The Centers for Disease Control and Prevention (CDC) along with the U.S. Food and Drug Administration (FDA) have lifted the pause on the Johnson & Johnson Janssen COVID-19 vaccine.
The CDC Advisory Committee on Immunization Practices (ACIP) voted on April 23 to recommend lifting the pause on the vaccine, which was previously put on hold on April 13. The committee, consisting of 15 medical professionals, passed the recommendation with a 10-4 vote, with one abstention, concluding that the benefits of the Johnson & Johnson COVID-19 vaccine outweigh the risks.
Upon its recommendation, the ACIP suggested adding a federal label about an “exceedingly uncommon, but potentially dangerous, blood clotting disorder” to warn citizens while giving them the choice on whether or not to receive the vaccine.
During the CDC ACIP presentation on April 23, a CDC scientist presented nine new confirmed cases of the rare disorder, bringing the total to 15 cases exclusively in women. Of the 15 cases, 13 have been in those between the age of 18-49-years-old; two have been in those ages 50 years and older.
“These cases are not just numbers to any of us, and we take them very seriously,” said Joanne Waldstreicher, chief medical officer at Johnson & Johnson, during the meeting. “These are people.”
Tom Shimabukuro, the deputy director of the CDC’s immunization safety office, attended the meeting and stated that the clotting disorder is “rare but clinically serious.”
According to the statement from both the CDC and FDA, “medical and scientific teams at the FDA and CDC examined available data during the pause to assess the risk of thrombosis involving the cerebral venous sinuses, or CVST (large blood vessels in the brain), and other sites in the body (including but not limited to the large blood vessels of the abdomen and the veins of the legs) along with thrombocytopenia, or low blood platelet counts.
“[Both teams] also conducted extensive outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events and could properly manage and recognize these events due to the unique treatment required for these blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS).”
“At this time,” the statement said. “The available data suggest that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.”
Rochelle Walensky, director of the CDC, reiterated that health and safety is at the forefront of all CDC decisions.
“Our vaccine safety systems are working,” Walensky said. “We identified exceptionally rare events – out of millions of doses of the Janssen COVID-19 administered – and we paused to examine them more carefully. As we always do, we will continue to watch all signals closely as more Americans are vaccinated.”
