, studies have been conducted in animals using the modified mRNA and lipid nanoparticle together that constitute the vaccine, including the minute quantities of residual DNA fragments left over after DNAse treatment during manufacturing, and demonstrate no evidence for genotoxicity from the vaccine. Pharmacovigilance data in hundreds of millions of individuals also indicate no evidence indicative of genotoxicity."

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'Another Hint At The FDA's Intentions'

FDA now investigating after multiple allergic reactions to Pfizer COVID vaccine reported across US



The Food and Drug Administration said on Friday they are investigating after multiple allergic reactions were reported in people who had just received Pfizer's coronavirus vaccine.

The new development comes just days after the Pfizer vaccine began to be administered nationwide.

What did the FDA say?

Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said at a press conference that five allergic reactions occurred this week in more than one state.

The reactions were reportedly similar to those seen in the United Kingdom last week.

"We are working hand in hand with the Centers for Disease Control and Prevention, and we've actually been working closely with our United Kingdom colleagues, who of course reported the allergic reaction. I think we'll be looking at all the data we can from each of these reactions to sort out exactly what happened, and we'll also be looking to try to understand which component of the vaccine might be helping to produce them," Marks said, the Hill reported.

Marks explained that scientists were not certain what caused the allergic reactions, but pointed to polyethylene glycol as the possible "culprit." The ingredient is present in both the Pfizer and the Moderna vaccine.

What's the background?

At least two of the reactions happened at the same hospital in Juneau, Alaska.

As the New York Times reported, the reactions happened within minutes of vaccine administration:

[The first worker] experienced a rash over her face and torso, shortness of breath and an elevated heart rate. Dr. Lindy Jones, the hospital's emergency department medical director, said the worker was first given a shot of epinephrine, a standard treatment for severe allergic reactions. Her symptoms subsided but then re-emerged, and she was treated with steroids and an epinephrine drip. When doctors tried to stop the drip, her symptoms re-emerged yet again, so the woman was moved to the intensive care unit, observed throughout the night, then weaned off the drip early Wednesday morning, Dr. Jones said.
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The second worker received his shot on Wednesday and developed eye puffiness, lightheadedness and a scratchy throat 10 minutes after the injection, the hospital said in a statement. He was taken to the emergency room and treated with epinephrine, Pepcid and Benadryl, although the hospital said the reaction was not considered anaphylaxis. The worker was back to normal within an hour and released.

Still, the FDA said the vaccine is safe for most Americans who have allergies, Reuters reported.

The agency only warned those Americans who have a history of severe allergic reactions, or a history of allergic reactions to ingredients present in either vaccine, from immediately receiving the vaccine.