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CDC, FDA Respond to Florida Surgeon General’s COVID-19 Vaccine Safety Alert
epoch times ^ | 14 March A.D. 2023 | Zachery Steiber

Posted on 03/14/2023 5:46:30 AM PDT by lightman

U.S. health authorities have responded to the warning from Florida’s surgeon general about a spike in reports of adverse events following COVID-19 vaccination.

Drs. Rochelle Walensky and Robert Califf claimed in the response that Dr. Joseph Ladapo, the surgeon general, was misleading the public by focusing on the increase in adverse events reported to the Vaccine Adverse Event Reporting System (VAERS).

“The claim that the increase of VAERS reports of life-threatening conditions reported from Florida and elsewhere represents an increase of risk caused by the COVID-19 vaccines is incorrect, misleading, and could be harmful to the American public,” Walensky and Califf said in the missive.

Walensky heads the U.S. Centers for Disease Control and Prevention (CDC). Califf heads of the U.S. Food and Drug Administration (FDA). The CDC and FDA co-manage VAERS, which accepts reports from anybody but which is primarily used by healthcare workers.

The COVID-19 vaccines were given emergency authorization in late 2020. Under the emergency authorizations, vaccine companies and healthcare workers are required to report certain adverse events through VAERS, “so more reports should be expected,” Walensky and Califf said.

“Most reports do not represent adverse events caused by the vaccine and instead represent a preexisting condition that preceded vaccination or an underlying medical condition that precipitated the event,” they said.

They did not cite any studies or other research to support the claim.

While anyone can lodge reports with the system, authorities request medical records and other documentation in an effort to verify reports of certain events. Out of 1,826 reports of heart inflammation after Pfizer or Moderna vaccination in adults through May 26, 2022, for instance, the CDC verified 72 percent.

The CDC also identified hundreds of safety signals for the Moderna and Pfizer COVID-19 vaccines through analyzing VAERS data in 2022, according to records obtained by The Epoch Times. A safety signal is a possible sign of a side effect. Only a handful of adverse events are definitely caused by the vaccines, according to the CDC, including myocarditis, or heart inflammation, and severe allergic shock.

Ladapo said in February that in Florida, the number of reports to VAERS after the COVID-19 vaccines were authorized spiked by 1,700 percent, while the increase in vaccine administration rose by just 400 percent.

“We have never seen this type of response following previous mass vaccination efforts pushed by the federal government,” Ladapo said in a letter to Walensky and Califf.

“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 COVID-19 vaccines,” he added, calling for “unbiased research … to better understand these vaccines’ short- and long-term effects.” The Pfizer and Moderna vaccines both use messenger RNA (mRNA) technology.

Florida officials pointed to a study that found in the original clinical trials that the vaccinated were more at risk of serious adverse events, as well as other papers that found an increased risk of adverse events after COVID-19 vaccination.

Florida currently recommends against COVID-19 vaccination for young, healthy males who have been shown to be at the highest risk of myocarditis. Vaccinating the population “doesn’t make any sense” from a risk-benefit standpoint, Ladapo, appointed by Republican Florida Gov. Ron DeSantis, told The Epoch Times. The heart inflammation causes serious problems and can even lead to death in some cases.

Officials Differ

Walensky and Califf, both appointed by Democrat President Joe Biden, told Ladapo that their reference information supports vaccinating virtually all people aged 6 months and older with not only a primary series of the COVID-19 vaccine, but boosters.

“Based on available information for the COVID-19 vaccines that are authorized or approved in the United States, the known and potential benefits of these vaccines clearly outweigh their known and potential risks,” they said. “Multiple well conducted, peer-reviewed, published studies and demonstrate that the risk of death, serious illness and hospitalization is higher for unvaccinated individuals for every age group.”

The officials cited studies from the CDC, including papers published by the agency’s quasi journal. According to the CDC, some papers published by the journal aren’t peer reviewed. All of the studies are shaped by agency officials to align with its messaging, which during the pandemic has been aggressively pro-vaccination, even as awareness of confirmed and possible side effects has grown.

The messaging was on display in the letter.

“As the leading public health official in state, you are likely aware that seniors in Florida are under-vaccinated, with just 29% of seniors having received an updated bivalent vaccine, compared to the national average of 41% coverage in seniors,” Walensky and Califf said. “It is the job of public health officials around the country to protect the lives of the populations they serve, particularly the vulnerable. Fueling vaccine hesitancy undermines this effort.”

The officials said that they “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,” the officials continued.

The letter came after the CDC’s recent risk-benefit assessment of the new, updated boosters was criticized by independent medical professionals for downplaying risks and exaggerating benefits.

The officials did not note that the FDA authorized, and the CDC recommended, the new vaccines absent any clinical trial data. More than half a year later, that data has still not been made available, prompting many doctors to forgo boosters. Recent CDC data indicates the vaccines provide poor protection against infection, that the shielding against severe illness quickly wanes, and that natural immunity is superior to vaccination.

Reaction

Walensky’s and Califf’s response to Ladapo featured citations to flawed studies, Dr. Harvey Risch, professor emeritus of epidemiology at the Yale School of Public Health, told The Epoch Times via email, “The CDC routinely conducts cross-sectional studies and inappropriately analyzes them as if they were case-control studies, which substantially overestimates their reported vaccine efficacy measures.

“In this letter, these doctors cherry pick studies and ignore, for example, reliable Public Health UK data showing the exact opposite of what they claim,” Risch said.

“As much as they claim that the VAERS data are not quantitatively useful, these data indeed show a major COVID-19 vaccine rollout-period mortality signal that cannot be ignored or handwaved away by the lack of a population reference. These agencies continuously proclaim their data monitoring of several other information sources, yet they have not been transparent with these data,” he added.

Risch noted that insurance data shows a jump in COVID-19 deaths after the vaccines were authorized and that, according to a recent survey, many Americans know of at least one person who has suffered an adverse event after vaccination.

“FDA and CDC have lost credibility with much of the American public, and accusing Dr. Ladapo of misinformation when they themselves are the official purveyor of misinformation is unconscionable,” Risch said.

Nikki Whiting, a spokeswoman for Ladapo, said that the surgeon general would be sending a response letter to the officials.

“The response from the federal government is just another redundant display of the same apathetic talking point of ‘safe and effective.’ Googling their fact sheets would have achieved the same result,” she told The Epoch Times in an email.

“While the Feds gaslight the American public, Florida pushes for the truth. Three inquiries remain unanswered: 1. Access to raw patient-level data to allow for unbiased research. 2. Adequate attention surrounding the risks detected by numerous researchers around the world. 3. Public transparency from the CDC, FDA, and Big Pharma.”


TOPICS: Culture/Society; Government; News/Current Events; US: Florida
KEYWORDS: bigpharma; covid; covid1984; fl; florida; ladapo; vaccine; walensky
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Florida Surgeon General Dr. Joseph Ladapo

1 posted on 03/14/2023 5:46:30 AM PDT by lightman
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To: lightman

Then the FEDS should have an HONEST DEBATE about it instead of just “its wrong”.


2 posted on 03/14/2023 5:54:43 AM PDT by silent majority rising
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To: lightman
“Based on available information for the COVID-19 vaccines that are authorized or approved in the United States, the known and potential benefits of these vaccines clearly outweigh their known and potential risks,” they said. “Multiple well conducted, peer-reviewed, published studies and demonstrate that the risk of death, serious illness and hospitalization is higher for unvaccinated individuals for every age group.”

Good, then Indict them for MURDER, Issue a Governors Warrant for immediate extradition and let them Make their case to a Jury of their peers with their very lives on the line.
3 posted on 03/14/2023 5:56:46 AM PDT by eyeamok (founded in cynicism, wrapped in sarcasm)
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To: lightman
Most reports do not represent adverse events caused by the vaccine and instead represent a preexisting condition that preceded vaccination or an underlying medical condition that precipitated the event.

You could claim virtually any death to be due to pre-existing conditions. E.g., Joe has a medical history of asthma. We gave Joe drug-X that severely restricted his breathing and he died. We'll list severe asthma as cause of death. This is called a lie.

4 posted on 03/14/2023 6:09:33 AM PDT by JesusIsLord
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To: eyeamok

“Based on available information for the COVID-19 vaccines that are authorized or approved in the United States, the known and potential benefits of these vaccines clearly outweigh their known and potential risks,” they said. “Multiple well conducted, peer-reviewed, published studies and demonstrate that the risk of death, serious illness and hospitalization is higher for unvaccinated individuals for every age group.”
___________________________________
Vile, demonically inspired lies spite out of the mouths of lizards.


5 posted on 03/14/2023 6:14:36 AM PDT by iontheball
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To: eyeamok
Under the emergency authorizations, vaccine companies and healthcare workers are required to report certain adverse
events through VAERS, “so more reports should be expected,” Walensky and Califf said.

Hunh?

So, by this logic, when you release young, convicted felons back into a population, expect crime to go up, but not
because there are more felons in the population.

The evidence for a rational Democratic/Communist mind eludes me.

6 posted on 03/14/2023 6:16:48 AM PDT by Thommas (The snout of the camel is already under the tent.)
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To: lightman

Not mentioned is that, in its own defense, CDC cited erudite comments by FR’s own gassy, missingmojo and DiscoDuck!


7 posted on 03/14/2023 6:27:35 AM PDT by one guy in new jersey
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To: lightman

It’s about time someone stood up to the evil clot shot pushers.


8 posted on 03/14/2023 6:28:45 AM PDT by azkathy (We the people are FED UP-pun intended)
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To: azkathy

The one you call Disco Duck, are you talking about dugwaydouche?


9 posted on 03/14/2023 6:35:16 AM PDT by wildcard_redneck (Biden will mess up the Ukraine worse than Afghanistan.)
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To: lightman; JulieRNR21; Travis McGee; AAABEST; kinganamort; katherineisgreat; floriduh voter; ...

Florida Freeper

I'm compiling a list of FReepers interested in Florida-related topics.
If you want to be added, please FReepMail me.

10 posted on 03/14/2023 6:35:58 AM PDT by Joe Brower ("Might we not live in a nobler dream than this?" -- John Ruskin)
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To: silent majority rising

Do you know what I would like to do to the CDC, NIH, FDA and WHO? Oh, and Biden? It wouldn’t be printable here on Free Republic. Period.


11 posted on 03/14/2023 6:36:55 AM PDT by JoJo354 (We need to get to work, Conservatives!)
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To: lightman
Funny they say this about VAERS
“Most reports do not represent adverse events caused by the vaccine and instead represent a preexisting condition that preceded vaccination or an underlying medical condition that precipitated the event,” they said. They did not cite any studies or other research to support the claim.

But when we said literally the same thing for all the statistical lies about covid deaths they claimed which showed most HAD AT LEAST 3 to 4 serious comorbidities, that was not an issue and we were told the comorbidities did not matter.

Lying, double talking, deceitful jerks!
12 posted on 03/14/2023 6:55:39 AM PDT by Skwor
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To: lightman

“They did not cite any studies or other research to support the claim.”

of course not ... fascists never have to prove any of their lies since the entire corporate propaganda media and corporate social media automatically clap like trained seals at whatever pronouncements are made by the fascists ..


13 posted on 03/14/2023 6:59:08 AM PDT by catnipman (In a post-covid world, ALL "science" is now political science: stolen elections have consequences)
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To: lightman

“Walensky and Califf, both appointed by Democrat President Joe Biden, told Ladapo that their reference information supports vaccinating virtually all people aged 6 months and older with not only a primary series of the COVID-19 vaccine, but boosters.”

Comment censored...#%<%#@#%***


14 posted on 03/14/2023 7:18:56 AM PDT by goodnesswins (The Chinese are teaching calculus to their 3rd graders wh to sile ours are trying to pick a pronoun.)
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To: lightman
“The claim that the increase of VAERS reports of life-threatening conditions reported from Florida and elsewhere represents an increase of risk caused by the COVID-19 vaccines is incorrect, misleading, and could be harmful to the American public,” Walensky and Califf said in the missive.

He calls it "the increase" of VAERs reports? Look going up 10% is an increase. Even doubling I might call an increase. Going up 10 times the norm is a spike or an explosion. What he calls "the increase" is an explosion many times over. Its 50 to 100 times the norm.

This is gaslighting B.S., the guy can't be that stupid.

15 posted on 03/14/2023 7:34:34 AM PDT by AndyTheBear
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To: Skwor

Preexisting conditions in those that use Vaccines somehow magically increased by 50 to 100 times the norm in 2021...everybody knows that.... /s


16 posted on 03/14/2023 7:57:39 AM PDT by AndyTheBear
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To: wildcard_redneck

“ The one you call Disco Duck, are you talking about dugwaydouche?”
I haven’t seen him or Dr_Gasbag around lately.


17 posted on 03/14/2023 8:09:37 AM PDT by wjcsux (RIP Rush Limbaugh 12 Jan 1951- 17 Feb 2021. We really miss you. 😢)
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To: AdmSmith; AnonymousConservative; Arthur Wildfire! March; Berosus; Bockscar; BraveMan; cardinal4; ...

18 posted on 03/14/2023 8:12:08 AM PDT by SunkenCiv (Imagine an imaginary menagerie manager imagining managing an imaginary menagerie.)
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To: AndyTheBear

When counting COVID deaths they completely ignored existing conditions. Every death was because of Covid.

When counting COVID Vaccine deaths, they attribute everything to pre-existing conditions. Every death was because of something else. i.e. “He had a bad heart. That’s why he keeled over when we gave him the shot.”


19 posted on 03/14/2023 8:14:19 AM PDT by MMusson
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To: lightman

The burden of proof that the vac works and is safe is on the CDC pushing the vax, under both law and sound medical practice.

The CDC nonetheless is taking the position that people have to disprove efficacy and safety. Not the way science or the law works.


20 posted on 03/14/2023 8:15:28 AM PDT by Jewbacca (The residents of Iroquois territory may not determine whether Jews may live in Jerusalem.)
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