The Food and Drug Administration (FDA) announced Thursday it is significantly limiting use of Johnson & Johnson’s COVID-19 vaccine due to a risk of rare but severe blood clots.
The agency announced it is limiting the single-shot vaccine’s authorization to individuals who are either unable to get one of the available mRNA vaccines from Pfizer and Moderna, either due to a lack of access or a medical issue, or to individuals who will not otherwise get vaccinated unless it is by the Johnson & Johnson shot.
The U.S. Food and Drug Administration (FDA) said on Thursday it was limiting the use of Johnson & Johnson’s COVID-19 vaccine for adults due to the risk of a rare blood clotting syndrome. https://t.co/SKywihMxsq
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The FDA briefly paused the use of Johnson & Johnson’s shot last year, due to reports that some recipients were developing thrombosis with thrombocytopenia syndrome (TTS). The pause was lifted within weeks, as it was determined only 15 individuals out of eight million vaccine recipients developed the syndrome.
Now, the FDA says it has completed an updated analysis and determined that the risk of TTS warrants limiting the use of the vaccine. The symptoms of TTS typically set in within one to two weeks after getting the shot, the agency reported. (RELATED: Poll: Most Parents Don’t Want To Vaccinate Their Young Children Against COVID Right Away)
Development of the clot still appears to be rare; as of March 18, there were just 60 reports of TTS out of more than 18 million Johnson & Johnson doses distributed, according to Politico. However, the FDA may be exercising caution due to the severity of the condition. Of the 60 TTS cases, nine of the individuals died.
Neither the FDA nor the Centers for Disease Control and Prevention (CDC) have determined what the risk factors for TTS after a Johnson & Johnson shot may be, but the cases have thus far been concentrated largely in women between ages 30 and 49.