EU says J&J to miss vaccine supply target in second quarter

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BRUSSELS — Johnson & Johnson is predicted to overlook its COVID-19 vaccine provide goal to the European Union for the second quarter after tens of millions of doses had been banned to be used in Europe over security issues, an EU Fee spokesman stated.

The setback may trigger new delays to the bloc’s vaccination drive, though the EU is relying totally on the Pfizer-BioNTech shot to inoculate its inhabitants. Greater than half of adults within the EU have obtained at the very least one shot.

The European Medicines Company (EMA) final week stated J&J doses despatched to Europe from an Emergent manufacturing unit in the US wouldn’t be used as a precaution after a case of contamination with substances used for AstraZeneca photographs, that are additionally manufactured in that manufacturing unit.

EMA stated in an announcement to Reuters that 17 million doses had been banned from use within the bloc after that call.

“Following the non-release of those batches, the corporate just isn’t anticipated to be able to ship 55 million doses by the top of this quarter,” Stefan De Keersmaecker, the EU fee spokesman on well being, stated on Wednesday.

The EU has ordered a complete of 200 million doses from J&J, of which 55 million had been to be delivered by the top of June. The corporate has thus far delivered round 12 million photographs of its single-dose vaccine, of which solely about half have been administered, EU figures present.

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The spokesman declined to say what number of doses J&J was now anticipated to ship by the top of June.

“The member states and the Fee have voiced their sturdy issues relating to this shortfall,” he informed a information convention, including that the EU continued to work with the corporate “in direction of the supply of the agreed doses total on this and following quarters.”

Regardless of the potential delays that this may occasionally trigger, the spokesman stated the EU remained on monitor to fulfill its goal of immunizing 70% of its grownup inhabitants this summer season.

“Johnson & Johnson stays dedicated to supplying 200 million doses of its COVID-19 vaccine to the European Union, Norway and Iceland and can proceed to replace the European Fee and member states in a well timed method as we refine supply timelines,” J&J stated in an announcement.

DISCARDED DOSES?

EU regulators have prevented the use in Europe of the 17 million doubtlessly contaminated J&J doses however this doesn’t essentially imply their export is forbidden.

After having vaccinated giant components of their populations, rich nations are pledging to spice up inoculations in poorer states, the place new contagious variants may develop extra simply if the virus is allowed to flow into freely.

“EMA didn’t instruct Johnson & Johnson that these doses have to be destroyed, or given any instruction on what the corporate ought to do with them. They merely can’t be used within the European Union,” the Belgian drug regulator stated.

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Belgium’s medicines company is supervising the discharge in Europe of J&J COVID-19 vaccines. “When they are going to be delivered to different international locations, they’ve to hold the context and rationalization” of the manufacturing issues that they had confronted, an official on the Belgian regulator informed Reuters.

“EMA can not touch upon what the producer will do with unreleased batches to the EU,” EMA stated.

J&J stated that “out of an abundance of warning, the corporate won’t launch particular batches of its COVID-19 vaccine produced with drug substance manufactured by Emergent BioSolutions.”

Nevertheless, the corporate declined to touch upon whether or not this choice may even cowl the doses blocked within the EU. The U.S regulator has forbidden the use in the US of tens of tens of millions of J&J doses due to the identical security issues.

At a worldwide well being summit in Might, J&J stated it might ship 200 million doses to COVAX, this system co-led by the World Well being Group (WHO) to distribute vaccines globally, which has so for delivered solely about 90 million vaccines of the two billion deliberate this yr. (Reporting by Francesco Guarascio; modifying by Barbara Lewis)