The FDA disagrees with Ladapo’s concerns about DNA fragments in mRNA COVID-19 vaccines, stating that over a billion doses have been administered without safety concerns.
Ladapo raised potential risks of cancer and DNA integration, but the FDA emphasized the vaccines’ safety and effectiveness.
Pfizer refuted Ladapo’s claims, affirming the safety and regulatory approval of its vaccine. (Trending: ‘American Idol’ Producer Sued For Sexual Assault)
Moderna did not comment.
“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,” an FDA spokesperson stated.
“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.”
“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,” Dr. Peter Marks, director of the Center for Biologics Evaluation and Research wrote.
“Additionally, with over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified.”
“The FDA’s response does not provide data or evidence that the DNA integration assessments they recommended themselves have been performed,” the surgeon general pressed.
“Instead, they pointed to genotoxicity studies — which are inadequate assessments for DNA integration risk. In addition, they obfuscated the difference between the SV40 promoter/enhancer and SV40 proteins, two elements that are distinct.”
“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,” Ladapo added.
“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.”
“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,” the FDA said.
“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.”
Ladapo has clashed with the FDA and CDC previously, and Pfizer emphasized the safety and global regulatory approval of its COVID-19 vaccine.
“There is no evidence to support claims that the Pfizer-BioNTech COVID-19 vaccine contains plasmid DNA that could potentially impact a person’s DNA or be a theoretical cancer risk,” a Pfizer spokesperson stated.
“SV40 stands for Simian Virus 40. It is a naturally occurring virus and the virus itself is not included in either starting materials, plasmid DNA, or in the final product of the Pfizer-BioNTech COVID-19 vaccine. However, specific, non-infectious parts of the SV40 sequence, which are commonly used in the pharmaceutical industry are present in starting material used by Pfizer and BioNTech,” they added.
“The Pfizer-BioNTech COVID-19 vaccine has been reviewed by multiple regulatory authorities, including the EMA and U.S. Food and Drug Administration (FDA), and advisory bodies globally and has met all safety and quality control guidelines. These agencies approved our COVID-19 vaccine with established specifications for development and manufacturing, including a validated method for assessment of residual DNA outlined by the World Health Organization and FDA for biological products.”
“It is important to note that similar quality standards regarding residual DNA are applied to other vaccines. Small amounts of residual DNA can be found in several approved vaccines, including influenza and hepatitis vaccines, which have been administered globally for more than 30 years.”
“Since its initial authorization for use in December 2020, the Pfizer-BioNTech COVID-19 vaccine has been administered to more than 1.5 billion people, has demonstrated a favorable safety profile in all age groups, and has helped protect against severe COVID-19 outcomes, including hospitalization and death,” they added.
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