Health organisations are reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine.
THE US Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) have recommended that the roll-out of the Johnson & Johnson (J&J) vaccine be paused “out of an abundance of caution”.
In a joint statement, Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, and Dr Anne Schuchat, principal deputy director of the CDC, said the organisations were reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine.
“In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered,” they said.
The CDC was expected to convene a meeting of the Advisory Committee on Immunisation Practices on Wednesday to review these cases further and assess their potential significance.
“FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health-care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”
These adverse events appear to be “extremely rare”, they said, adding: “Covid-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following Covid-19 vaccination very seriously.”
It’s unclear how this will impact South Africa’s vaccine roll-out.
Health Minister Zweli Mkhize had confirmed that South Africa secured 51 million doses of vaccines from J&J and Pfizer.
The country recently received a new batch of J&J vaccine before the expected roll-out of phase 2 of the vaccination drive.
The latest batch of vaccines due to touch down at OR Tambo International Airport had been delayed because of a flight “mix up“.