(NewsGlobal.com)- Last week, the Food and Drug Administration announced that the emergency use authorization for the Johnson & Johnson/Janssen COVID vaccine would be limited to people 18 and older for whom the other vaccines are not an option.
In a statement released on Thursday, the FDA acknowledged that after receiving the Johnson & Johnson/Janssen vaccine, there is a risk of a rare clotting condition called thrombosis with thrombocytopenia syndrome (TTS).
And while there is a risk of TTS, the FDA believes that, for certain people, the benefits of receiving the Johnson & Johnson vaccine outweigh the risk. Those who can still receive the Johnson & Johnson vaccine include people who suffered a severe allergic reaction to the Modern or Pfizer mRNA vaccines, people with limited access to the mRNA vaccines, and those with concerns about the mRNA vaccines who would remain unvaccinated without the Johnson & Johnson vaccine.
As of last Thursday, over 18.7 million doses of the Johnson & Johnson vaccine have been administered in the United States.
In December, the CDC’s vaccine advisory committee issued an updated recommendation favoring mRNA vaccines over the Johnson & Johnson vaccine in those 18 and younger citing the same concern over the occurrence of TTS.
The FDA and CDC had previously recommended pausing the use of the Johnson & Johnson vaccine over the reports of TTS, but the pause was lifted.
According to the updated FDA fact sheet on the J&J vaccine, 15 percent of TTS cases can be fatal. Thus far, the FDA has confirmed 60 cases of TTS associated with the vaccine. Nine of those cases were fatal.
It is estimated that three out of every 1 million doses of the vaccine administered resulted in TTS. Women ages 30 to 49 have the highest rate of TTS, with about 8 cases per 1 million doses of the vaccine administered.
In most cases, the symptoms begin one to two weeks after vaccination. Those with TTS will suffer shortness of breath, chest pain, abdominal pain, leg swelling, headaches, blurred vision, and red spots extending beyond the site of injection.