On Friday, U.S. health officials lifted an 11-day pause on COVID-19 vaccinations using Johnson & Johnson’s single-dose shot, after scientific advisers decided its benefits outweigh a rare risk of a blood clot.
An emergency meeting was held by the Centers for Disease Control and Prevention to discuss additional cases of a rare blood clot found in people who received the Johnson & Johnson COVID-19 vaccine.
As of Wednesday, Dr. Tom Shimabukuro told Fox News that there were fifteen cases of thrombocytopenia syndrome that which includes a potentially deadly cerebral venous sinus thrombosis, deep vein thrombosis, and pulmonary thromboembolism, were found among 8 million vaccinations.
The government uncovered 15 vaccine recipients who developed a highly unusual kind of blood clot, out of nearly 8 million people given the J&J shot. All were women, most under age 50. Three died, and seven remain hospitalized.
But ultimately Friday, the Food and Drug Administration and Centers for Disease Control and Prevention decided that J&J’s one-and-done vaccine is critical to fighting the pandemic – and that the small clot risk could be handled with warnings to help younger women decide if they should use that shot or an alternative.
“Above all else, health and safety are at the forefront of our decisions,” CDC Director Dr. Rochelle Walensky said in a statement. “Our vaccine safety systems are working. We identified exceptionally rare events – out of millions of doses” of the J&J shot and will continue to monitor them.
The U.S. decision – similar to how European regulators are rolling out J&J’s shot – comes after CDC advisers earlier Friday voted 10-4 to resume vaccinations but panelists made clear that they must come with warnings about the risk. The group debated but ultimately steered clear of outright age restrictions.
“This is an age group that is most at risk (of the clotting) that is getting vaccine predominately to save other peoples’ lives and morbidity, not their own. And I think we have a responsibility to be certain that they know this,” said Dr. Sarah Long of Drexel University College of Medicine, who voted against the proposal because she felt it did not go far enough in warning women.
The committee members all agreed the J&J vaccine “should be put back into circulation,” panel Chairman Dr Jose Romero, Arkansas’ health secretary, said in an interview after the vote. “The difference was how you convey the risk … It does not absolve us from making sure that people who receive this vaccine, if they are in the risk group, that we inform them of that.”
Of those 15 cases, 12 were identified as CVST with thrombocytopenia.
All of the reported cases were found in women aged 18-59, but other potential cases found in men are under review.
Symptoms include chills, fever, severe headaches, and speech difficulty.
Six patients were treated with heparin, seven are hospitalized and five were discharged. Three patients died from TTS.
The CDC and FDA recommended temporarily pausing the distribution of Johnson & Johnson’s vaccine on April 13 after the rare blood clot was found in six women, ABC News reported.
Tom Shimabukuro with the CDC COVID-19 vaccine task force elaborated on cases of so-called thrombosis with thrombocytopenia syndrome (TTS) following J&J COVID-19 vaccinations. TTS is a broad term including the rare but potentially deadly cerebral venous sinus thrombosis (CVST), but also deep vein thrombosis and pulmonary thromboembolism.
Shimabukuro reported 15 TTS cases amid a backdrop of nearly 8 million vaccinations, as of April 21. All of the reported cases were among women aged 18-59, with a median age of 37. Of the 15 total, 12 were identified as CVST with thrombocytopenia; other cases occurred in locations like the portal vein and pulmonary artery. Other potential cases under review include males. Officials excluded one female with a “complex and unique” case history.
At least two patients experienced headaches starting more than six days post-vaccination, and other symptoms including chills and fever, while the later clinical course involved severe headaches and speech difficulty, among other symptoms.
Ten patients were identified as “severely thrombocytopenic,” with platelet levels fewer than 50,000 per cubic milliliter. (Normal platelet levels are 150,000-450,000 per cubic milliliter).
Shimabukuro said that of the total, six patients were treated with heparin, three patients died, seven remain hospitalized including four in intensive care, and five were discharged home.
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