The U.S. Food and Drug Administration (FDA) has altered its guidance for the Wuhan coronavirus (Covid-19) "vaccine" from Janssen (Johnson & Johnson), which the federal agency now admits causes blood clots.
An FDA news release explains that the Janssen injection now has limited authorized use in individuals 18 years of age and older due to 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."
In other words, after a person gets injected with Janssen, potentially life-threatening blood clots could develop in a time period as short as one week. Even so, the FDA claims that the Janssen shot's "benefits" outweigh the risks, and that people should still line up to get it.
The "Fact Sheet for Healthcare Providers Administering Vaccine" now reflects the FDA's authorized use revision for Janssen. It includes a warning at the beginning summarizing the risk of TTS, as well as a revision concerning the risk of blood clots with low levels of blood platelets added to the "Fact Sheet for Recipients and Caregivers."
"We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
"Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals."
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Marks went on to boast about how the FDA's revisions somehow demonstrate that the federal agency is committed to maintaining robust safety and surveillance systems and "ensuring that science and data guide our decisions."
"We've been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA," Marks added.
"The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information."
Last April, the Centre territorial d'Information indépendante et d'Avis pharmaceutiques (CTIAP), an independent drug assessment center based in France, advised that all covid injections, not just Janssen's, be pulled from the market due to safety risks.
Two months prior to that is when the FDA and the U.S. Centers for Disease Control and Prevention (CDC) together announced that the Janssen shot specifically would be "paused" pending an investigation into six reported cases of TTS associated with the injection.
Right around the time that CTIAP advised that all shots, including Janssen, be pulled from the market, the FDA and the CDC lifted the pause and once again resumed administration of the Janssen injection.
The FDA still insists that the risk of TTS is "remote," and that getting the shot is worth it. The federal agency continues to push the Janssen injection on people who do not want the other mRNA (messenger RNA) injections that most people are receiving.
"The FDA has a robust safety surveillance system in place to monitor the safety of COVID-19 vaccines approved and authorized for emergency use," the FDA further announced.
"The FDA is monitoring COVID-19 vaccine safety through both passive and active safety surveillance systems in collaboration with the CDC, the Centers for Medicare and Medicaid Services, the Department of Veterans Affairs and other academic and large non-government healthcare data systems."
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