Johnson & Johnson to Resume COVID-19 Vaccine Distribution in Europe with Label Warning

Johnson & johnson said on Tuesday that will resume deployment of its COVID-19 vaccine in Europe after the region’s medical regulatory body said the benefits of the injection outweighed the risk of very rare and potentially fatal thrombi.

The European health regulator, the European Medicines Agency (EMA), on Tuesday recommended adding a warning about low platelet count thrombi to the vaccine label and said the benefits of the single-dose formula outweigh its risks.

J&J shares rose more than 2% on the US stock market after the news. Almost 8 million people in the United States have received this vaccine.

Use of the J&J serum was temporarily suspended by U.S. regulators last week after rare cases of brain thrombi associated with low platelet counts were reported in six women, leading the company to delay its launch in Europe.

J&J said that A new packaging label will include a warning about the risk of the rare side effect and instructions on how to recognize and treat it. The company said it will resume shipments to the European Union, Norway and Iceland, and is working on resuming clinical trials.

“It is an extremely rare event. We hope that by raising awareness and implementing clear diagnostic and therapeutic guidelines, we can restore confidence in our vaccine.J&J chief scientist Paul Stoffels said on a conference call to discuss the company’s results.

The Netherlands have announced that they will use the vaccine from Wednesday.

The Centers for Disease Control and Prevention and the United States Food and Drug Administration are also looking at very rare blood clots in people who have received the vaccine. An advisory committee will meet on Friday and can make a recommendation.

“The outcome of the vaccine review is important to global immunization efforts because the J&J vaccine does not have the extreme cold storage requirements of mRNA vaccines,” said Ashtyn Evans, analyst at Edward Jones, making reference to Moderna Inc vaccines and Pfizer Inc vaccines with its partner BioNTech SE.

J&J vaccine can be stored at normal refrigerator temperatures and should be used worldwide.

Similar rare thrombosis problems have been reported with the use of AstraZeneca’s COVID-19 vaccine.

MANUFACTURING PROBLEMS

J&J shipments were already delayed due to manufacturing issues at a Baltimore-based vaccine plant owned by Emergent BioSolutions Inc, which has yet to receive regulatory approval.

The FDA recently investigated a manufacturing error that resulted in the rejection of millions of doses last month. J&J said Tuesday it expects a response from FDA inspectors shortly. “We fix what we need to fix. We believe this will contribute to a positive result, ”said Joseph Wolk, CFO of J&J, on the conference call. He said J&J “should find out more in the next few days.”

J&J said that would meet its commitments to ship 200 million doses to Europe and 100 million to the United States.

The company also said it recorded $ 100 million in sales of the COVID-19 vaccine. J&J said the vaccine will be available on a non-profit basis until the pandemic is over.

(With information from Reuters / Manas Mishra and Carl O’Donnell)

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