Johnson & Johnson Set To Resume COVID-19 Vaccine Rollout In Europe — With A Warning On The Label

Johnson & Johnson JNJ said Tuesday that the European rollout of its COVID-19 vaccine is set to continue after it got the go-ahead from the regulator on the continent.

What Happened: The multinational pharmaceutical giant said in a statement that the European Medical Agency’s Pharmacovigilance Risk Assessment Committee had given updated guidance for the use of its COVID-19 vaccine.

The EMA said that the “overall benefit-risk profile remains positive.” 

The guidance comes after the PRAC reviewed a “small number of cases of a very rare adverse event involving blood clots in combination with low platelet counts that can occur within approximately one to three weeks following injection with the Company's COVID-19 vaccine,” said Johnson & Johnson.

As a result of the guidance, Johnson & Johnson will update the vaccine’s Summary of Product Characteristics and Package Leaflet to include information on diagnosis and management of adverse effects.

Why It Matters: Johnson & Johnson said it will resume the shipment of the vaccine in the European Union, Norway and Iceland.

In the United States, authorities in multiple states halted the distribution of Johnson & Johnson’s vaccine due to concerns about adverse reactions earlier in the month.

Last week, the company’s stock fell — leading to buying by bulls — after the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration recommended that the use of Johnson & Johnson’s COVID-19 vaccine be paused in the country. 

See Also: US Puts Johnson & Johnson In Charge Of Troubled Vaccine Plant In Baltimore, Removes AstraZeneca

This month, the EMA concluded that there are possible links between the COVID-19 vaccine made by AstraZeneca Plc AZN and blood clots. The agency said these should be listed as a “very rare side effect.”

On Tuesday, Johnson & Johnson reported $100 million in COVID-19 vaccine sales and better than expected Q1 earnings of $2.59 per share, up 12.6% on a year-over-year basis. The earnings beat estimates of $2.34 per share.

Price Action: Johnson and Johnson shares closed 2.33% higher at $166.48 on Tuesday and fell 0.2% in the after-hours trading.

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