May 13, 2021

Janssen resumes shipping its vaccine to Europe after EMA endorsement

Johnson & Johnson (J&J) announced on Tuesday that it will resume the shipment of anticovid vaccines from its parent company Janssen to Europe, including information on their contraindications, after the endorsement of the European Medicines Agency (EMA).

Janssen delays the distribution of its vaccine in the EU after six cases of thrombi are detected in the US

Janssen delays the distribution of its vaccine in the EU after six cases of thrombi are detected in the US

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In a statement, the New Brunswick (New Jersey) -based firm echoes the recommendations issued today by the EMA’s safety committee (PRAC) after investigating eight cases of very rare thromboembolism detected in patients vaccinated with Janssen in the United States. .

J&J “remains committed to the provision of 200 million doses” of its coronavirus vaccine for the European Union, Norway and Iceland, it added.

“Following the recommendation of the PRAC, the company will resume shipping the COVID-19 vaccine from Janssen to the European Union, Norway and Iceland. Updated information from the EMA and health professionals will be available to national health authorities,” he explains. .

The EMA announced on Tuesday that it had found a “possible link” between the Janssen vaccine and rare blood clots but endorsed its use. This was communicated this Tuesday, in an opinion similar to the one pronounced with AstraZeneca.

The benefits therefore outweigh the risks in the opinion of the EMA: “A warning about unusual blood clots with low blood platelets should be added to the information on the Janssen vaccine, which should be included as very rare side effects of the vaccine”.

To reach this conclusion, the EMA has relied on all available data, including the eight cases – one of them in trials – from the USA of severe unusual thrombi associated with low platelet levels, one of them resulting in death. As of April 13, more than 7 million people had received the vaccine in the US.

On April 13, After the precautionary suspension of immunizations recommended by the US due to these cases of clots, J&J had decided to delay the delivery of its vaccine to Europe. On April 14, a day later, the first 146,000 doses of Janssen arrived in Spain, although the pharmaceutical company decided to keep them in its warehouses pending the EMA’s decision.


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