US federal health agencies on Tuesday recommended pausing the use of Johnson & Johnson's single-dose Covid-19 vaccine after six recipients developed a rare disorder involving blood clots.
The US Centres for Disease Control and Prevention (CDC) will hold an advisory meeting on Wednesday to review the cases.
All the six recipients were women between the ages of 18 and 48. One woman died and a second in Nebraska has been hospitalised in critical condition, the New York Times reported, citing officials.
The CDC and the Food and Drug Administration said in a joint statement that the adverse events appear to be extremely rare right now.
Still, authorities are recommending that people who were given the J&J vaccine who are experiencing severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after receiving the shot contact their health care provider.
Officials say they also want to educate vaccine providers and health professionals about the “unique treatment” required for this type of clot.
Also on Tuesday, Johnson & Johnson says it is delaying the rollout of its coronavirus vaccine in Europe amid the US probe into rare blood clots.
“We have been reviewing these cases with European health authorities,” the company said. “We have made the decision to proactively delay the rollout of our vaccine in Europe.”
Hundreds of thousands of doses of the vaccine were due to be shipped to Europe in the coming weeks.
As of April 12, more than 6.8 million doses of the J&J vaccine have been administered in the United States.
The vaccine received emergency use authorisation from the FDA in late February with great fanfare, with hopes that its single-dose and relatively simple storage requirements would speed vaccinations across the country. Yet the shot only makes up a small fraction of the doses administered in the US as J&J has been plagued by production delays and manufacturing errors at the Baltimore plant of a contractor.
Last week, the drugmaker took over the facility to scale up production in hopes of meeting its commitment to the US government of providing about 100 million doses by the end of May.
Until now concern about the unusual blood clots has centred on the vaccine from AstraZeneca, which has not yet received authorisation in the US.
Last week, European regulators said they found a possible link between the shots and a very rare type of blood clot that occurs together with low blood platelets, one that seems to occur more in younger people.
The European Medicines Agency stressed that the benefits of receiving the vaccine outweigh the risks for most people. But several countries have imposed limits on who can receive the vaccine; Britain recommended that people under 30 be offered alternatives.
The J&J and AstraZeneca vaccines are made with the same technology. Leading Covid-19 vaccines train the body to recognise the spike protein that coats the outer surface of the coronavirus. But the J&J and AstraZeneca vaccines use a cold virus, called an adenovirus, to carry the spike gene into the body. J&J uses a human adenovirus to create its vaccine while AstraZeneca uses a chimpanzee version.
The company's shares were down 3 percent before the opening bell. (AP & Reuters)
Last updated: 2021-04-13 HKT 22:20
US recommends 'pause' in J&J vaccine over clot fears
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