Florida Surgeon General accuses CDC and FDA heads of ignoring 'many of the risks associated with mRNA COVID-19 vaccines'



Florida Surgeon General Joseph Ladapo has written a letter to Centers for Disease Control and Prevention Director Rochelle Walensky and U.S. Food and Drug Administration Commissioner Robert Califf, accusing the public health officials of ignoring many risks related to mRNA COVID-19 vaccines.

"Your ongoing decision to ignore many of the risks associated with mRNA COVID-19 vaccines, alongside your efforts to manipulate the public into thinking they are harmless, have resulted in deep distrust in the American health care system," Ladapo declared in the May 10 letter.

He asserted that their "collective decisions to deny that natural immunity confers comparable or superior protection to COVID-19 vaccination, push mRNA COVID-19 boosters for the young and healthy, and delay acknowledging the risks of vaccine-induced myocarditis have only sowed doubt between the American people and the public health community."

The Sunshine State public health official listed a number of requests — among them, he pressed for the officials to "report why randomized clinical trials were not required prior to the approval of mRNA COVID-19 boosters, including the new bivalent booser." He called for them to "Report the number of adolescents that have died within days of receiving a second dose or booster of the mRNA COVID-19 vaccine," and to "Explain why you have not required Pfizer to report results of its randomized trial in pregnant women ... which was completed in July of 2022." He also made various other requests.

\u201cWhen I asked the feds for more honesty and transparency around COVID-19 vaccine data, they replied with a word salad of pandering and gaslighting. \ud83d\ude44 Here\u2019s my response. Let\u2019s try again, @CDCgov @US_FDA.\u201d
— Joseph A. Ladapo, MD, PhD (@Joseph A. Ladapo, MD, PhD) 1683763252

In a March response to an earlier letter from Ladapo, Walensky and Califf had promoted COVID-19 vaccination.

"We stand firmly behind the safety and effectiveness of the mRNA COVID-19 vaccines, which are fully supported by the available scientific data. Staying up to date on vaccination is the best way to reduce the risks of death and serious illness or hospitalization from COVID-19. Misleading people by overstating the risks, or emphasizing the risks without acknowledging the overwhelming benefits, unnecessarily causes vaccine hesitation and puts people at risk of death or serious illness that could have been prevented by timely vaccination," they wrote.

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'Does that sound safe and effective?' Florida had 1,700% increase in vaccine adverse event reports after COVID-19 vaccine came out



There was a whopping 1,700% rise in Vaccine Adverse Event Reporting System reports in Florida after the COVID-19 vaccine came out, according to the state's health department.

"In Florida alone, there was a 1,700% increase in VAERS reports after the release of the COVID-19 vaccine, compared to an increase of 400% in overall vaccine administration for the same time period," according to a health alert. "The reporting of life-threatening conditions increased over 4,400%," the alert notes. "There is a need for additional unbiased research to better understand the COVID-19 vaccines' short- and long-term effects."

"Florida saw a 1,700% increase in adverse event reports after COVID-19 vaccinations. Does that sound safe and effective? I didn't think so either. That's why we released this health alert. Just because 'correlation ≠ causation' doesn't mean we should abandon common sense," Florida surgeon general Joseph Ladapo tweeted.

\u201cFlorida saw a 1,700% increase in adverse event reports after COVID-19 vaccinations. Does that sound safe and effective? I didn\u2019t think so either. That\u2019s why we released this health alert. \n\u00a0\nJust because \u201ccorrelation \u2260 causation\u201d doesn\u2019t mean we should abandon common sense.\u201d
— Joseph A. Ladapo, MD, PhD (@Joseph A. Ladapo, MD, PhD) 1676567285

Ladapo raised the issues in a letter to U.S. Food and Drug Administration commissioner Robert Califf and Centers for Disease and Control and Prevention director Rochelle Walensky, suggesting that the statistics are likely indicative of risk related to mRNA COVID-19 vaccines.

"This increase in adverse events, compared to the percent increase in vaccine use, further explains the significant uptick we are seeing in VAERS reports. These findings are unlikely to be related to changes in reporting given their magnitude, and more likely reflect a pattern of increased risk from mRNA COVlD-19 vaccines. We need unbiased research, as many in the academic community have performed, to better understand these vaccines' short- and longterm effects," Ladapo wrote.

"To claim these vaccines are 'safe and effective' while minimizing and disregarding the adverse events is unconscionable," he wrote. "As a father, physician, and Surgeon General for the State of Florida, I request that your agencies promote transparency in health care professionals to accurately communicate the risks these vaccines pose. I request that you work to protect the rights and liberties that we are endowed with, not restrict, and diminish them."

\u201cWhile the Biden administration and Big Pharma continue to blindly push mRNA COVID-19 vaccines, Florida remains dedicated to responding to public health concerns guided by data and common sense.\u201d
— Joseph A. Ladapo, MD, PhD (@Joseph A. Ladapo, MD, PhD) 1676508717

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Horowitz: Federal judge overseeing J6 cases announces retirement, no interest in presiding over 1,000 more cases



We all knew this was coming, but in our hearts we were praying the persecutions would finally end. Anyone who merely stepped foot into the Capitol (and a few who didn’t) was charged and treated 1,000 times worse than anyone else for commensurate crimes. Now, in a bombshell revelation, Judge Thomas Hogan, one of the main D.C. district judges overseeing the J6 cases, announced in a conference call with defense attorneys that he is suddenly retiring. He further said that there are 1,000 additional cases coming down the pipeline from the DOJ (thanks to McConnell giving the department more funding), and he has no interest in presiding over them for another four to five years.

\u201c\ud83d\udea8The Hon. Thomas Hogan just informed us during a status conference for Ryan Nichols that he is retiring at 85.\n\nHe also informed us that the Dept. of Justice said there are another 1k J6 cases forthcoming and he has no interest in presiding over those cases for the next 4-5 yrs.\u201d
— Joseph D. McBride, Esq. (@Joseph D. McBride, Esq.) 1672932049

This is quite the revelation for the two-year anniversary of the event that now appears to be more of an FBI provocation and Capitol police misfiring on crowd control than an insurrection, certainly not a planned one. Oh, and don’t count on one of those thousand being Ray Epps.

But what are we going to do about it? Well, ask yourself the question we should always ponder in these situations: What would the Democrats do were the shoe on the other foot? Imagine if the Trump administration rounded up every person who merely attended a BLM riot. Well, for starters, that would literally rope in several million people. Mind you, these events were often riots from the onset, not protests turned violent by some, and they occurred day after day after day. No conservative, on the other hand, dared follow up on January 6, even with a peaceful protest. But what would Democrats do?

On the federal level, they would have held up the budget bill for as long as it took for the DOJ to stop these political persecutions. Republicans, thanks to McCarthy’s refusal to fight McConnell until it was too late, kicked that leverage until the end of the year. Now Biden can trample civil liberties without any check. And no, weak hearings on the FBI won’t scare them, especially when GOP leaders refuse to even mention the persecution of January 6 protesters specifically.

But more importantly, there is no doubt that blue states would harbor all their defendants accused of a crime, especially if they were peacefully protesting. They would not allow the FBI to come into their states and grab people on nebulous crimes, and they would certainly offer legal defense help. At some point, red-state governors and legislatures will have to step up and say no, or at least assist the defendants and place roadblocks in front of federal agents engaging in Soviet-style persecutions.

Here’s why. While BLM rioters beat thousands of cops, trespassed and looted private property, and destroyed public property with impunity, even those Jan. 6 protesters who never even committed a minor offense are being indicted under 18 U.S.C. 231(a)(3). This is the statute that prescribes up to five years in prison for “Whoever commits or attempts to commit any act to obstruct, impede, or interfere with any fireman or law enforcement officer lawfully engaged in the lawful performance of his official duties incident to and during the commission of a civil disorder …”

Even before roping in the next group of protesters, this statute has already incriminated people for merely engaging in constitutionally protected assembly and speech. The dangerous phrase “incident to and during commission of a civil order” can be used to tag anyone who merely talked to a police officer during an event where other individuals in another part of the Capitol acted violently, thereby distracting them from their duty.

Thus, the plain meaning of this statute was always unconstitutional, and now that officials are applying it even against mere speech or assembly, it must be blocked with the same vigor with which the Sons of Liberty thwarted the Quartering Act.

It’s also a fundamental violation of equality under the law in relation to the right to protest. Think of all the times BLM protesters – even the ones who weren’t violent – taunted, cursed at, and filmed police officers. They could easily have been roped into this statute, because their behavior definitely impeded and interfered with their response to the civil disorder.

Consider how thousands of rioters were allowed to vandalize 1,500 buildings, destroy 700 buildings, and block streets and terrorize motorists with impunity, just in Minneapolis alone. Less than 10% of those arrested during the endless riots in Portland wound up being prosecuted. According to a report by the Major Cities Chiefs Association, more than 2,000 officers were injured in the 574 riots across the U.S. and Canada over the course of two months. Most of those who had a direct hand in those injuries were not punished, must less protesters who were incidental to it. We cannot allow these selective enforcements of an unconstitutional, vague statute that cuts to the heart of fundamental freedoms be used as a tool to round up political opponents.

To that end, state legislatures should direct attorney generals’ offices to inquire into the names of those within the state who are being investigated by the feds for January 6-related activities. Anyone being investigated, charged, or harassed by the feds under 231(a)(3) without any other evidence of having committed a meaningful crime should trigger a set of policies from the executive branch of that state to thwart the persecution at all costs. At a minimum, the states should create a legal defense fund to argue on behalf of those individuals who are clearly being targeted for their political beliefs, not for any violent actions.

Two years into the “Reichstag moment” of the Jan. 6 agent provocateur setup, Republican leaders like McCarthy still refuse to realign their position with the new facts on the ground. Rep. Tom Cole (R-Okla.), who just called for more funding to rope in even more Jan. 6 defendants, is slated to be Rules Committee chair. This latest revelation from a straight-shooting judge should be a wake-up call that we need wholesale change among national Republicans.

Even those Republicans who bought into the regime narrative until now must concede that anyone who remotely acted violent has long since been punished and almost assuredly over-punished. Any further effort to seek indictments reeks of the worst power plays in tyrannical countries. We need an effort to call out the immoral and despotic treatment of political protesters and a call for actions that reflect the spirit of how our founders dealt with similar violations of due process, legal norms, and basic human rights. But their ineptitude shouldn’t stop red states from picking up the slack and declaring, “Not in our state.”

“January 6” as a slogan no longer symbolizes what the left thinks it does, and when the discovery process of the actual trials commencing this month reveals the truth of what really happened, the political cowards will be on the wrong side of history.

COVID-19 vaccines should be added to immunization schedules for kids and adults, CDC advisory panel recommends



The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted unanimously on Thursday in favor of recommending that COVID-19 vaccines be placed on the immunization schedules for children and adults.

"Today, CDC’s Advisory Committee on Immunization Practices (ACIP) recommended updates to the 2023 childhood and adult immunization schedules, which includes incorporating additional information for approved or authorized COVID-19 vaccines. CDC only makes recommendations for use of vaccines, while school-entry vaccination requirements are determined by state or local jurisdictions," a press release from the government agency noted.

"It has been almost two years since COVID-19 vaccines were first rolled out in the U.S., and nearly 630 million doses have since been administered nationwide, providing people with critical protection against severe COVID-19. ACIP's recommendation to add COVID-19 vaccines to the routinely recommended vaccine schedule represents another step in the nation's recovery," the release claimed. "The updated schedules and program guidance will be published in early 2023."

The CDC was already recommending COVID-19 vaccination for people aged 6 months and older.

While the move to add the vaccines to the vaccine schedule for kids does not impose any sort of vaccination mandate for schools around the U.S., local policy makers could potentially look to the schedule's recommendations for guidance.

"The ACIP voted unanimously to add the Covid vaccine to the CDC’s recommended immunization schedule for kids. The CDC will likely approve it. The CDC already recommends everyone 6 months and older receive the vaccine so the vote today was not a surprise, merely a formality," Dr. Nicole Saphier tweeted. "Today's vote in itself is not a mandate. When state/local authorities form vaccine requirements for school & other activities, they often defer to the CDC’s immunization schedule. It is to be seen whether Covid vaccines will be required for some kids to attend school," she added.

\u201cToday\u2019s vote in itself is not a mandate.\n\nWhen state/local authorities form vaccine requirements for school & other activities, they often defer to the CDC\u2019s immunization schedule. \n\nIt is to be seen whether Covid vaccines will be required for some kids to attend school. 2/2\u201d
— Nicole Saphier, MD (@Nicole Saphier, MD) 1666288710

Florida surgeon general Joseph Ladapo tweeted on Wednesday, "Regardless of what @CDCgov votes tomorrow on whether COVID-19 vax are added to routine child immunizations - nothing changes in FL. Thanks to @GovRonDeSantis, COVID mandates are NOT allowed in FL, NOT pushed into schools, & I continue to recommend against them for healthy kids."

\u201cRegardless of what @CDCgov votes tomorrow on whether COVID-19 vax are added to routine child immunizations - nothing changes in FL. \n\nThanks to @GovRonDeSantis, COVID mandates are NOT allowed in FL, NOT pushed into schools, & I continue to recommend against them for healthy kids.\u201d
— Joseph A. Ladapo, MD, PhD (@Joseph A. Ladapo, MD, PhD) 1666127639

Feds reject Florida surgeon general's warnings about dangers of mRNA vaccinations



On October 7, Florida Surgeon General Dr. Joseph Ladapo issued guidance for mRNA COVID-19 vaccines, stating that with "a high level of global immunity to COVID-19, the benefit of vaccination is likely outweighed by this abnormally high risk of cardiac-related death among men" in the 18-39 age group. The guidance cited analysis that showed an 84% increase in the relative incidence of cardiac-related deaths in this demographic within 28 days following mRNA vaccination.

On Monday, elements of the federal health establishment responded, rejecting Ladapo's guidance and restating their advocacy for Americans of all ages to get vaccinated.

Ladapo's censored guidance

The guidance issued last week by the Florida surgeon general referred to a self-controlled case series wherein "only individuals who have experienced an event are included and all time invariant confounding is eliminated."

The analysis found a significant increase in the relative incidence of cardiac-related death among males 18-39 years old within 28 days following mRNA vaccination. Men over 60 were reportedly found to have a 10% increased risk of cardiac-related death within the same time frame.

\u201cFinally, is it really that hard to imagine that mRNA COVID-19 vaccines that increase myocarditis in young men by 10x, 20x, or 30x (see Karlstad et al,\nJAMA Cardiology, 2022) also increase the risk of cardiac death in that age group?\nOf course it's not, and we all know that. \ud83d\ude09\u201d
— Joseph A. Ladapo, MD, PhD (@Joseph A. Ladapo, MD, PhD) 1665403662

The guidance also noted that non-mRNA vaccines "were not found to have these increased risks among any population."

Ladapo, who previously suggested that healthy young children should not receive the experimental COVID-19 vaccine, recommended that those with preexisting heart conditions, such as myocarditis and pericarditis "should take particular caution when considering vaccination."

On Friday, Ladapo tweeted these findings along with his recommendation. Twitter, however, promptly blocked the post.

Florida Gov. Ron DeSantis' (R) press secretary, Bryan Griffin, called the censorship "an unacceptable and Orwellian move for narrative over fact."

\u201c.@Twitter censored data posted by the Florida State Surgeon General @FLSurgeonGen that showed an increase risk of cardiac-related death among males 18-39 years old within 28 days following mRNA vaccination. This is an unacceptable and Orwellian move for narrative over fact.\u201d
— Bryan Griffin (@Bryan Griffin) 1665323175

After receiving significant backlash for taking down the surgeon general's post, Twitter restored it on Sunday morning.

Ladapo told "Tucker Carlson Tonight" on October 10 that had it been known "two years ago or so that this vaccine would increase cardiac deaths in young men by 84%," there is no way it would have been approved.

\u201cWATCH \u2014 Florida Surgeon General Joseph Ladapo: "If it had been known two years ago or so, that this vaccine would increase cardiac deaths in young men by 84%, would they have approved it? The obvious answer is no."\n\u201d
— Election Wizard \ud83c\uddfa\ud83c\uddf8 (@Election Wizard \ud83c\uddfa\ud83c\uddf8) 1665453608

Federal backlash

The Orlando Sentinel reported that U.S. Department of Health and Human Services spokesman Sarah Lovenheim characterized Ladapo's guidance as "flawed and a far cry from the science," suggesting that the mRNA vaccines "have been proven safe and effective."

Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, stated, "We've continued to do these benefit-risk assessments, and they continue to be highly favorable, again, across all of the different age ranges ... including males 18-39."

Marks suggested that the analysis cited by Ladapo shouldn't dissuade Americans from getting a vaccine "despite the fact that yes, it is true that there could be some side effects."

Jason Salemi, an associate professor at the University of South Florida, reportedly suggested that "better-designed studies that are comprehensive and actually seek better data" should be conducted before potentially lifesaving recommendations are made.

Extra to elements of the federal and medical establishment, others without scientific bona fides have castigated Ladapo.

Former Florida Gov. Charlie Crist called Dr. Ladapo a "quack" on Twitter.

DeSantis' rapid response director answered back forcefully, suggesting Crist may be out of his depth.

\u201cBillboard lawyer who failed the bar twice thinks he knows more about science than a Harvard MD/PhD who was previously a professor at UCLA Medical School.\u201d
— Christina Pushaw \ud83d\udc0a \ud83c\uddfa\ud83c\uddf8 (@Christina Pushaw \ud83d\udc0a \ud83c\uddfa\ud83c\uddf8) 1665336383

This is not the first time that Ladapo has been met with criticism.

Dr. Ashish K. Jha, dean of Brown University School of Public Health, said earlier this year that to "say he's out of the mainstream would be an understatement." Jha and others have characterized Ladapo's recommendations as "unorthodox," particularly when it came to his 2020 claim that lockdowns "won't stop the spread."

Though allegedly "out of the mainstream," Ladapo was ultimately vindicated about lockdowns. A study published in the European Journal of Clinical Investigation found that lockdowns were unlikely to have provided significantly more benefits to slowing the spread of the disease than alternative voluntary measures.

Other studies

In terms of the disproportionate danger posed to young men by the mRNA vaccines, Ladapo's guidance is bolstered by findings from other studies.

An FDA-funded study published in June concluded that an "increased risk of myocarditis or pericarditis was observed after COVID-19 mRNA vaccination and was highest in men aged 18-25 years after a second dose of the vaccine."

A June 24 Canadian study supported by Public Health Ontario and the Public Health Agency of Canada found "increased rates of myocarditis or pericarditis following receipt of COVID-19 mRNA vaccines," with particularly higher incidences "among male individuals aged 18 to 24 years."

Another study published by the Journal of the American Medical Association reached the same conclusion, but suggested that the "risk should be considered in the context of the benefits of the COVID-19 vaccination."

Some experts are now reevaluating the benefits and deciding against giving mRNA vaccines to different demographics.

For instance, earlier this year, Sweden decided against recommending the vaccines to children ages 5-11.

Britta Bjorkholm of country's Health Agency stated, "With the knowledge we have today, with a low risk for serious disease for kids, we don't see any clear benefit with vaccinating them."

According to the American Academy of Pediatrics, 15.6 million American children ages 6 months to 4 years old have not been given a single COVID-19 vaccine dose; 17.8 million kids 5-11 have not received a dose; and 8.5 million kids ages 12-17 have not received a dose.

Last month, Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia and a member of National Institutes of Health (NIH) working group on vaccines, told CNN that he feared government health agencies might "say everybody should get it when in fact, the healthy young person is unlikely to benefit from the booster dose, and so I hope they targeted more specifically, to those really who are most likely to benefit."

\u201cDr. Paul Offit fears CDC will recommend new Covid boosters for all when "a healthy young person is unlikely to benefit ..."\n\nAfter CNN pushback: "If there's not clear evidence of benefit, it's not fair to ask ppl to take a risk, no matter how small. The benefit should be clear."\u201d
— Scott Morefield (@Scott Morefield) 1662058674

Last year, two top FDA vaccine regulators, Marion Gruber and Philip Krause, resigned ahead of the agency's agreement to recommend mRNA boosters. One month later, an FDA advisory panel voted 16-2 against recommending the booster shots for Americans ages 16 years and up.

Florida surgeon general recommends against mRNA COVID-19 vaccines for men ages 18-39: 'FL will not be silent on the truth'



Florida Surgeon General Dr. Joseph Ladapo is recommending against mRNA COVID-19 vaccines for men in the 18-39 age range. Both the Pfizer-BioNTech and Moderna vaccines fall into this category.

The Sunshine State's health department "conducted an analysis through a self-controlled case series" that "found there is an 84% increase in the relative incidence of cardiac-related death among males 18-39 years old within 28 days following mRNA vaccination," according to the guidance.

"Based on currently available data, patients should be informed of the possible cardiac complications that can arise after receiving a mRNA COVID-19 vaccine. With a high level of global immunity to COVID-19, the benefit of vaccination is likely outweighed by this abnormally high risk of cardiac-related death among men in this age group," the guidance states.

In a tweet, Ladapo noted that the state "will not be silent on the truth."

\u201cToday, we released an analysis on COVID-19 mRNA vaccines the public needs to be aware of. This analysis showed an increased risk of cardiac-related death among men 18-39. FL will not be silent on the truth.\n\nGuidance: https://t.co/DcWZLoMU5E\nPress Release: https://t.co/Y0r9yepi7F\u201d
— Joseph A. Ladapo, MD, PhD (@Joseph A. Ladapo, MD, PhD) 1665182429

The U.S. Centers for Disease Control and Prevention currently recommends that people remain "up to date" on its COVID-19 vaccinations. "You are up to date with your COVID-19 vaccines if you have completed a COVID-19 vaccine primary series and received the most recent booster dose recommended for you by CDC," the agency notes.

"COVID-19 vaccines available in the United States are effective at protecting people from getting seriously ill, being hospitalized, and dying," the CDC asserts. "As with other vaccine-preventable diseases, you are protected best from COVID-19 when you stay up to date with the recommended vaccinations, including recommended boosters."

Quadruple jabbed Pfizer chairman and CEO Albert Boura tested positive for COVID-19 in August, and then announced again in September that he had tested positive, though he noted that he had not yet received the new bivalent booster.

"Studying the safety and efficacy of any medications, including vaccines, is an important component of public health," Ladapo said, according to a press release. "Far less attention has been paid to safety and the concerns of many individuals have been dismissed – these are important findings that should be communicated to Floridians."

Video captures the moment Biden proudly reveals the REAL reason for wearing masks



President Joe Biden kicked off his trip to Asia with a virtue-signaling stunt-gone-viral as he arrived in South Korea. As he exited Air Force One, the president marched proudly down the stairs with a mask on — the outdoor stairs, with no one nearby — and then whipped the mask off to shake hands and chat closely with a group of roughly a dozen people.


WATCH: Joe Biden arrives in South Korea, wears mask as he exits plane by himself, then as he approaches another person, he takes it off. pic.twitter.com/UKTs8y6XCj

— The Post Millennial (@TPostMillennial) May 21, 2022

A video shared by the Post Millennial has racked up more than 2 million views on Twitter, with many commenters jumping to the president's defense by pointing out that he was following "the science" that says we should all wear masks on airplanes to stay "safe." Thinking people, however, noted how quickly our commander in chief forgot what masks are actually supposed to do — unless, of course, their only purpose is to virtue-signal.

do you not understand the reason for wearing a mask?
— 333 -.= (@333 -.=) 1653168507
Yes. It\u2019s to virtue signal.
— FunkyPox (@FunkyPox) 1653172128
To protect yourself while walking down a flight of stairs alone. We all get it.
— Dr. President Elect David \ud83c\udf51 (@Dr. President Elect David \ud83c\udf51) 1653169473
Yes we understand. Its virture signalling
— Yisraela (@Yisraela) 1653168912
Yes, political theatre
— TheCentralScrutinizer (@TheCentralScrutinizer) 1653226863
So, you can catch Covid from planes but not from people
— Joseph Landis (@Joseph Landis) 1653223653
You\u2019re pretty gullible if you think he wore that mask for entire flight. He did have it on the entire walk down the steps and on the runway. He took it off as soon as he got close enough to breathe on people. He\u2019s either a virtue signaler or he\u2019s senile. Pick one.
— Mimi's Thoughts (@Mimi's Thoughts) 1653306217

BlazeTV host Allie Beth Stuckey had her own hilarious take on how to address the left's tiresome virtue-signaling and hypocrisy over wearing masks.

Watch:

Turning the Tables on Mask Karens | #shorts youtu.be

Want more from Allie Stuckey?

To enjoy more of Allie’s upbeat and in-depth coverage of culture and politics from a Christian, millennial perspective, subscribe to BlazeTV — the largest multi-platform network of voices who love America, defend the Constitution, and live the American dream.

FDA and Florida clash over federal restriction of monoclonal antibody treatments



On Monday, the Food and Drug Administration removed two monoclonal antibody therapies from the list of approved COVID-19 treatments, subsequently forcing treatment sites to close despite these locations being pivotol to Florida's COVID-19 response.

The FDA made this announcement Monday in a press release stating that the bamlanivimab-etesevimab cocktail and the REGEN-COV treatments were to be removed from the list of emergency use authorizations.

It continued by saying that these treatments should only be used “when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments” because “data show these treatments are highly unlikely to be active against the omicron variant.” The FDA did not elaborate or provide the data.

The FDA argued against the preventive treatments, stating that “treatments are not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.”

The Washington Post reported that Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research and author of Monday’s press release, said that these monoclonal antibody treatments are “highly unlikely to be active against the omicron variant” and that “these treatments are not authorized to be used at this time.”

The FDA press release states that “these [monoclonal antibody] treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time.”

However, the press release did not mention that the Omicron variant can circumvent COVID immunity gained through vaccination.

In an interview with the French outlet Le Monde, Ugur Sahin, the CEO of BioNTech, the co-developer of the Pfizer vaccine, confirmed this by saying, “We must be aware that even triple-vaccinated are likely to transmit the disease. ... It is obvious we are far from 95% effectiveness that we obtained against the initial virus.”

The FDA’s decision will force monoclonal antibody treatment facilities around the country to close their doors to those seeking treatment for COVID-19 other than the mRNA vaccine.

In Florida, monoclonal antibodies proved to be a vital lifeline in the state’s approach to combatting COVID-19. Officials from the state of Florida condemned the FDA’s decision, claiming it was made without any warning and determined through analyzing clinical data not made available to the public.

After @HHSGov avoided communication with @HealthyFla regarding statewide allocations, without any warning, @US_FDA suspended the use of multiple MABs treatments. Such decisions should be made based on clinical data - which the FDA has not provided.pic.twitter.com/zpWl7ZGODQ
— Joseph A. Ladapo, MD, PhD (@Joseph A. Ladapo, MD, PhD) 1643065270

The Florida Department of Health issued a statement countering the FDA. In it, the state’s Department of Health lamented being forced to shut down state-run monoclonal antibody treatment sites, stating, “Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical data.”

As a result of the @US_FDA's abrupt decision to remove the EUAs for two monoclonal antibodies, monoclonal antibody treatment sites will be closed until further notice. Full press release is below.pic.twitter.com/RGeWTPwxCs
— Florida Dept. of Health (@Florida Dept. of Health) 1643080563