Tag: fda

CDC, FDA Respond to Florida Surgeon General’s COVID-19 Vaccine Safety Alert

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.

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FDA Reveals Rare, Possibly Fatal Neurological Disorder Is A “Potential Risk” With New Pfizer Vaccine

People around the globe have suffered serious adverse reactions resulting from COVID vaccines, especially from the Pfizer shot.

Now the Food and Drug Administration (FDA) tells us another Pfizer vaccine can cause serious complications in recipients. After receiving Pfizer’s Respiratory Syncytial Virus (RSV) shot during a clinical trial, two older individuals contracted Guillain-Barré syndrome.

This was enough for the FDA to flag the disease as “an important potential risk” from the RSV shot. Yet Pfizer is still seeking approval for general public use.

According to the Mayo Clinic, Guillain-Barré syndrome is a rare disorder in which your body’s immune system attacks your nerves.

While most people recover from Guillain-Barre syndrome, some severe cases can be fatal. Other serious cases can result in paralysis.

There’s no known cure for Guillain-Barre syndrome.

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FDA Will No Longer Require Animal Tests Before Human Trials for All Drugs

Animal testing will no longer be a mandated part of the Food and Drug Administration’s approval process for all new drugs. Since 1938, pharmaceutical makers seeking FDA approval have had to successfully put their medications through multiple animals trials before proceeding to human tests.

Now, though, drug companies will have the option of either animal or non-animal tests—in a shift that animal rights groups and some pharma companies have long advocated for. Meanwhile, researchers’ reactions are mixed: Some say the move is unlikely to trigger immediate change, others are excited by the possibilities, while others still have safety concerns.

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FDA vaccine advisers ‘disappointed’ and ‘angry’ that early data about new Covid-19 booster shot wasn’t presented for review last year


Some vaccine advisers to the federal government say they’re “disappointed” and “angry” that government scientists and the pharmaceutical company Moderna didn’t present a set of infection data on the company’s new Covid-19 booster during meetings last year when the advisers discussed whether the shot should be authorized and made available to the public.

That data suggested the possibility that the updated booster might not be any more effective at preventing Covid-19 infections than the original shots.

The data was early and had many limitations, but several advisers told CNN that they were concerned about a lack of transparency.

US taxpayers spent nearly $5 billion on the new booster, which has been given to more than 48.2 million people in the US.

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Babies put at risk, even killed, in ‘reputable’ studies over the years

Public health officials and other medical professionals have helped untold millions over the years. But the hard truth is that some have hurt many.

This was a difficult lesson I learned many times when I was assigned to investigate FDA, CDC, NIH and pharmaceutical industry scandals at CBS News.

One of the most heartbreaking early stories I investigated in 2000 was the death of a baby who was given an experimental heartburn drug called Propulsid as part of a study. His death had been ruled a mysterious SIDS (Sudden Infant Death Syndrome) death.

Little Gage Stevens’ parents didn’t know that the drug he took, Propulsid, had been linked to dozens of deaths, including at least one other baby, before Gage even got his first dose. Shortly after Gage died, Propulsid was pulled from the market — linked to more than 300 deaths.

Read the death certificate on Gage.

My investigation revealed that the study consent form falsely stated Propulsid, made by Johnson and Johnson, was “approved by the FDA” for children. In fact, the Food and Drug Administration had repeatedly rejected it for pediatric use.

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FDA Says Ivermectin Doesn’t Work Against COVID-19 But Points To Studies That Show It Does

The U.S. Food and Drug Administration (FDA) says a drug called ivermectin does not work against COVID-19 but links to studies that show it does, an Epoch Times review has found.

The FDA’s website states, “Currently available data do not show ivermectin is effective against COVID-19.”

But half of the studies to which the FDA points support using ivermectin against COVID-19, according to the review.

The papers cut against the drug agency’s repeated exhortations for people not to take ivermectin for COVID-19. In Twitter posts, public statements, and emails, FDA officials have repeatedly warned against ivermectin. Some of those statements triggered a lawsuit from doctors who say the agency’s role is to approve drugs, not to issue recommendations. The suit was dismissed this week.

Dr. Pierre Kory, who frequently prescribes ivermectin for COVID-19 and co-authored a meta-analysis that concluded the drug is effective against the illness, told The Epoch Times that the government’s position on ivermectin “is one of the most glaring examples of the corruption of modern evidence based medicine.”

“There’s one message they want everyone to understand. And that message is that ivermectin doesn’t work,” Kory said. “That’s not a scientific conclusion, that’s theirs. That’s their perverted and distorted interpretation of the data.”

The FDA’s media office did not respond to a request for comment.

Dr. Janet Woodcock, a top official at the agency who was its commissioner from January 2021 to February 2022, told The Epoch Times via email that “ivermectin has been shown to be ineffective against COVID in large randomized trials.”

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FDA approves unpopular bivalent Covid shot for BABIES and ‘encourages parents to get their child vaccinated before the holidays’

US health officials today approved Pfizer and Moderna‘s bivalent Covid vaccines for babies, in a move bound to draw criticism.

The Food and Drug Administration (FDA) has green-lit plans for the updated shots to be given as part of a three-dose course for children aged six months to four years.

Agency officials said they ‘encourage parents and caregivers’ to get their child vaccinated ‘especially as we head into the holidays and winter months’.

It comes after a study found the bivalent vaccines are significantly weaker against a rising Covid variant expected to become dominant in the US in months.

Pre-school-aged children were already allowed to receive three extra-small doses of Pfizer’s original Covid vaccine, instead of the standard two-dose regimen for adults.

The move will see them given the Omicron-specific booster – made by either Pfizer of Moderna – as their third and final shot.

Officials recommend the children to receive the bivalent shot from the same brand they received their first two vaccine shots from.

So a child who receive the Pfizer vaccine for their first two doses should get the Pfizer bivalent shot as well. 

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FDA social media posts on COVID under legal, medical scrutiny for misleading claims

The FDA’s Twitter habits are getting scrutiny in court and from medical professionals as the feds seesaw between walking back their once-confident COVID-19 assertions and making sweeping new claims without providing evidence.

Having long ago conceded that COVID vaccines can’t stop viral transmission and that assertions to the contrary by President Biden among others were based on “hope” rather than science, the feds are now downplaying the influence of their social media to escape liability for allegedly violating statutory limits by interfering in medical judgments.

At the same time, over the past two months, FDA Commissioner Robert Califf has gone on a spree of evidence-free tweets about bivalent boosters and oral antivirals, such as Pfizer’s rebound infection-prone Paxlovid, prompting exasperation from leading doctors.

The FDA’s “social media statements … are what bother me the most,” U.S. District Judge Jeffrey Brown said in a hearing this month on the government’s motion to dismiss a lawsuit by three doctors who claim the agency’s false portrayals of ivermectin have harmed their ability to treat patients and threatened their licenses.

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FDA Says Telling People Not to Take Ivermectin for COVID-19 Was Just a Recommendation

The U.S. Food and Drug Administration (FDA) telling people to “stop” taking ivermectin for COVID-19 was informal and just a recommendation, government lawyers argued during a recent hearing.

“The cited statements were not directives. They were not mandatory. They were recommendations. They said what parties should do. They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin,” Isaac Belfer, one of the lawyers, told the court during the Nov. 1 hearing in federal court in Texas.

“They use informal language, that is true,” he also said, adding that, “it’s conversational but not mandatory.”

The hearing was held in a case brought by three doctors who say the FDA illegally interfered with their ability to prescribe medicine to their patients when it issued statements on ivermectin, an anti-parasitic that has shown positive results in some trials against COVID-19.

Ivermectin is approved by the FDA but not for COVID-19. Drugs are commonly used for non-approved purposes in the United States; the practice is known as off-label treatment.

The FDA created a webpage in 2021 titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” and later posted a link to the page on Twitter while writing: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” A second post stated: “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”

In a separate page, the FDA said: “Q: Should I take ivermectin to prevent or treat COVID-19? A: No.”

Those actions interfered with the doctors’ practice of medicine, violating the laws including the Federal Food, Drug, and Cosmetic Act, the lawsuit alleges.

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FDA Announces LAB GROWN MEAT That Was Served at COP27 Climate Conference Is ‘SAFE TO EAT’: ‘The World Is Experiencing A Food Revolution’

The US Food and Drug Administration has approved lab-grown meat, a product grown from animal cells, for human consumption for the first time.

The FDA announced Wednesday that laboratory-grown chicken developed by Upside Food, is “safe to eat,” clearing the way for the California-based company that creates cell-cultured chickens to begin selling its products.

To manufacture its meat, Upside Foods harvests cells from live animals, chicken tissue, and uses the cells to grow meat in stainless-steel tanks known as bioreactors.

The agency issued a statement Wednesday announcing it evaluated Upside Food’s production and cultured cell material and has “no further questions” about the safety of its cultivated chicken filet.

“The world is experiencing a food revolution,” stated FDA Commissioner Robert M. Califf. “Advancements in cell culture technology are enabling food developers to use animal cells obtained from livestock poultry, and seafood in the production of food with these products expected to be ready for the US market in the near future.”

“The FDA’s goal is to support innovation in food technologies while always maintaining as our first priority the safety of the foods available to US consumers,” he added.

Upside Foods founder and CEO Uma Valeti heralded the FDA’s approval.

“I’ve been looking forward to this day for a long time. UPSIDE has received our “No Question Letter” from the FDA. They’ve accepted our conclusion that cultivated chicken is safe to eat, meaning UPSIDE is one step closer to being on tables,” Valeti tweeted.

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