Wednesday, Aug 10, 2022

Florida Rejects Covid-19 Vaccines For Babies, Preschoolers

 

Gov. DeSantis Clashes With White House Again

 

Florida’s Governor Ron DeSantis is bucking the establishment again, this time in rejecting the advice of the CDC and FDA who, one week ago, unanimously endorsed the Pfizer and Moderna shots for babies and children under 5.

This clears the way for some 20 million babies and preschoolers to be eligible for the vaccines, a scenario that raises concern for many over reports of inadequate studies of vaccine safety data, particularly with regard to young children.

As some states moved to pre-order the vaccine for children under 5, DeSantis confirmed Florida was not among them, the Miami Herald reported. The Sunshine State would not be ordering Covid-19 vaccines for Florida’s youngest population, the governor told reporters at a Miami press conference.

“There are not going to be any state programs that are going to be trying to get Covid jabs to infants, toddlers, and newborns,” Desantis said. “That’s not something that we think is appropriate, so that is not where we are going to be utilizing our resources.”

A White House statement last week echoed an FDA announcement that Moderna’s two-dose shot and Pfizer’s three-dose shot are “safe, effective and beneficial” for children as young as 6 months. The approval fast tracks the vaccine for distribution and children could start receiving shots as soon as this week.

But DeSantis said the trial data on the vaccines is “abysmal,” and the vaccines have not been through enough testing to ensure they are safe for use in children, a local Florida news station reported.

The governor’s position drew scathing criticism from the White House for rejecting “the science” as espoused by the Biden Administration and for “abandoning Florida’s children.”

But DeSantis pushed back, citing studies that show that infants and toddlers “are at practically zero risk of contracting anything serious with Covid.”

“Our Department of Health has been very clear,” he said. “The risk outweighs the benefits, so the state will recommend against getting those kids vaccinated.”

“That’s not the same as banning it,” the governor clarified. “Florida will not ban the vaccine, but it also will not accept free supplies of the vaccine from the federal government or take steps to promote or distribute them. People can access it if they want to, they are free to choose.”

United States An Outlier In Vaccinating Infants

President Joe Biden celebrated the decision to endorse vaccines for kids, and similar sentiments were echoed by White House Chief of Staff Ron Klain, who emphasized how America would be “the first country on earth to give mRNA vaccines to its youngest children.”

Addressing a question about how he reconciled his position with that of the White House, DeSantis said that the United States is an outlier on the subject of giving Covid vaccines to young children, especially with regard to infants, and that no other country has taken this path.

“There’s nothing wrong with being the ‘lone ranger’ if you’re right,” the Republican governor said. “But other countries in Europe are going a different direction, similar to Florida. They have been right on Covid way more than Dr. Fauci and his crew, throughout this whole thing.”

Germany and France, along with Denmark, Finland, Sweden, and Norway, have restricted the distribution of the Moderna Covid shots for individuals under the age of 30, citing the documented risk of heart inflammation among young people as justification.

Florida has also taken similar actions, with the state’s Department of Health becoming the first in the nation to recommend against the use of Covid shots for children back in March, reports The Federalist.

DeSantis told reporters that parents don’t have any reason to worry about their kids getting infected with Covid-19. He said that the FDA board made its decision to pacify parent’s fears about the virus, fears that have been relentlessly stoked by the media.

“To do an emergency-use authorization for a six month-old or a one year-old simply to placate anxiety, that’s not the standard when injecting mRNA,” Florida’s governor said.

Repeated Clashes

DeSantis has repeatedly clashed with the White House over pandemic measures during the past two years, consistently opposing Covid masking mandates and widespread lockdowns. His administration made it a priority to keep Florida’s children in school and businesses open.

He made it illegal for schools and workplaces to force employees to vaccinate as a condition of employment, and to force children to wear masks. Most recently, DeSantis threatened the Special Olympics to drop its Covid-19 vaccine mandate or otherwise face a $27.5 million fine.

“This got him called a murderer by many national pundits and politicians. Yet his approach was vindicated,” asserted a NY Post op-ed. “Despite predictions of doom, the Sunshine State did much better than lockdown-heavy states like California and New York, not only in terms of disease, but also economically.”

Then, in March, Florida became the first state to officially recommend against the Covid-19 vaccines for healthy children ages five and older.

Condemnation came fast and furious. The American Academy of Pediatrics called the recommendation “irresponsible.” The Infectious Diseases Society of America accused Florida Surgeon General Dr. Ladapo of putting “politics over the health and safety of children.”

Florida’s Surgeon General Complains of ‘Blatantly False Statements’

Far from cowed by the backlash, Dr. Ladapo, in a letter to the chairman of the House Subcommittee on the Coronavirus Crisis, took the federal government to task for its pediatric guidance on Covid-19 vaccines.

Ladapo slammed the subcommittee for putting forth “blatantly false statements” about vaccine safety. He also challenged federal guidance recommending children 6 months through 5 years of age receive a Covid-19 vaccine.

In the letter, he challenged Dr. Anthony Fauci’s claim that side-effects resulting from Covid-19 vaccines are “no better or worse” than those resulting from “any of a number of childhood vaccines.” Ladapo pointed to clinical studies underscoring the risk of adolescents, especially young men, contracting myocarditis or pericarditis after getting dosed with a Covid vaccine.

Scientists at Emory, Vanderbilt and Duke recently concluded the mRNA vaccine significantly increased the risk of potentially fatal heart damage in young men, reports the Federalist. Their findings clash with the CDC’s claim that only very limited incidents of myocarditis and pericarditis in adolescents have been recorded.

Additionally, wrote Dr. Ladapo, “There are no data that prove this vaccine is more effective than the placebo in reducing severe illness and other clinically meaningful outcomes in this age group.”

Ladapo admonished the members of the Senate subcommittee for misleading Americans, saying “it is unfortunate that the information you released is perpetuating confusion among the public.”

“To receive an Emergency Use Authorization (EUA), a manufacturer must show that a product ‘may be effective’ at preventing a disease, and the FDA must determine that the benefits outweigh the risks,” Ladapo stressed. “The vaccine manufacturers failed to meet this burden of proof, especially for those ages 6 months-4 years.”

Ladapo concluded with his assurance that “Florida remains committed to making recommendations and decisions based on data and science – not ideology.”

Fauci Admits Insufficient Data

The data used by the FDA and CDC in greenlighting the Covid vaccines for babies and very young children drew sharp criticism from other experts as well. Dr. Marty Makary, a surgeon and public policy researcher at Johns Hopkins University, voiced his concerns on social media.

“There was no statistical significance in the vaccine study cited by FDA & CDC to recommend the vax in babies through kids under 5,” Makary said. “Any respected medical journal would normally reject this study for publication. How does the CDC so vigorously recommend this?”

Makary later expanded upon his assessment in a recent Fox News op-ed, saying the studies cited by the federal government “were too small to achieve statistical significance when evaluating efficacy against Covid-19 infection.”

This was emphasized in a recent Senate subcommittee hearing as Dr. Fauci was being questioned by Sen. Rand Paul about the government’s recommendation for injecting children over five with a Covid vaccine. Paul wanted to know what scientific data supports this recommendation. Fauci admitted there was none.

SEN. RAND PAUL: Are you aware of any studies that show a reduction in hospitalization or death for children who take a booster?

FAUCI: Right now, there’s not enough data that has been accumulated to indicate that that’s the case.

RAND PAUL: So there are no studies. Americans should all know this: There are no studies on children showing a reduction in hospitalization or death with taking a booster.

Congressmen Demand Answers

Since the Covid-19 vaccine roll-outs began, the CDC has reportedly withheld data that it thought would contribute to vaccine hesitancy, and admitted that it did not monitor or analyze vaccine safety data, including cases reported to the Vaccine Adverse Event Reporting System (VAERS).

Eighteen members of Congress sent a letter to the FDA in June, calling for answers to a number of questions about the EAU that the FDA was expected to soon issue for Covid-19 vaccinations for children under age five, reported The Texan.

“We are in our third year with Covid-19, and we know vastly more about the virus now than we did in 2020. One of the most important things we know is that this virus poses minimal risk for children,” wrote Sen. Ted Cruz, R-TX, one of the letter’s signatories.

The group of legislators submitted 19 questions to FDA Commissioner Robert M. Califf, covering numerous concerns about the plan to vaccinate babies and preschoolers. One question asks why the FDA recently lowered the bar for Covid vaccines for young children to an efficacy threshold of less than 50 percent, whereas the previous EUA for ages 16 and older relied on data claiming 90 percent effectiveness.

While data from trials of Moderna’s two-dose vaccinations showed a 51 percent effectiveness in children aged 6 mos. -2 yrs, the rate dropped to 37 percent for 2-5 year-olds.

Why then are these non-efficacious vaccines being pushed on young children, the lawmakers want to know.

Other questions posed by the group referenced studies about cardiac risk factors resulting from the vaccines, and the possibility of increasing a child’s risk for future variants.

The legislators also asked about the possibility of vaccinated children developing “antibody dependent enhancement,” a condition being observed with increasing frequency that leaves a Covid patient more vulnerable to severe illness after an initial period of immunity.

Gaslighting by the CDC

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against Covid-19,” enthused CDC Director Rochelle Walensky last week. “We know millions of parents and caregivers are eager to get their young children vaccinated, and with today’s decision, they can.”

Walensky would later go on to claim during a press conference that Covid-19 has been one of the top five causes of death for children since the beginning of its outbreak, making her the third CDC official in recent weeks to make this assertion.

These statements fly in the face of studies that have shown that healthy children are at minimal risk of severe Covid-19 infection, morbidity and mortality.

As of June 2, 2022, for instance, 1 month old babies-to 17 year-olds comprised approximately 0.1 percent of the total Covid-related deaths in the United States.

“Recent studies conducted in Sweden and Germany have documented similar trends, with both analyses finding Covid fatalities among healthy children in each European country to be nearly nonexistent,” writes The Federalist.

These statistics are corroborated in painstaking detail by a report in Bioethics, Vol. 36, Issue 6. The report, found on the Wiley Online Library, cites, among a host of clinical trials and scientific papers, a large study in Germany that found no deaths among children aged 5–11 without comorbidities.

Overall, the article said, “the burden of Covid-19 in children appears to be similar to or lower than that of typical seasonal flu–unlike the much higher disease burden of Covid-19 in adults.”

In addition to children not being significant spreaders of the virus, research shows the majority of American children have already recovered from Covid and therefore possess immunity to reinfection. According to the CDC’s own data, approximately 75 percent of children in the United States have recovered from Covid.

An increasingly large body of evidence has shown that individuals previously infected with the virus possess robust natural immunity, equal to that of vaccine-induced immunity, and of longer duration.

Recent data from Israel as reported in MedRXiv, in conjunction with researchers at Yale and the British Medical Journal, support the position that long-lasting immunity following infection in children, especially in 5-11 year-olds, is the norm.

In view of these findings, health authorities in Norway no longer recommend vaccinating children aged 12–15 who have recovered from Covid-19, the Bioethics Report states.

*****

CDC Partners With Sesame St. To Entice Parents to Vaccinate Children

CDC’s Walenksy’s depiction of “eager parents” embracing the opportunity to vaccinate their children rings a bit hollow, in light of a report by the Kaiser Family Foundation that discusses possible reasons for the lack of parental enthusiasm about Covid vaccines for their children.

“The recent lull in Covid-19 cases, has reduced the sense of vaccination urgency,” the survey speculated. “And many parents also remain reluctant to vaccinate kids under 5, who face less risk of severe Covid-19 cases than older people.”

To counter this reluctance and entice parents and children to view vaccinating preschoolers in a favorable light, the CDC partnered with Sesame St. to produce skits dramatizing little 3-yr old Elmo bravely getting his Covid vaccine, so he can “help himself, his family and his neighborhood stay safe.”

Another scenario has a child being hailed as a hero by his grandmother for taking the shot—ostensibly helping to keep grandma “safe.”

From an ethics perspective, the device of using healthy children at minimal risk of Covid illness merely as a tool to keep others safe, is odious, critics say. At the very least, such a sacrifice “requires sufficiently large benefits to others and sufficiently small costs to children, which does not appear to hold true for Covid-19 vaccination,” Bioethics pointed out.

The report also noted that children have already been “disproportionately harmed” by school closures, masking and lockdowns, “all of which were primarily for the benefit of older and more vulnerable people.”

The article poses a sobering question: A great deal has been demanded of and given by our precious children. Should we really be asking them for more?

*****

British Drs. Say Pfizer’s Documentation on Children Full of Holes

A letter signed by 76 British physicians to the Medical and Healthcare Regulatory Agency (MHRA) and other government officials, petitioned the British government not to authorize Covid vaccinations in infants and young children, as the FDA has done.

“We would urge you to consider very carefully the move to vaccinate ever younger children against SARS-CoV-2,” the letter, made public this week, began. The authors cited the evidence of “rapidly waning vaccine efficacy, the increasing concerns over long-term vaccine injury, and the knowledge that the vast majority of children possess effective immunity” from previous Covid infection.

“Thus, the balance of benefit and risk which supported the rollout of mRNA vaccines to the elderly and vulnerable in 2021 is totally inappropriate for small children in 2022,” the letter argued.

‘Huge Gaps’

The authors went on to lay out what they described as “huge gaps in the evidence provided by the Pfizer documentation” purportedly attesting to the vaccine’s benefit and safety.

They pointed out that the protocol was changed mid-trial, when it became clear that the original two-dose protocol exhibited poor immunization effects. A third dose was then added in midstream, by which time there was no longer a control group, as those receiving a placebo had been vaccinated. This alone should have invalidated the study, the authors state.

In addition, according to the physicians who analyzed the Pfizer documents, “there was no statistically significant difference between the placebo and vaccinated children, in either the 6–23-month age group or the 2-4-year-olds, even after the third dose (italics added.)

Astonishingly, the results were based on just three participants in the younger age group, and just seven participants in the older 2–4-year-olds.

Pfizer itself stated that the numbers were too low to draw any confident conclusions.

The physicians’ letter to the government agency notes that the “additional immunogenicity studies against Omicron, requested by the FDA, only involved a total of 66 children tested one month after the third dose.”

“It is incomprehensible,” the authors wrote, “that the FDA considered that this represents sufficient evidence on which to base a decision to vaccinate healthy children.”

“When it comes to safety, the data are even thinner,” the letter notes: “Only 1,057 children were followed for just two months. It is noteworthy that Sweden and Norway are not recommending the vaccine for 5-11 year-olds, and Holland is not recommending it for children who have already had Covid-19.

“The director of the Danish Health and Medicines Authority stated recently that given what is now known, the decision to vaccinate children was a mistake,” the letter attests.

Risks of Myocarditis

The physicians revisit the evidence of increased risk of injury from Covid-19 vaccines for children, focusing on the concern about myocarditis. The letter cites “persistent cardiac abnormalities” in adolescents with post-mRNA myocarditis, as demonstrated by follow up MRIs at 3-8 months. This suggests this condition is far from ‘mild and short-lived,’ as claimed by the FDA and CDC.

In addition, the letter raised the issue of “vaccine-induced disruption” of the immune response, evidenced in various clinical studies. “The possibility of developing an impaired immune function would be understandably disastrous for children,” the authors noted.

The letter also airs concerns over complete omission of information explaining to the public the different and novel technology used in Covid-19 vaccines, which have been called “genetic modification therapy,” compared to standard vaccines.

“The failure to inform of the lack of any long-term safety data, borders on misinformation,” the authors write.

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