J&J Rises on EU Nod To Resume Vaccine Rollout

© Reuters.

By Dhirendra Tripathi

Investing.com – Shares of Johnson & Johnson (NYSE:) erased their early losses and were up just short of 3% on securing the European regulator’s nod to resume supplies of its Covid-19 shots.

The company was able to convince the European Medicines Agency that the risk-reward ratio favored the application of the jabs, outscoring safety concerns.

The EMA’s Pharmacovigilance Risk Assessment Committee reviewed a small number of cases of very rare blood clots in combination with low platelet counts that can occur within one to three weeks following the injection.

The company has promised to carry, with the injection, a summary of product characteristics and leaflet to include important information on the diagnosis and management of this very rare adverse event.  

It said it remains committed to supplying 200 million doses of its vaccine to the E.U., Norway and Iceland.

The U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration currently are reviewing the same cases of blood clots.

The company earlier today raised its guidance for both sales and earnings per share after reporting healthy growth in its medical devices and pharmaceutical businesses.

J&J also saw the first $100 million in revenue from its Covid-19 shots.

The company increased its 2021 full-year guidance for adjusted operational sales growth to as much as 9.9% from 9.5% in January, and adjusted operational EPS growth to 16.8% from 16.4% earlier this year.






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