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Possible link between J&J Covid vaccine and rare blood clots, EU regulator finds

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Jon Henley Europe correspondent
·4-min read
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<span>Photograph: Dado Ruvić/Reuters</span>
Photograph: Dado Ruvić/Reuters

Europe’s medicines regulator has found a possible link between Johnson & Johnson’s coronavirus vaccine and rare cases of unusual blood clotting disorders it said were “very similar” to those that had occurred with the AstraZeneca shot.

The European Medicines Agency (EMA) on Tuesday recommended a warning should be added to the vaccine’s product information, but stressed that the benefits of the shot – which was put on hold last week in Europe and the US – outweighed its risks.

The EMA said it had examined eight serious cases of unusual blood clots associated with low levels of blood platelets, including one death, in the US, where more than 7 million people have so far received the vaccine.

It said all the cases had occurred in people under 60, mostly women, within three weeks of vaccination. As with AstraZeneca, most occurred in the brain and abdomen. It said the events should be listed as “very rare side-effects” of the vaccine.

“This is a very rare effect, but it is very important for doctors and patients to be aware of the signs so that they can spot any concerns and seek specialists’ help as soon as possible,” Emer Cooke, the EMA’s executive director, said.

“Thousands of people are still dying every day of Covid-19 and these vaccines play an immensely important role in combating this pandemic,” she added. “The vaccine’s benefits in preventing Covid-19 outweigh the risks of these very rare side-effects.”

The announcement came as the European commissioner in charge of the bloc’s vaccine supplies said he was confident the EU’s 27 member states would have enough doses to fully vaccinate 70% of their adult populations by mid-July.

Johnson & Johnson halted the European rollout of its single-dose vaccine last week, a day after deliveries of the shot began, advising governments to store their doses until the EMA had issued guidance on their use.

Cooke said EU member states could now “take decisions on how to roll out this vaccine based on their national situation”. As with the AstraZeneca shot, some are expected to impose restrictions on the Johnson & Johnson vaccine’s use.

Reports this week suggested the US, where health agencies put the single-dose jab on hold on 13 April, could decide to lift its suspension of the vaccine as early as Friday, although possibly with restrictions for some age groups.

The concerns with the vaccine echo those around the Oxford/AstraZeneca shot, which faced a similar setback last month when several European countries suspended its use temporarily over unusual blood clots in a small proportion of recipients.

Most have resumed vaccinations with the AstraZeneca shot although a dozen, including France, Germany, Italy and Spain, are limiting its use to people over 55, 60 or 65, and Denmark has stopped administering it altogether.

Scientists in Germany and Norway have suggested some people are experiencing an abnormal immune system response to the vaccine, leading some experts to suspect a similar mechanism may be occurring with the Johnson & Johnson shot.

Both vaccines use the same technology, training the body’s immune system to recognise the spike protein that coats the coronavirus by using a cold virus – called an adenovirus – to carry the spike gene into the body.

Sabine Straus, the head of the EMA’s safety committee, said it was still too early to confirm a common mechanism. “The AstraZeneca vaccine is an adenovirus-based vaccine, as is the Johnson vaccine,” Straus said. “So there are quite some similarities between the two vaccines – but there are also differences. They use different vectors, for example, and also the spike protein is different. So I think it’s too early to draw conclusions.”

Besides the eight cases in Johnson & Johnson recipients, all in the US, the EMA said there had been 287 such incidents in people who had received the AstraZeneca vaccine, including 142 in Europe. The figures for the Pfizer/BioNTech and Moderna jabs were 25 and five.

Straus said that in relation to the number of people who had received the latter two vaccines, which use a different technology known as mRNA, the number of unusual clotting events observed was so far “lower than what we would expect in the general population”.

The EU, whose vaccination programme suffered from early supply shortages and logistical problems but is now picking up speed, has ordered 200m doses of the Johnson & Johnson vaccine.

Thierry Breton, the European commissioner who heads the bloc’s vaccine taskforce, said on Tuesday at least 12 member states were confident of being able to meet the commission’s target of vaccinating 70% of their adult population by mid-July.

Breton said 53 factories were now producing vaccines in the EU. “I am now certain of how many doses are in production, and how many millions will be delivered each week,” he said.

An announcement last week that the EU would receive an extra 50m Pfizer/BioNTech doses this quarter should help offset restrictions on the use of the AstraZeneca and Johnson & Johnson shots, Breton said.