Federal health agencies in America have called for the rollout of the Johnson & Johnson (J&J) vaccine to be paused immediately due to some recipients developing rare blood clotting disorders within two weeks of being vaccinated. So far, nearly seven million people in the US have received shots of the J&J vaccine, which is not currently used in the UK. Six US recipients of the vaccine have developed disorders involving blood clots, all of them women aged 18-48. The New York Times has the story.
Federal health agencies on Tuesday called for an immediate pause in use of J&J’s single-dose coronavirus vaccine after six recipients in the US developed a rare disorder involving blood clots within about two weeks of vaccination.
All six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalised in critical condition. …
“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr Peter Marks, Director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, and Dr Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement. “Right now, these adverse events appear to be extremely rare.”
While the move was framed as a recommendation to health practitioners in the states, the Federal Government is expected to pause administration of the vaccine at all federally-run vaccination sites. Federal officials expect that state health officials will take that as a strong signal to do the same.
Scientists with the FDA and CDC will jointly examine possible links between the vaccine and the disorder and determine whether the FDA should continue to authorise use of the vaccine for all adults or limit the authorisation. An emergency meeting of the CDC’s outside advisory committee has been scheduled for Wednesday.
While the majority of the US’s vaccine supply comes from other sources, it is expected that this pause could “substantially complicate” the nation’s vaccination efforts. The move comes after Europe’s medicines regulator announced last week that it was reviewing possible links between the vaccine and rare blood clots. The jab is expected to be approved for use in the UK “within days“, with 30 million doses having already been ordered by the Government.
J&J said the following in a news release:
We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid vaccines. At present, no clear causal relationship has been established between these rare events and the J&J Covid vaccine.
The New York Times’s article is worth reading in full.
Stop Press: The European rollout of the vaccine has now been paused, according to a statement released by Johnson & Johnson. The company said: “We have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe.”