(The Epoch Times)—The Food and Drug Administration is not adding “black box” warnings to COVID-19 vaccines, even though an agency center recommended it, FDA commissioner Dr. Marty Makary said on Dec. 15
“When it comes to the ‘black box’ warning, we have no plans to put that on the COVID vaccine,” Makary said during an appearance on Bloomberg Television.
Black box warnings are the highest safety-related warnings that FDA officials can place on products. Scenarios warranting their usage include when there is an adverse reaction so serious that it is “essential that it be considered in assessing the risks and benefits of using the drug” or when there is a serious adverse reaction that can be prevented or reduced by appropriate use of the drug, according to FDA documents.
The announcement comes several weeks after FDA officials reported deaths of children following COVID-19 vaccination and concluded that at least 10 deaths were related to the vaccines, according to a November memorandum obtained by The Epoch Times. The review, which included looking at autopsies, has been broadened to other age groups.
The announcement also came several months after regulators updated language on the vaccine labels for a form of heart inflammation called myocarditis. The inflammation was discovered after the FDA first authorized COVID-19 vaccines in December 2020. The updated labels state that the highest observed risk of myocarditis was among young males aged 12 to 24 after receipt of vaccines from Pfizer-BioNTech and Moderna.
Makary said Monday that an FDA safety and epidemiology center did recommend adding a black box warning to the COVID-19 vaccines, and indicated the recommendation stemmed from the risk of myocarditis.
But, he said, Dr. Vinay Prasad, the agency’s top vaccine official, and other FDA leaders opted against accepting the recommendation because the dosage people are receiving has changed from the original two doses within weeks or months of each other.
“When you have those two doses three months apart, that’s when you see the side effects go way up, like myocarditis in young people,” Makary said on Bloomberg. “Now that it’s annual, you may not see that same prevalence. So we don’t want to extrapolate findings to today if it’s not transferable.”
COVID-19 vaccines had been cleared and recommended for virtually all Americans until Trump administration officials took a series of steps to narrow the clearance and recommendations. They are now only advised on an annual basis after consulting with a health care professional and taking into account various factors, including whether people have characteristics such as obesity that could put them at higher risk of severe problems if they contract COVID-19.
Moderna and Pfizer have said their vaccines protect people and have favorable safety profiles, a position also held by some groups such as the American Academy of Pediatrics. The academy counts Pfizer and Moderna among its partners.
Other experts and advocates have called for the removal of COVID-19 vaccines.
Dr. Robert Redfield, former director of the Centers for Disease Control and Prevention, recently told The Epoch Times that clearance for them should be withdrawn because the spike protein they deliver is immunotoxic, and that he would not be surprised if, after the FDA finished its investigation, regulators placed a black box on the shots.
Quoting the FDA commissioner: “Now that it’s annual, you may not see that same prevalence.”
I see. “may not”….sorta’ like “cudda, wudda, shudda”. You “may not” see the same prevalence.
And then again, YOU MAY. We just don’t know, and we don’t want to scare anyone. Is that the best government money can buy, or what?
What all this boils down to, is that our own government still hasn’t learned that clot shots are toxic, despite the fact that people are dead because of it. How’s that make you feel? In addition to the towel-heads, our own government wants to kill us. Very nice, right? /sarc
“Black box warning” is the highest safety-related warnings FDA can put on products, but risking your life by getting a clot shot doesn’t rise to that level, apparently. Since they’re skipping the “black box warning”, that leaves room for a small Darwin Award logo. Maybe someone should suggest that.
Love the Darwin Award idea. Yes, the entire Covid jab was a Darwin Award!
Require these officials to take the boosters FOUR MONTHS apart. According to their own science, there’s no evidence anything other than 3 months apart is dangerous, right? If they refuse while simultaneously trying to sell that drivel, fire them.
Love the Darwin Award idea. Yes, the entire Covid jab was a Darwin Award!
Something is seriously wrong and EVIL here. The FDA violated its own principles just so you could get the deadly jab and we don’t know much about the spike proteins being released on humanity all over the world. So what is going on?
Don’t they ever stop to consider whether it was a bad thing to kill all those people? Apparently not. Instead, they’re going to keep selling it, and adamantly refuse to put a warning on the jab that might make some of them think twice about getting it injected into their body.
The highest levels do know. Satan hates all humankind and especially babies.
George Malthus began the softening of human reproduction with the “overpopulation” cycle myth.Then Mararet Sanger, demanding birth control pills. Then women’s liberation and get out of the home. Demanding equal pay because it’s not achievable as long as some women take time off to have babies, so keep it up ladies.
1st stop trusting anything medical, they are lying to you and we can only guess why.
2nd the covid shot has been shown to cause problems up to death, and it is not needed at all.
3rd The FDA is a controlled agency by the pharma companies and profit is the only thing, death is a side effect.
There is something very wrong with our gov. seems either communist (dems) or muslims are controlling most things and our system is falling apart. question everything and don’t take gov. info as truth, look elsewhere.
Good luck