Europe’s medicines regulator has found a possible link between Johnson & Johnson’s coronavirus vaccine and very rare cases of unusual clotting disorders that prompted authorities in Europe and the US to pause the shot’s rollout last week.
The Amsterdam-based European Medicines Agency (EMA) said in a statement on Tuesday its safety committee had concluded a warning should be added to the vaccine’s product information, but that the shot’s benefits outweighed its risks.
The EMA said it had examined eight instances of serious cases of unusual blood clots associated with low levels of blood platelets, including one death, that had occurred in the US, where more than 7 million people have so far received the shot.
It said all the cases had occurred in people under 60 years of age, the majority in women, within three weeks after vaccination. As with the AstraZeneca vaccine, most clots had occurred in the brain and abdomen, it said. It concluded the events “should be listed as very rare side-effects” of the vaccine.
“Healthcare professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination,” the agency said.
“Covid-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of [the vaccine] in preventing Covid-19 outweigh the risks of 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 vaccine last week, a day after deliveries of the shot had got under way, advising governments to store their doses until the EMA had issued guidance on their 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 this Friday, although possibly with restrictions for some age groups.
Joseph Wolk, Johnson & Johnson’s chief financial officer, said before the EMA’s announcement the company was “very confident” in its vaccine and hoped US health agencies would reach a decision by the end of the week.
The EU and US agencies concerns echo those around the Oxford/AstraZeneca vaccine, which faced a similar setback last month when several European countries suspended its use temporarily over unusual blood clots in a small number of recipients.
Most have resumed vaccinations with the AstraZeneca shot after the EMA said that while there may be a possible link between Astra Zeneca’s jab and the rare clotting events, the vaccine’s benefits still far outweighed the risks.
However, a dozen European countries, including France, Germany, Italy and Spain, are limiting use of the Anglo-Swedish shot to people over 55, 60 or 65, while Denmark has stopped administering it altogether and Norway has yet to formally make a decision.
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 might 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.
The EU, whose vaccination programme suffered from early supply shortages and logistical problems but is picking up speed steadily across many of its 27 member states, 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.
“We are confident that we will be able to deliver enough doses, but it is true also that it is up to member states to organise themselves to be ready for that,” Breton said. He said 53 factories were 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 a further 50m Pfizer/BioNTech doses this quarter provided extra security, he said.
That deal, along with a converted option to buy an extra 100m Pfizer doses this year, has provided “room for manoeuvre” to help offset the AstraZeneca restriction and any limitations imposed on the Johnson & Johnson shot, Breton said.