CDC and FDA 'Abrogating Their Duty to Actually Protect Human Beings’: Dr. Ladapo

The Florida Surgeon General denounced the insufficient levels of clinical trials needed to distribute vaccines on a global level.
CDC and FDA 'Abrogating Their Duty to Actually Protect Human Beings’: Dr. Ladapo
Florida surgeon general Dr. Joseph Ladapo in Tampa, Fla. on Oct. 15, 2022. (York Du/The Epoch Times)
Jan Jekielek
Naveen Athrappully

Florida Surgeon General Dr. Joseph Ladapo criticized the rollout of the latest iteration of COVID-19 vaccines after approval from the CDC and FDA—blasting the federal agencies for a lack of sufficient clinical trials.

Dr. Ladapo said that the vaccines never underwent significant trials with a large enough sample population, and in the rare instance they did, the trials did not go on long enough to study the effects properly. New detailed studies are needed, he claimed, given the evolutionary nature of the virus.

“So if you were to survey Americans, and ask them whether there were clinical trials of this specific booster being pushed at this particular time—I'm sure that if you went into clinics where people were lining up to receive it, most of them, if nearly not all of them, would say ‘there have to be clinical trials, how could there not be clinical trials?’” Dr. Ladapo said in an American Thought Leaders interview on Sept. 20.

“And for the FDA to point to clinical trials that were performed almost three years ago … as justification for making a decision now when immunity is completely different, the circulating viruses and their pathogenicity, how serious they are in terms of the gravity of illness they cause, is completely different … It's like they've just let go of the steering wheel in terms of abrogating their duty to actually protect human beings.”

When interviewer Jan Jekielek asked about the booster causing a one-in-50 adverse event in a Moderna clinical trial, Dr. Ladapo replied that the sample size for the 1:1 trial involving 100 people was insignificant.

“We have junior researchers at universities who will get small pilot grants, and they managed to enroll more than 100 people in a clinical trial. It leaves me and many other scientists and doctors wondering—is anyone going to say anything about the emperor not wearing clothes? You know, it's just completely ludicrous that they would do this and present it as evidence,” said the doctor.

He added that there was no public disclosure of the adverse event. The study was used by the CDC to recommend boosters for the 2023 fall season.

“These clinical data also informed the selection of XBB.1.5-containing monovalent Covid-19 vaccines as recommended by the U.S. FDA for use in 2023-2024 immunizations,” said the preprint. There were also no efficacy estimates, that is, comparative data with placebo controls.

The 1-in-50 or 2-Percent ‘Secret’ Adverse Event

Other experts chimed in to express their discontentment with the non-disclosure of the adverse event connected to Moderna’s booster as well as the federal agencies’ urgency to release it to the public.
 People receive the Pfizer COVID-19 vaccine at a vaccination center in Salisbury, England, on Jan. 20, 2021. (Finnbarr Webster/Getty Images)
People receive the Pfizer COVID-19 vaccine at a vaccination center in Salisbury, England, on Jan. 20, 2021. (Finnbarr Webster/Getty Images)
University of California-affiliated researcher Dr. Tracy Beth Hoeg, MD, said in a Sept. 13 X post, “Of the 50 study participants that got the Moderna monovalent vax @CDCgov universally recommended today, 1/50 (2%) had a medically-attended adverse event related to the vax W/unknown clinical benefits how can CDC say w certainty benefits outweigh risks 4 all?”
John Hopkins professor Dr. Marty Makary, MD, responded in a Sept. 14 X post: “What if I told you 1 in 50 people who took a new medication had a ‘medically-attended adverse event’ and the manufacturer refused to disclose what the complication was, would you take it? And what if the theoretical benefit only lasted for a 3-mo window after which time the benefit is gone? and that the FDA cleared it without any human outcomes data, would you take it? and that European regulators are not universally recommending the same medication for everyone as the CDC is? and that Drs. Ashish Jha and Mandy Cohen are making unsupported claims that it reduces hospitalizations, long-Covid, and makes you less likely to spead Covid (if the manufacturers made those same claims they could be fined by the FDA for making false marketing claims beyond it's approved indication).

“That's the new Moderna Covid vaccine. FDA or Moderna (I can't tell the difference sometimes) should disclose the details of the clinical trial complication rather than keeping it secret.”

Dr. Ladapo said in the interview that vaccine safety will never be understood until undergoing a “proper” clinical trial. “And that just hasn't happened for these drugs.”

There was a large study done in 2020 with significant control groups, from which, important data was collected, he said. “But unfortunately, these trials lasted a few months” as individuals, who were in the control group, opted to take the vaccine. “So we lost our control groups.”

“And ever since then, every subsequent study has not been sufficiently large, or sufficiently long to really understand characteristics of these vaccines.”

Even if hundreds of millions went on to take the vaccine, there were many medical conditions that arose following the inoculation like myocarditis, tinnitus, and others, said the doctor.

“Look at the thromboembolic events that some studies have found an increased risk for. Things like strokes, things like heart attacks. So there are a number of these different types of side effects. Even one study found an increased risk of appendicitis, actually even I think it was actually more than one study.”

He said that discussions surrounding whether people should get vaccinated are at a considerably high level, whereas those on the resultant medical conditions are extremely low.

‘Negative Effectiveness’

Dr. Ladapo talked about the negative effects of the vaccines in the interview.

“So at this point, there are multiple studies in Iceland, I think, Argentina, the United States, the Middle East, good research groups, using different methods are finding that these vaccines after some months, particularly the boosters are associated with negative effectiveness, which means that individuals who receive them become more at risk of contracting COVID 19, after some time, than individuals who didn't.”

 Empty COVID-19 vaccine vials at a vaccination center in Rosenheim, Germany, on April 20, 2021. (Christof Stache/AFP via Getty Images)
Empty COVID-19 vaccine vials at a vaccination center in Rosenheim, Germany, on April 20, 2021. (Christof Stache/AFP via Getty Images)

Dr. Ladapo said that some of the study authors found the results surprising, and thought it could be a “representative bias” rather than an actual biological effect. They made changes to the study like a sensitivity analysis where they removed the young people. But the findings persisted. In this circumstance, they made up “ridiculous” explanations like “when people were vaccinated, they may start taking more risks compared to people who aren't.”

“It's very clear that when we're talking about these later vaccines to boosters, the class of people that are getting them tend to be more risk averse, older, wealthier, more educated, more politically liberal. So this idea that they're taking more risk is totally nonsense.”

Following the vaccine rollout announcement, the Florida Department of Health issued a health advisory (pdf) recommending “against” the use of COVID-19 boosters for anyone under 65, based on the high rate of global immunity and currently available data.

“While the initial mRNA COVID-19 vaccines were authorized by the United States Food and Drug Administration (FDA) utilizing human clinical trial data, the most recent booster approval was granted in the absence of any meaningful booster-specific clinical trial data performed in humans.

“In both cases the federal government has failed to provide sufficient data to support the safety and efficacy of the COVID-19 vaccines. Health care providers are expected to include the information in this guidance in discussions with patients regarding the mRNA COVID-19 vaccines.”

Dr. Ladapo said that the general public has been “programmed” to believe that the vaccine is 100 percent safe and effective.

“The American people and people around the world have been blanketed with messages about safe and effective and about you know—this is the right thing to do.”

The constant messaging has “penetrated the consciousness” and shaped people's beliefs. This constant pressure on the consciousness makes the average individual take what was “completely wrong, a year or two years ago” to be “normal” now.

The messaging, especially from mainstream media, “shifts people's people's views or the prism of the lens with which they view life.”

Jan Jekielek is a senior editor with The Epoch Times and host of the show "American Thought Leaders." Jekielek’s career has spanned academia, media, and international human rights work. In 2009, he joined The Epoch Times full time and has served in a variety of roles, including as website chief editor. He was an executive producer of the award-winning Holocaust documentary film "Finding Manny."