The Food and Drug Administration is limiting who can get the Johnson & Johnson coronavirus vaccine over a rare but deadly blood clot risk.
The agency is limiting the single-dose shot to individuals who are unable or unwilling to take the Pfizer or Moderna vaccines.
Feds limit J&J shot over blood clot risk
The FDA and CDC briefly paused authorization for the J & J shot in April 2021 and issued a warning over a link between the vaccine and a dangerous, rare blood syndrome called thrombosis with thrombocytopenia syndrome, or TTS. The condition was unknown before the global COVID vaccination program.
A person with TTS develops potentially fatal blood clots and low platelet counts simultaneously. The symptoms usually occur one to two weeks after vaccination. The new disorder is still not understood clearly, but women aged 30 to 49 are at higher risk.
More than a year after the initial J & J pause, the FDA will only allow the shot for those 18 years and older who cannot take the Pfizer or Moderna shots for medical reasons or who otherwise would remain unvaccinated if they did not take the J & J shot.
An “updated analysis” of TTS cases in the Vaccine Adverse Event Reporting System (VAERS) had confirmed 60 cases of TTS, nine of them fatal, in individuals who took the J & J shot, the FDA said.
The FDA said it weighed several factors in its decision, including the fact that the risk factors for developing TTS are still unclear, the high death rate from TTS, the potential for individuals with TTS to “rapidly deteriorate,” and the risk of “long-term and debilitating health consequences.”
Safe and effective?
The news is sure to lead to greater skepticism of the COVID vaccines that have been repeatedly touted as “safe and effective” by the Biden administration, despite the risk of serious side effects like myocarditis.
The vaccines have failed spectacularly at blocking infection, but the Biden administration has continued to recommend boosters.
For months, Biden demonized Americans who declined to get vaccinated, declaring in a chilling September 2021 speech that patience with the refusers was “wearing thin,” and many Americans have been coerced into taking the shot against their will in order to keep their jobs. Many others have been fired.
In recent months, Biden has dialed down his rhetoric against “the unvaccinated,” and vaccine mandates for entering restaurants and public venues have been relaxed in most cities as Democrats look to ease restrictions before the midterms. But vaccine mandates remain in effect in roughly 4 in 10 workplaces.