SAFE AND EFFECTIVE: FDA Dramatically Limits Use Of J&J Vaccine Due To Blood Clot Risk

Written by K. Walker on May 6, 2022

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The government is finally admitting that there are risks from the COVID jabs.

It’s something that they’ve been reluctant to admit despite tens of thousands of reported adverse reactions and even when they do report them, they insist that the vaccines are “safe and effective.”

But they’re clearly not working the way that a traditional vaccine works because it doesn’t prevent contracting or spreading the infection.

The U.S. Food and Drug Administration made the announcement on Thursday that the Janssen COVID-19 vaccine made by Johnson & Johnson would be limited to “certain individuals.” By “certain individuals” they mean those 18+ who cannot or refuse to get the mRNA shots developed by Pfizer or Moderna.

Politico reports:

The decision comes after the agency completed an updated risk analysis of developing thrombosis with thrombocytopenia syndrome, or TTS, a rare and possibly fatal combination of blood clots and low platelet counts one to two weeks after receiving the vaccine, the agency said Thursday.

Given the severity and urgency of the syndrome, and the availability of other Covid-19 vaccines, FDA decided that the benefits of Covid-19 protection from the Johnson & Johnson vaccine outweigh the risk of TTS only for those who cannot or will not receive other forms of vaccination…

…Johnson & Johnson said in a statement it will continue to work with regulators worldwide to ensure consumers “are warned and fully informed about reports of TTS.”

“The Johnson & Johnson COVID-19 vaccine plays a crucial role in the global fight to end the COVID-19 pandemic,” J&J said. “The Company continues to focus its efforts on ensuring its vaccine is available during the pandemic where people are most in need.”

The FDA published a few key points in the statement released Thursday:

  • After conducting an updated analysis, evaluation and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 Vaccine, warrants limiting the authorized use of the vaccine.
  • The FDA has determined that the known and potential benefits of the vaccine for the prevention of COVID-19 outweigh the known and potential risks for individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and for individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.

The move comes after updated numbers reported through the Vaccine Adverse Event Reporting System (VAERS) through March 18 showed that 60 people developed TTS after receiving the Johnson & Johnson shot, nine of whom died.

While the rate of TTS reported to VAERS didn’t increase from what was reported prior to March 18, the FDA said in December that of those cases, 15% of post-J&J jab TTS cases were fatal.

Neither the FDA nor the CDC have been able to determine risk factors for developing TTS, but the highest report rates are among women between the ages of 30-49.

The Janssen vaccine has only been received “emergency use authorization” through the FDA and this move may make full approval more difficult but not impossible. The FDA may approve the Janssen shot with along with restrictions or monitoring requirements, or may task Johnson & Johnson to identify the subpopulations that are at higher risk for blood clots.

While the CDC’s independent vaccine advisory panel made a preferential recommendation of the mRNA vaccines over the J&J product in December, FDA’s update essentially enshrined that preference on the vaccine’s label.

An administration official granted anonymity to discuss the FDA action noted that if mRNA vaccines did not exist, the J&J risk benefit profile would justify having it on the market. FDA’s emergency use authorization standard lets the agency allow expedient marketing of medical treatments when “there are no adequate, approved, and available alternatives” during a public health emergency.

“If there were no mRNA vaccines available, this is still a very viable option. It can save lives,” the administration official said. “But in places where there is an abundance of mRNA vaccines, like the U.S., the benefit risk profile changes because there’s other options. I think you have to look globally where there is not.”
Source: Politico

The FDA is advising people to choose the Pfizer or Moderna vaccines before opting for the J&J.

The entire premise of informed consent is that patients should know the risks before a medication or treatment is given. That hasn’t happened with these “vaccines” and now we’re seeing some pretty unsettling risks.

The group that is identitfied in Politico as the group most likely to develop blood clots are women between the ages of 30-49 who are also at low risk for severe complications and death from COVID.

Now that millions of people that have had COVID and recovered and had one, two, three, or four shots, they’re still pushing the mRNA vaccines that appear to be far less effective than what was reported.

At what point does this end?

The answer is when the fearmongering ends.

It’s no secret that people are cowering with fear these days. But those of us with faith know that living your life in fear is crap. Let’s get that message out there.

We’re living in a time where fear is running rampant and unchecked.

It seems like most public policy is based on fear these days, especially when it comes to the Wuhan Virus.

2 Timothy 1:7 says, “God has not given us a spirit of fear, but of power and of love and of a sound mind.”

It seems that a LOT of people have completely forgotten that message.

Let’s give them a reminder…

ClashDaily's Associate Editor since August 2016. Self-described political junkie, anti-Third Wave Feminist, and a nightmare to the 'intersectional' crowd. Mrs. Walker has taken a stand against 'white privilege' education in public schools. She's also an amateur Playwright, former Drama teacher, and staunch defender of the Oxford comma. Follow her humble musings on Twitter: @TheMrsKnowItAll and on Gettr @KarenWalker