United States federal health agencies have on Tuesday recommended the suspension of the use of Johnson & Johnson COVID-19 vaccine “out of an abundance of caution“.
The development comes after six recipients of the vaccine — all women– developed a “severe type of blood clot”.
Food and Drug Administration (FDA) and 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.
Read Also: Norway, Denmark, Iceland Suspend Use Of AstraZeneca COVID-19 Vaccine Over Blood Clot Fears
The agencies, in a joint statement, expressed that 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”.
They added;
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.
Treatment of this specific type of blood clot is different from the treatment that might typically be administered.
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.
As of 4/12, 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
— U.S. FDA (@US_FDA) April 13, 2021
World Health Organisation (WHO) in March 12 listed 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 and about seven million people in the country have received the vaccine.
All six cases occurred in women ages 18 to 48, with symptoms developing six to 13 days after they received the shot.
Doctors typically treat that type of blood clot with heparin, but health regulators noted that could be dangerous in this case and recommended a different treatment.
Meanwhile, J&J in a statement said “no clear causal relationship” has been identified between the blood clots and the vaccine, adding it is working closely with regulators to assess the data.
Similar reports of blood clot development in recipients of Oxford/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.
CDC will convene a meeting of Advisory Committee on Immunization Practices on Wednesday to further review the cases, federal health regulators said on Tuesday, while FDA is also investigating the cases.
It’s unclear how the pause will impact J&J’s goal to deliver 100 million doses to the U.S. by the end of May. The company has already been plagued by manufacturing issues after a plant run by Emergent BioSolutions ruined 15 million doses of the vaccine.
