US FDA requests further information before making decision on current pause of the Johnson & Johnson Covid-19 vaccine roll-out

The US FDA’s Advisory Committee on Immunization Practices has declined to make a recommendation on the current pause of the vaccine in the US, indicating they needed more information about the rare blood clots observed in a handful of patients.

SPS commentary:

The Committee met to discuss the pause in the use of the J&J vaccine in the U.S, following reports of extremely rare, but potentially life-threatening cerebral venous sinus thrombosis (CVST), observed in six cases out of almost 7 million doses.

The European Medicines Agency is reviewing this issue and expects to issue a recommendation next week. While its review is ongoing, it remains of the view that the benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects.

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