Federal health agencies in the United States called for an immediate halt on the distribution of the Johnson & Johnson single-dose COVID-19 vaccine after it emerged that six recipients in the country developed a rare disorder leading to blood clots, a report from The New York Times explains.
The FDA announced, alongside the CDC, that both agencies "are recommending a pause in the use of this vaccine out of an abundance of caution."
The agencies wish to pause the administration of the vaccine to give regulators time to investigate any potential link between the rare blood clots and the vaccine.
All six of the recipients who developed the rare disorder were women aged between 18 and 48. One woman died and a second is in critical condition, the officials explained.
In a series of tweets, the FDA announced that the "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."
The agencies are recommending a pause on the vaccination until that review process is completed.
"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," the FDA explained.
The FDA's tweets were published at 7 AM local time (11 AM GMT), and a news conference is scheduled for 10 AM (14 AM GMT).
Blood clot link investigations ongoing amid mass vaccine rollout
Almost seven million people in the United States have received Johnson & Johnson vaccination thus far, with approximately nine million more doses having been shipped out for administration, according to the CDC.
The CDC's data also shows that close to 98 million have received at least one shot of the Pfizer vaccine and roughly 84 million have been administered the Moderna vaccine.
The news comes almost a week after the European Medicines Agency (EMA) announced that unusual blood clots with low blood platelets should be listed as a very rare side effect of the Oxford/Astrazeneca vaccine, following an investigation into potential links.
Though research into the Johnson & Johnson vaccine is ongoing and any potential links must be taken seriously, it is important to emphasize that one person dying from a blood clot following the administration of the vaccine does not necessarily mean both events are linked.
In March, for example, news outlets in Spain strongly linked the death of a teacher from a brain hemorrhage to her having recently been administered the vaccine. As per El País, The subsequent autopsy showed "conclusively" that there was "no causal relationship" between the administration of the vaccine and the death.
The EMA, the CDC, and the FDA are all continuously monitoring the safety of the vaccines as they continue to be rolled out to millions worldwide.
This was a developing story and was updated as new information emerged.