Florida Surgeon General Joseph Ladapo will instruct the state’s Department of Health (FDOH) to advise against COVID-19 vaccines for anyone under 65.
His comments came during a roundtable discussion on Sept. 13 with Florida Gov. Ron DeSantis and Drs. Jay Bhattacharya, Tracy Hoeg, and Patrick Whelan about updated formulations of the vaccines.
During the video conference, they all pushed back strongly against a recent recommendation by the director of the Centers for Disease Control and Prevention (CDC), who said everyone six months and older should get the new COVID-19 vaccines.
“Vaccination remains the best protection against COVID-19-related hospitalization and death,” CDC director Dr. Mandy K. Cohen advised.
But roundtable participants haven’t been convinced by the CDC’s statements.
“With the amount of immunity that’s in the community—with virtually every walking human being having some degree of immunity—and the questions we have about safety and about effectiveness—especially about safety—my judgment is that it’s not a good decision for young people, for people who are not at high risk [to continue with vaccines] at this point in the pandemic,” Dr. Ladapo said.
The other roundtable experts agreed that there isn’t enough data on the vaccine and how it affects people to consider it to be safe and effective. This lack of information leaves both patients and physicians unable to make a truly informed decision, they said.
People “should not be misled into thinking that there are clinical trials of the boosters that are indicating that they will benefit, since that isn’t true,” Dr. Ladapo said. He described Dr. Cohen’s recommendation of the vaccine as “cheerleading.”
“It’s absolutely shocking to me,” Dr. Bhattacharya said, “to watch the FDA [U.S. Food and Drug Administration] and the CDC abdicate the responsibility they have to the American public about these medications.
“The reason you need clinical trial data is to guide physicians in their recommendations that they give to guide patients.”
Normally, a randomized trial would provide the data to answer patients’ questions about the benefits and risks they could experience when taking a medication, he said.
“We don’t have those data for these trials for this new, updated booster,” he said.
“We don’t know that it protects you against being hospitalized, and we don’t know that it protects you against dying from this disease.”
Dr. Hoeg said she’s concerned that the limited studies of the vaccine might not provide an accurate picture of how safe and effective they really are. She warned about known adverse effects connected to taking the vaccines, and described studies that seem too narrow to properly test for the true risk.
“It makes it difficult for physicians to give recommendations because we don’t know whether or not the benefits of these vaccines are going to outweigh the harms,” she said. That’s a “disservice” because Americans “don’t have the information to make a good decision.”
Adverse Effects
Even in a test of the new Moderna vaccine, one of the 50 people in the study suffered from a “medically attended adverse event,” Dr. Hoeg said. But those details weren’t reported, she said.
That amounts to 2 percent of those studied, which she described as “very concerning.”
Dr. Whelan said he was involved in a trial on the original vaccine, which found one out of 800 vaccinated suffered an adverse event.
“We didn’t address the question of how many deaths or hospitalizations were averted by vaccination,” he said. “And the new boosters have not been tested, as Tracy was saying, for safety and effectiveness at all, and certainly not in children at this point.”
But Dr. Whelan also addressed the “severity” of the situation, stating that each death, especially a child’s death from COVID-19, “represents an immeasurable loss for those families, both to the families and to society generally.”
He advocated for creating a system to reach out to parents of COVID-vaccinated children a week, a month, and six months after their child’s shots to be sure they haven’t had an adverse reaction. Trying to navigate reporting shot reactions to the VAERS system can be complicated, he said.
VAERS is the federal government’s Vaccine Adverse Events Reporting System.
Mr. DeSantis asked the doctors if another drug would have gotten FDA approval with the same limited data.
“There’s no chance that a product like this would have gone to market with the kinds of data that are currently available for it,” Dr. Bhattacharya said.
However, the administration of President Joe Biden and some state governments in 2021 decided to mandate the vaccine for government employees instead of allowing people to decide for themselves if they wanted to receive the FDA-expedited product.
Dr. Ladapo expressed sympathy for those who have been devastated by COVID-19. But the lack of data and negative findings about the vaccines are “an important safety signal,” he said.
Recent studies connect the vaccine to incidents of myocarditis, he said. And spike proteins have been found in the bloodstream of vaccinated people months after getting the shot, he said.
Though health officials with the administration of President Joe Biden recommend COVID-19 vaccines for all people older than six months, many European countries recommend them only for people who are immunodeficient or at least 65.
“How can you best reduce people’s risk of having a serious outcome that no one wants to have?” Dr. Ladapo asked rhetorically. “Unfortunately, we do not have the data at this point with the level of immunity we have in the community to answer that question.”
From The Epoch Times
