Week's news analysis

Benefits Johnson&Johnson vaccine
outweigh the risks', EMA says

by the editor with Reuters - 21 April 2021

The European Medicines Agency (EMA) said on Tuesday (April 20) the benefits of inoculating the Johnson & Johnson's COVID-19 vaccine outweighed the risk of developing blood clots, after it found a link between the vaccine and rare occurrences of the side effect. "We now have a detailed information in the labelling that alerts to these risks. We have detailed information for the healthcare professionals," the European agency's head, Emer Cooke, told a news conference in Amsterdam, adding the vaccine could help prevent hospitalisation and death.

The comment came after the agency's announcement of a review of blood clots cases prompted a pause in the rollout of the vaccine in Europe and the United States last week, the latest blow to efforts to tackle the pandemic, which has killed more than 3.1 million and infected 142.1 million worldwide.

The EMA examined eight cases of clotting that occurred in U.S. adults under 60 years, mostly women, within three weeks of vaccination with J&J's single shot.

"One of these events was already reported in the clinical trial (of the Johnson & Johnson COVID-19 vaccine) while seven occurred after the rollout of the vaccine in the United States," Sabine Straus, chair of EMA's safety committee, told the briefing. With both the AstraZeneca and J&J vaccines, the reports involve extremely rare clotting, mainly a type of blood clot called cerebral venous sinus thrombosis (CVST), which was seen in combination with low levels of blood platelets, called thrombocytopenia.

Straus said there were a number of symptoms that could help identify the side effect.
"Shortness of breath, chest pain, swelling in the leg, persistent abdominal pain, neurological symptoms and that includes severe headaches or persistent headaches, blurred vision and skin bruising beyond the site of the injection. Those are the most telling symptoms that we have been able to identify based of the careful review of the cases," Straus said.

U.S. authorities will meet on Friday to discuss whether to resume using the vaccine.

J&J, which recorded $100 million in COVID-19 vaccine sales, has delayed rolling out the vaccine to Europe, but said on Tuesday it was prepared to resume the deployment. It has said it would aim to deliver 55 million doses to the EU, as contracted, by the end of June.

J&J's vaccine, developed by its Janssen unit, is one of four COVID-19 vaccines authorised for use in Europe.

Denmark's health authority said on Wednesday it expects to announce its decision on how to proceed with Johnson & Johnson's COVID-19 vaccine next week pending further investigations into its possible link to rare blood clots.

Italy's health ministry on Tuesday recommended that the Johnson & Johnson COVID-19 vaccine be used for people over the age of 60, after Europe's drugs regulator said the jab may be linked to blood clotting issues among younger people. The ministry has already made the same recommendation for the use of the AstraZeneca vaccine in Italy.

RELATED What is thrombocytopenia, the rare blood condition possibly linked to the AstraZeneca vaccine?

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