EU regulator supports use of Johnson & Johnson COVID-19 vaccine despite discovery of possible link to blood clots
The European medicines regulator has discovered a possible link between Johnson & Johnson’s COVID-19 vaccine and rare blood clotting problems in adults who have received doses in the United States, but has supported its overall benefits against any risk.
The European Medicines Agency (EMA) said on Tuesday its safety committee concluded that a warning about unusual blood clots with low platelets should be added to the vaccine’s labels, just as it also demanded from the manufacturer of rival vaccines AstraZeneca-Oxford.
The results are a blow to the European Union, which is battling major obstacles to its vaccination campaign after several countries suspended or limited the use of AstraZeneca’s vaccine on possible blood clots.
The EMA found that all cases of coagulation occurred in adults under the age of 60, mostly women, within three weeks of being vaccinated with a single shot of Johnson & Johnson.
He said all available evidence, including eight US case reports, had been part of his assessment.
The watchdog also said most of the clots occurred in the brain and abdomen, as was the case with the AstraZeneca injection, which is also being studied for similar blood clotting issues.
“A plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to that sometimes seen in patients treated with heparin,” said the EMA.
The United States had recommended Johnson & Johnson to take a break
The U.S. health regulator last week recommended suspending use of the single-dose Johnson & Johnson vaccine after six women under 50 developed rare blood clots after receiving it, in a further setback to the global efforts to combat the pandemic.
The cases have been reported in more than seven million doses administered in the United States as of April 13, the EMA said.
Johnson & Johnson, which has recorded $ 100 million in sales of COVID-19 vaccines, has delayed the deployment of the vaccine in Europe, but is ready to resume deployment. He said he would aim to deliver 55 million doses to the EU, as planned, by the end of June.
Johnson & Johnson’s vaccine, developed by its Janssen unit, is one of four COVID-19 vaccines approved for use in Europe.
It is also one of four vaccines approved here in Canada, with a first shipment scheduled for later this month, alongside the AstraZeneca vaccine, which has been a source of controversy amid changing recommendations related to blood clot issues.
As CBC News reported on Monday, Canada’s National Advisory Committee on Immunization previously recommended that provinces suspend use of the vaccine in people under 55 due to safety concerns, but new documents show that ‘he will now recommend expanding the use of the AstraZeneca vaccine. to younger age groups under specific conditions.
Several provinces have already moved to a lower age threshold for the vaccine, for which Health Canada maintains its safe use.