WASHINGTON DC, USA: The US, South Africa and European Union have stopped 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.
Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said in a statement that as of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the US CDC and FDA are reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine.
The statement further read that in these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).
All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered.
Today’s developments with the J&J vaccine in the US are under close monitoring by @EMA_News and its pharmacovigilance bodies, with an open line to the @US_FDA and other international regulators. EU rollout has been paused by the company.
Vaccine safety is always paramount.
— Stella Kyriakides (@SKyriakidesEU) April 13, 2021
Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.
CDC will convene a meeting of the Advisory Committee on Immunisation Practices (ACIP) on Wednesday to further review these cases and assess their potential significance.
He said the FDA would review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.
Right now, these adverse events appear to be extremely rare. Covid-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following the Covid-19 vaccination very seriously. People who have received the J&J vaccine who develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.
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 thereafter 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.
The World Health Organization said 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 there are concerns this latest delay could throw it into further turmoil.
The Johnson & Johnson vaccine is yet to be approved in the UK, although 30 million doses are on pre-order. The Department of Health said the rollout delay would not affect vaccine supplies in the UK, or derail the aim to offer a jab to all adults by the end of July.
Canada has pre-ordered 10 million doses of the vaccine and is “still on track” to receive the first shipment by the end of the month, said Prime Minister Justin Trudeau.
“But obviously, we’re following closely the developments in the United States,” he added.