FDA Authorizes 10M JNJ COVID-19 Vaccine Doses, Asks To Discard 60M From Emergent Plant: NYT

  • The FDA has asked Johnson & Johnson JNJ to discard 60 million doses of its COVID-19 vaccine manufactured at the troubled Emergent BioSolutions Inc’s EBS Baltimore plant, the New York Times reported, citing people familiar with the matter.
  • A further 10 million JNJ doses would be allowed to be distributed with a warning that there was no guarantee that Emergent BioSolutions had followed proper practices.
  • The FDA said it had agreed that two batches of the vaccine were authorized for use but that multiple other batches were not suitable for use and others were being evaluated.
  • The agency added that it was not ready to authorize Emergent plant to manufacture the J&J vaccine.
  • In May, it was reported that FDA and Johnson & Johnson were expected to resume production at the Baltimore plant that could free up already manufactured doses of the vaccine that have been in quarantine and allow for the production of new doses.
  • Additionally, the FDA has extended the expiration date for the refrigerated J&J doses after reviewing information and determining that the vaccine can be stored at 2-8 degrees Celsius for 4.5 months instead of 3 months.
  • Price Action: JNJ shares are down 1.38% at $164.78 during the market trading session on the last check Friday.
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Posted In: BiotechGovernmentNewsHealth CareFDAGeneralBriefsCOVID-19 Vaccine
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