Johnson & Johnson Covid-19 Vaccine Use Limited By US Food And Drug Administration Advisory

Bruce Haring
·2 min read

The claims that Covid-19 vaccines are “safe and effective” now comes with a “But.”

The US Food and Drug Administration announced Thursday that the Johnson & Johnson/Janssen Covid-19 vaccine should only be used in emergencies. Its use is now intended only for people 18 and older for whom other vaccines aren’t appropriate or accessible, or for those whose only option is a J&J shot.

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The FDA said in a statement that the change is because of a risk of a clotting condition called thrombosis with thrombocytopenia syndrome (TTS) from use of the vaccine.

Thursday’s announcement is sure to fuel further concerns among those who have resisted Covid-19 vaccinations. Many people have cited concerns about vaccinations that were rushed to market without the usual years-long vetting on potential long-term effects. While those fears have been derided as “conspiracy theories,” today’s ruling will give pause on whether the resistance was grounded in logic.

“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,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “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. … Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our actions.”

The new marching orders applies to first shots and any boosters.

Despite the warning, the FDA said the J&J vaccine’s blood clotting problem is still better than not being vaccinated. It gave several examples of those who may still benefit, including: :

  • Those who had a severe allergic reaction to an mRNA vaccine, such as those from Pfizer/BioNTech or Moderna;

  • Those with personal concerns about the mRNA vaccines who would remain unvaccinated without the J&J vaccine;

  • Those with limited access to mRNA Covid-19 vaccines.

Moe than 18.7 million doses of the J&J vaccine have been administered in the US, according to the US Centers for Disease Control and Prevention. It estimated that 7.7% of those who received the J&J vaccine are considered fully vaccinated.

In an updated fact sheet on the vaccine, the FDA says that 15% of TTS cases have been fatal.

The agency’s updated analysis of the vaccine includes cases reported to its Vaccine Adverse Events Reporting System (VAERS) database through March 18. The FDA says it has confirmed 60 cases of TTS, including nine deaths.

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