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: J&J resumes European COVID-19 vaccine rollout with regulator-mandated safety warning

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Johnson & Johnson said on Tuesday it would restart its COVID-19 Janssen vaccine shipments to Europe, after the European Medicines Agency demanded that a “warning about unusual blood clots with low blood platelets” be included in the pharmaceutical’s product information for the shots.

  • The EMA said the events reported from the U.S. were “very rare side effects of the vaccine” and insisted that its “overall benefits (…) outweigh the risks of side effects.”
  • Use of the J&J vaccine in the U.S., where eight million people have so far received the shot, was temporarily halted last week after incidents were reported in six women. The number of cases has since risen to nine.
  • The company has entered an agreement to deliver 200 million doses to Europe. According to a report last week in Italian newspaper La Stampa, the European Union has decided not to renew its contracts with Johnson & Johnson, or AstraZeneca, another vaccine developer, at the end of the year. 
  • Italy started delivering batches of the Janssen vaccine to its regions as soon as Wednesday morning, as the Netherlands also resumed its rollout.

Read: Young, healthy adults will be deliberately reinfected with COVID-19 to boost vaccine development

The outlook: The EU, for now, is more focused on accelerating its struggling vaccination campaigns, which are only beginning to catch up after three months of bureaucratic and logistical delays. Only 7% of the European population has been fully vaccinated, compared with 26% in the U.S. and 15% in the U.K.

Read: Treating COVID-19 at home could soon be a reality in the U.K. as government steps up efforts

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