The European Medicines Agency (EMA) said Tuesday (20/04) that it found after analysis a possible link between Johnson & Johnson vaccine against covid-19 and extremely rare blood clots, but reiterated that the benefits of the immune system outweigh the risks.
According to the EMA, its safety committee concluded that the warning of unusual blood clots with low platelets should be added as a “very rare side effect” on the label of the vaccine produced – by Janssen, the pharmaceutical arm of Johnson & Johnson. The agency recommended the same for the Oxford / AstraZeneca vaccine.
The agency pointed out that all cases of thrombosis occurred in adults under the age of sixty, most of them women, during a period of up to three weeks after vaccination. The agency said it used all available evidence in its analysis, including eight serious cases reported in the United States of blood clots linked to low platelets, including death.
The European regulatory authority also said that most strokes occurred in the brain and abdomen, as well as in cases that occurred after application of the Oxford / AstraZeneca immunity, which also concluded that it had more benefits than risks.
Because COVID-19 is “linked to the risk of hospitalization and death,” the CDC insists that “the overall benefits of the Janssen vaccine in preventing disease outweigh the risks of side effects.”
“A plausible explanation for the combination of thromboembolism and low platelet count is the immune response, resulting in a condition similar to that sometimes seen in patients treated with heparin. A low platelet count is usually associated with bleeding, not clots,” the European Medicines Agency said.
Strokes are rare in the United States and delayed in Europe
A week ago, US health regulatory agencies recommended suspending use of Johnson’s immunity after six cases of stroke were reported after about 7 million doses were applied in the country. All cases occurred in women under the age of 50.
On the recommendation of US agencies, Johnson & Johnson has decided to delay the launch of its immunization device in the European Union (EU). The pharmaceutical company has advised European governments to stock up on their doses until the EMA issues guidance on using the vaccine. Johnson’s goal is to supply the block with 55 million doses by the end of June, as agreed.
The Johnson vaccine is one of four vaccines against Covid-19 that have been authorized for use in the European Union, along with vaccines from Pfizer / Biontec, Moderna and Oxford / AstraZeneca.
The postponement of the start of mass vaccination with Johnson’s immunity was another blow to vaccination efforts in the block, which was already plagued by shortages of doses, logistical problems and concerns about unusual strokes that occurred in people who had received AstraZeneca’s immunity.
More information in a moment …