There has been a recommendation from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) on Tuesday morning to pause the Johnson & Johnson COVID-19 vaccine.
As of now, there is an investigation on whether the vaccine is linked to six cases in the U.S. alone “of a rare & severe type of blood clot.” Over more than 6.8 million people have been administered the Johnson & Johnson vaccine.
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,” a New York Times report stated.
“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,” started a Twitter thread from the FDA.
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.”
“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 reported. “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.”
Until that process is complete, we are recommending this pause. 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.
— U.S. FDA (@US_FDA) April 13, 2021
“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 continued.
“Treatment of this specific type of blood clot is different from the treatment that might typically be administered,” the FDA said. “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.”
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.
— U.S. FDA (@US_FDA) April 13, 2021
The agency closed the thread, “#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.”