The United States federal health agencies on Tuesday recommended suspending the use of the Johnson & Johnson COVID-19 vaccine.
The development comes after six recipients of the vaccine — all women– developed a “severe type of blood clot”.
The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) said they will stop using the vaccine at federal sites and asked states to do so as well while they investigate safety issues.
The agencies, in a joint statement, said they 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”.
“Treatment of this specific type of blood clot is different from the treatment that might typically be administered,” they 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. 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 World Health Organisation (WHO) had on March 12 listed the Johnson & Johnson COVID-19 vaccine for emergency use in all countries.
It is the third COVID-19 vaccine that has received FDA’s authorisation, and also the first single-dose COVID-19 vaccine available in the US.
About seven million people in the US have received the vaccine.
Similar reports of blood clot development in recipients of the AstraZeneca vaccine made several European countries to suspend use of the product in March.
They have, however, resumed using the vaccine after European Union and British regulators said there was no link between the vaccine and the reported side effects.