J&J vaccine halted in US due to blood clots
pharmafile | April 14, 2021 | News story | Research and Development | CDC, COVID-19 vaccine, FDA, Janssen, Johnson & Johnson, pharma, pharma news
The CDC and FDA have recommended a pause in the use of the Johnson & Johnson COVID-19 vaccine in the US, over fears that the shot may cause blood clotting.
J&J have also made the decision to delay the rollout of their vaccine in Europe, and pause vaccinations in all Janssen COVID-19 clinical trials, due to the concerns.
These moves come after six reported cases of cerebral venous sinus thrombosis, a rare and severe type of blood clot that was seen in combination with low levels of blood platelets in people administered with the vaccine.
All six cases occurred among women between the ages of 18 and 48, with symptoms occurring 6 to 13 days after vaccination.
These six cases have arisen from more than 6.8 million vaccinations administered in the US, with White House Chief Medical Advisor Anthony Fauci pointing out on Tuesday that the chances of developing the side effect from the jab were, “less than one in a million”.
The CDC will meet later today to further review the cases of blood clotting and their significance, with the FDA then reviewing that analysis themselves. In a joint press release, the two authorities said: “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.”
Treatment of this specific type of blood clot is different from that which might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.
The US have ordered 200 million doses of the one-shot J&J vaccine in their bid to vaccinate every American adult by the end of May, although these latest developments may alter these plans.
The UK have also placed an order of 30 million doses, with the vaccine currently under review by the MHRA. The country recently chose not to recommend the Oxford-AstraZeneca vaccine to under-30s due to blood-clotting fears.
Jack Goddard
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