Top FDA Heads Admit 'Risks of Vaccination' After Florida Surgeon General Call for Halt in Use of COVID-19 mRNA Jabs: Letter in 'Journal of the American Medical Association'

Despite apparently promising the FDA "will do our part... to help explain the benefits and risks of vaccination," agency leaders Califf and Marks mention no such risks.

Two top Food and Drug Administration (FDA) leaders on Friday admitted in a letter published on Friday in the Journal of the American Medical Association (JAMA) that there are “risks” associated with the COVID-19 vaccine.

The move comes only three days after Florida Surgeon General Dr. Joseph A. Ladapo sent a letter to the FDA and Center for Disease Control and Prevention (CDC), questioning the safety assessments and the discovery of billions of DNA fragments per dose of the Pfizer and Moderna COVID mRNA vaccines that can “transform a healthy cell into a cancerous cell” in the human body.

In their new letter, FDA Commissioner Dr. Robert Califf and Director of the FDA’s Center for Biologics Evaluation and Research Dr. Peter Marks are seemingly calling for increased transparency regarding the proven risks associated with COVID jabs.

They are doing so in light of the “increasing number of people in the US are now declining vaccination for a variety of reasons, ranging from safety concerns to religious beliefs,” their letter reads.

Drs. Califf and Marks also admit the uptake of the updated COVID vaccine in Americans older than 65 years is “only about 35%.”

The doctors go on to “urge the clinical and biomedical community to redouble its efforts to provide accurate plain-language information regarding the individual and collective benefits and risks of vaccination.”

“All those working in health care, while being straightforward about the risks, need to better educate people regarding the benefits of vaccination, so that individuals can make well-informed choices based on accurate scientific evidence,” they write.

The FDA leaders then implore “all those directly interacting with individuals in a health care setting,” including office staff, retail pharmacists, and primary care physicians, to “focus at every appropriate opportunity on helping to ensure that individuals have the necessary information to make informed choices regarding vaccination, considering the benefits and risks.”

They end their letter, ostensibly promising, “We will do our part at FDA by continuing to provide health care clinicians and the general public with timely and accurate information in plain language to help explain the benefits and risks of vaccination.”

However, despite repeatedly calling for FDA leaders—which they are—to be more transparent about the risks associated with COVID vaccines, and even promising to do so themselves, Califf and Marks mention no such risks in their letter.

The omission is at odds with their letter’s apparent emphasis on transparency.

Dr. Richard Bartlett, a 30-year Texas physician and recipient of the Texas Health and Human Services (HHS) Meritorious Award, criticized Califf and Marks’ exclusion of risk data in their letter.

“In my opinion, FDA Commissioner Califf calling for COVID shot Transparency is like Hitler calling for world peace,” he said. “Patients have a fundamental right to informed consent. Informed consent is being told all treatment options, the risks and benefits of all treatment options, and any financial conflicts of interest.”

FDA’s Poor Track Record on COVID-19 Vaccine Safety Data Transparency

In fact, it was the FDA that asked to be given no less than 55 years before it would make public its COVID vaccine safety data back in 2021.

The FDA’s request was in response to a Freedom of Information Act (FOIA) request from a group of more than 30 professors and scientists from universities including Yale, Harvard, UCLA, and Brown demanding about 450,000 pages worth of Pfizer’s vaccine safety data from the health agency.

The FDA claimed it needed until 2076 to release the data because the time it takes to get the documents would “vary depending on the complexity of the request and any backlog of requests already pending at the agency.”

The agency pleaded for decades before releasing the safety information even though the plaintiffs requesting the data explained how the immediate release could help reassure those who prioritize vaccine safety that the shot is “safe and effective and, thus, increase confidence in the Pfizer vaccine.”

It took a four-page court order from a Trump-appointed federal judge in Texas to force the FDA, against its wishes, to make public the data it relied on to license Pfizer’s COVID shot.

U.S. District Judge Mark Pittman in Fort Worth wrote that the FOIA request was indeed “of paramount public importance,” and ordered the agency to immediately begin turning over 55,000 pages of data per month.

That data would reveal hundreds of adverse reactions to the vaccine that Pfizer and the FDA knew about before authorizing its use among adults, the elderly, and children.

Dr. Bartlett weighed in: “On FDA Commissioner Califf’s watch, the FDA was served a FIOA request for the COVID shot data so patients could be given informed consent. The FDA acknowledged having the COVID shot risk/benefit data requested and recognized being legally required to release the data. Despite that, the FDA replied by saying it didn’t want the public to see the COVID shot data for 55 years. What was the FDA hiding from the public?”

He continued: “Two weeks later the FDA changed its stance and said it didn’t want to make the data public for 75 years. Nothing says ‘Trust the Science’ like not wanting to release vaccine safety data for 75 years!”

Dr. Bartlett, a board member of the group that sued the FDA, Public Health and Medical Professionals For Transparency, described his experience of Judge Pittman’s decision:

“Federal Judge Mark Pittman told the FDA that the public has a right to know the truth. The FDA pushed back saying it didn’t have enough staff to release the shot data in its computers for 75 years,” he explained. “I was in the courtroom that day. I thought, ‘How many people does it take to push send? To push print?’”

“The judge ordered the FDA to release the evidence. The results were damning,” Bartlett added. “The COVID shot manufacturer (Pfizer Inc.) made a list of 1,200 potential lethal and debilitating medical conditions associated with the COVID shots, and the list was finally released by the FDA. Safe and Effective?”

New Peer-Reviewed Data Linking COVID-19 Vaccine to Adverse Events

Recently, the COVID vaccine has been linked to serious cardiovascular, respiratory, immune, digestive, and nervous system conditions.

For example, a November publication in Translational Pediatrics discovered that the rate of emergency department attendance and hospitalization for chest pain among children saw a significant increase after the introduction of the COVID-19 vaccination. The study also highlights an increase in concerns over vaccine-related myocarditis. It cited a sharp rise in cardiac enzyme testing, from virtually 0% pre-vaccination to 26.1% post-vaccination.

A study published the same month in Scientific Reports found a 200% spike in pharmaceutical drug injuries between 2020 and 2021 “due to the massive inclusion of COVID-19 vaccine reports.”

Moreover, a peer-reviewed study published in December in the journal Vaccine: X confirmed that vaccinated individuals aged 5 years and older experienced adverse events of special interest (AESIs) occurring within 42 days of vaccination. These included “strokes, cerebral venous thrombosis (CVT), acute myocardial infarction, myocarditis/pericarditis, pulmonary embolism, immune thrombocytopenia, convulsions and appendicitis,” according to the study.

A study published the same month in the journal Infection reported the reappearance of Kaposi’s sarcoma (KS), a type of cancer that develops from the cells that line lymph or blood vessels, in a 48-year-old male patient who recently received multiple COVID-19 vaccinations.

Another study published the same month in Nature uncovered a significant unintended “glitch” immune response triggered by mRNA COVID vaccines in approximately one-third (25-30%) of recipients. A component of the vaccine—known as N1-methylpseudouridine—causes the ribosome, the protein-making machinery in the body, to “slip” around 10% of the time in a process called “frameshifting.” The phenomenon translates into the production of a protein that the body identifies as foreign, resulting in an immune system response and the production of unintended “rogue” proteins. This elicits an immune system “flare-up” response in which the body “attacks” the proteins it has made.

A study published this month in Cureus confirmed that 41% of women experience menstrual disruptions after receiving a COVID vaccine, the number increasing to 44.1% after a second dose.

A study also published this month in the European Journal of Neurology found that compared to unvaccinated patients, vaccinated patients were four times more likely to contract neurological disorders.

Yet another January publication in Reproduction & Fertility raised concerns over the COVID vaccine negatively affecting sperm quality in men. “Based on the results of the current study, it may be clearer than before that COVID-19 vaccination effects on semen should be of concern,” the authors write.

None of these new studies were mentioned by Drs. Califf and Marks in their letter.