FDA Limits Use of Johnson & Johnson COVID Vaccine Due to Blood Clot Risks

The FDA announced on May 5 that it is limiting the use of Johnson & Johnson’s Janssen COVID-19 Vaccine, citing a risk of individuals developing thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine. The FDA recognized the risk of blood clots due to TTS only a few months after the vaccine received emergency use authorization. The numbers have not dropped since, with 3.23 cases per one million doses and 0.48 deaths due to TTS per one million doses. 

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TTS: A Cause for Concern

TTS is a rare but very serious and potentially deadly syndrome resulting in blood clots and low blood platelets. Although uncommon, increasing numbers of TTS have been reported associated with vaccine administration of the Johnson & Johnson vaccine and the AstraZeneca vaccine. 

According to the Melbourne Vaccine Education Centre, TTS can result in blood clots in uncommon locations like the brain or gut or more common locations like the legs or lungs. Blood clots located in uncommon areas are more likely to result in severe cases and higher mortality rates. 

Still An Alternative for mRNA Vaccines

According to the FDA’s press release, individuals who fall under the following categories may still be able to receive the Johnson & Johnson vaccine.

• Individuals who received an mRNA COVID-19 vaccine and experienced an anaphylactic reaction.
• Individuals who would not otherwise receive a vaccine due to personal concerns receiving mRNA vaccines.
• Individuals with limited access to mRNA vaccines and would not otherwise receive a vaccine. 

Both the FDA and Johnson & Johnson have released updated fact sheets expressing the risk of TTS associated with the vaccine. 

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The Single-Jab Vaccine’s Beginnings

In response to the global pandemic, Johnson & Johnson’s COVID-19 Vaccine received emergency use authorization (EUA) on February 27, 2021. Only a few months later, on April 13, 2021, after 6.8 million doses were administered, the CDC and FDA jointly recommended a pause in the dispersal of the vaccine due to concerns in reports of six TTS cases. 

Despite the raging pandemic, the FDA took the first six reported cases very seriously because of TTS’s risk of long-term, debilitating health risks, rapid deterioration of patients, and high death rate. Just ten days after the pause was administered, it was lifted on April 23, citing that the potential benefits outweigh the risks at the time of the pandemic when the United States saw over 50,000 COVID-19 cases per day.

The FDA has monitored the risks of the vaccine since then, and over a year later, enough questions remained unanswered that the agency decided to restrict the use of Johnson & Johnson’s vaccine officially. 

Along with the risks that come after being diagnosed with TTS, the FDA stated that a significant cause for concern is that the reason some individuals may be at risk for developing TTS after receiving the vaccine is still unknown. 

Author

Reed Slater