The Centers for Disease Control and Prevention, alongside the Food and Drug Administration, have announced on Tuesday that they are now recommending a pause in the distribution and administration of the Johnson & Johnson COVID vaccine out of an “abundance of caution.”
According to a couple of released statements, officials are apparently examining whether or not the vaccine is linked to six different cases in the United States of a “rare and severe type of blood clot.”
Currently, the Johnson & Johnson vaccine has been given more than 6.8 million times across the United States.
“Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson #COVID19 vaccine. We are recommending a pause in the use of this vaccine out of an abundance of caution,” said a Twitter thread started by the FDA.
Each of the six cases occurred in a person between six and 13 days after they had received the vaccine. The cases will be reviewed by the CDC on Wednesday; the FDA will review the analysis and investigate the cases, too.
Johnson & Johnson said in a statement: “We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine.”
According to The New York Times, all six of those with the adverse reaction were females between the ages of 18 and 48. “One woman died and a second woman in Nebraska has been hospitalized in critical condition,” the report said.
“While the move was framed as a recommendation to health practitioners in the states, the federal government is expected to pause administration of the vaccine at all federally run vaccination sites,” the Times said in their report. “Federal officials expect that state health officials will take that as a strong signal to do the same. Within two hours of the announcement, Gov. Mike DeWine of Ohio, a Republican, advised all health providers in his state to temporarily stop giving Johnson & Johnson shots.”
“As of [April 12], 6.8m+ doses of the J&J vaccine have been administered in the U.S. CDC & FDA are reviewing data involving 6 reported U.S. cases of a rare & severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare,” the FDA Twitter thread went on to read.
“Treatment of this specific type of blood clot is different from the treatment that might typically be administered,” the FDA explained. “CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases.”
“Until that process is complete, we are recommending this pause,” the FDA announced. “This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.”
The agency closed out their Twitter thread by saying, “#COVID19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.”
#COVID19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.
— U.S. FDA (@US_FDA) April 13, 2021