COVID-19 vaccines have saved millions of lives, according to multiple studies. Getting the latest vaccines provides additional protection against negative outcomes from COVID-19. Serious side effects are rare, and the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration have determined that the benefits of vaccination outweigh the risks.
Nevertheless, Florida Surgeon General Dr. Joseph Ladapo issued a statement on January 3 calling for a halt to the use of mRNA COVID-19 vaccines made by Pfizer/BioNTech and Moderna.
Ladapo cited unfounded concerns that small amounts of residual DNA left in vaccines during the manufacturing process could become integrated into human DNA. “If the risk of DNA integration in mRNA COVID-19 vaccines has not been assessed, these vaccines will not be suitable for human use,” he said.
As we have written, there is no evidence that residual DNA, which is expected and present within the regulations, can become incorporated into the DNA of vaccinated people.
(For more information about residual DNA in mRNA vaccines, see the article “COVID-19 vaccines change DNA and have not been shown to cause cancer. ”)
In a Dec. 14 letter to Ladapo, FDA official Dr. Peter Marks said it was “completely unlikely” that residual DNA could find its way into the cell’s nucleus, where it would be integrated into chromosomal DNA. “I want to make clear that FDA is confident in the quality, safety, and effectiveness of the COVID-19 vaccine based on a thorough evaluation of the entire manufacturing process,” Marks wrote.
Residual DNA is present in a variety of vaccines. It would take a series of unlikely or improbable events for residual DNA in an mRNA vaccine to enter a person’s DNA and affect their health. These steps involve bypassing the body’s many defenses against DNA that appears in unusual locations.
Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, addressed the claims about residual DNA in the video, saying, “It is virtually impossible for these DNA fragments to cause any harm. They are clinically “It’s completely harmless,” he told Medpage Today, referring to Dr. Ladapo’s recent call for a halt to the use of mRNA vaccines. “It’s hard to believe that Dr. Ladapo actually made that statement.” Ta.
Ladapo, who was appointed Florida Surgeon General by Gov. Ron DeSantis in September 2021, has been spreading misinformation about COVID-19 and making unsubstantiated statements about COVID-19 vaccinations in the state. , has led a growing number of recommendations. In 2022, the Florida Department of Health did not recommend COVID-19 vaccination for children under age 5, as well as healthy children ages 5 to 17. In the same year, Ladapo did not recommend mRNA COVID-19 vaccination for men aged 18 to 39 based on: Florida Department of Health’s seriously flawed analysis of cardiac deaths. Ladapo was later found to have edited the study to make the vaccine appear more dangerous.
In September 2023, he recommended that Floridians under 65 not receive the latest coronavirus vaccine. Then in October, he called the latest vaccine recommendations “anti-humane” and said that as a doctor he would be “very uncomfortable” recommending vaccines. Anyone.
Ladapo originally addressed FDA and CDC officials in a Dec. 6 letter about DNA-related residue concerns. He cited a 2007 FDA guidance document on DNA vaccines that contain plasmids, a type of circular DNA, and said the FDA’s recommendations for assessing the risk of such vaccines’ DNA becoming integrated into the genome also apply to mRNA vaccines. falsely claimed that it applied.DNA vaccines are not yet on the market in the United States.
In a Dec. 14 response letter, Marks wrote that the guidance was not relevant. “This guidance was developed for DNA vaccines themselves, not DNA as a contaminant in other vaccines, and does not apply to mRNA COVID-19 vaccines.”
Despite this clarification, Ladapo responded to the FDA’s letter calling for a halt to the use of mRNA vaccines, while continuing to falsely claim that the agency is contrary to its own recommendations. “The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have always been lax about the safety of COVID-19 vaccines, but as required by their own guidelines, testing for DNA and human genome integration is essential. “It is intolerable that vaccines are known to be contaminated with foreign DNA,” Ladapo said in a Jan. 3 post on Platform X, formerly known as Twitter. .
As I have written previously, DNA is the main component of DNA vaccines, but only residual amounts are present in mRNA vaccines. For DNA vaccines to work, they need a mechanism to get the DNA into the cell’s nucleus. However, mRNA vaccines primarily contain mRNA and only need to enter the body’s cells.
Even in DNA vaccines, DNA incorporation is only a theoretical risk and has not been shown to be a safety issue. FDA guidance states that animal integration studies (analyzing genomic DNA from various tissues for signs of integration) should only be conducted for DNA vaccines if specific levels of plasmids are shown to persist in animal tissues. We recommend that you do so.
Nevertheless, available data on mRNA COVID-19 vaccines show no signs of genome disruption. Professor Marks said animal studies showed “no evidence of genotoxicity from the vaccine”, meaning there was no evidence of damage to chromosomal DNA.
“Furthermore, we now have access to global surveillance data on more than 1 billion mRNA vaccines administered to date, and we have no evidence of harm to the genome, such as increased incidence of cancer. There is nothing,” Marks said.
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