FDA restricts Johnson & Johnson COVID-19 vaccine use due to blood clot risk
- The FDA on Thursday restricted the emergency use authorisation of Johnson & Johnson COVID-19 vaccines
- It cited risks of potentiall fatal blood clots
- As many as 18.7 million J&J vaccines have been administered in the US thus far
The US Food and Drug Administration (FDA) on Thursday announced that it would considerably limit the emergency use authorization of the Johnson & Johnson/Janssen COVID-19 vaccine in view of a health risk that was recently discovered.
"Today, the U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine," the FDA announced in a statement on Thursday.
The decision to limit the emergency use authorization was taken after the FDA found the J&J COVID-19 vaccine to be associated with risk of thrombosis with thrombocytopenia syndrome (TTS), a rare condition that gives rise to a "syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets."
The FDA found that in select cases, symptoms of the aforementioned conditioned arose in patients one to two weeks after they had taken the J&J COVID-19 vaccine.
However, the federal agency clarified that the risk was small, saying, the "potential benefits of the vaccine for the prevention of COVID-19 outweigh the known and potential risks for individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and for individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine."
The FDA confirmed to CNN that the new restrictions not only apply to the initial doses, but to booster doses as well.
As of Thursday, 18.7 million J&J COVID-19 vaccines had been administered in the US as per the Centers for Disease Control and Prevention (CDC), with J&J vaccines accounting for 7.7% of the US' vaccinated population.