Johnson & Johnson vaccine paused over rare blood clots

(BBC) – The US, South Africa and European Union will temporarily stop the rollout of the Johnson & Johnson (J&J) Covid jab, after reports of rare blood clotting.

Six cases were detected in more than 6.8 million doses of the vaccine, the US Food and Drug Administration (FDA) said.

Johnson & Johnson has paused its EU rollout, which started this week.

It follows similar cases after doses of the AstraZeneca vaccine, which prompted curbs to its use.

The FDA said it was recommending the temporary pause “out of an abundance of caution”. It confirmed that one patient died from blood clotting complications, and another is in a critical condition.

All six cases were in women aged between 18 and 48, with symptoms appearing six to 13 days after vaccination.

Following the advice, all federal sites in the US have stopped using the vaccine until further investigations into its safety are completed. State and private contractors are expected to follow suit.

The US has by far the most confirmed cases of Covid-19 – more than 31 million – with more than 562,000 deaths, another world high.

Johnson & Johnson is a US health care company, but the vaccine was developed mainly by its pharmaceutical branch in Belgium, and is also known as Janssen. Unlike some of the other jabs, it is given as a single shot and can be stored at normal refrigerator temperatures, making it easier to distribute in hotter climates or more remote areas.

While many countries have pre-ordered millions of doses, it has only been approved in a few nations.

It was cleared for use in the US on 27 February, but the Pfizer-BioNTech and Moderna vaccines have been used more widely. The J&J vaccine has been administered to nearly seven million people in the US, which is around 3% of the total immunisations given so far.

Dr Anthony Fauci, the country’s top Covid adviser, said it was too early to comment on whether it could have its authorisation revoked.

South Africa, which was the first country to administer the vaccine, has also paused its use, although no cases of blood clots have been reported in the country.

The jab became the preferred vaccine there after studies showed it had a higher protection rate against the South African variant than other jabs. Since mid-February, nearly 300,000 healthcare workers have received it.

South African President Cyril Ramaphosa receives the Johnson and Johnson vaccination at the Khayelitsha Hospital near Cape Town, South Africa, February 17, 2021.image copyrightReuters

The World Health Organization told Reuters it was monitoring the situation and waiting for reports from the US and European regulators.

However deliveries of the vaccine to EU countries started just 24 hours before J&J said it would pause the European rollout. As it has not been administered in the EU yet, experts there will be looking to the United States to see what their next move is.

The EU’s vaccine roll-out has been criticised by the WHO for being too slow, and and there are concerns this latest delay could throw it into further turmoil.

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