Emergent BioSolutions Poised To Receive FDA Nod to Restart J&J COVID-19 Shot Production at Baltimore Plant After Mishap: WSJ

  • The FDA and Johnson & Johnson JNJ are expected to announce that contamination problems at Emergent BioSolutions Inc’s EBS Baltimore Bayview plant have been resolved, and production is set to resume, the Wall Street Journal reported.
  • The deal with the FDA could free up already manufactured doses of the vaccine that have been in quarantine and allow for the production of new doses.
  • The FDA had halted production of J&J’s vaccine at the plant in April after an inspection flagged severe quality control and sanitary issues.
  • As a part of the arrangement, 60 million doses of the J&J shots could be cleared for use.
  • An additional 60 million doses of the AstraZeneca Plc’s AZN shot could become available as well, according to the Wall Street Journal.
  • Robert Kramer, EBS’s CEO, had previously offered mixed messages on what exactly happened to lead to the mixup but clarified in front of a House subcommittee that some of the problems arose due to having to produce two COVID-19 vaccines at large scale, which the company said strained the capacity of its equipment.
  • Emergent chief executive Robert Kramer told a House committee last week that the company had produced enough of a key ingredient to yield more than 100 million doses of the J&J vaccine.
  • The company has been taking corrective measures and has been in talks with FDA and J&J over the steps needed to reopen the facility.
  • Price Action: EBS stock is up 4.3% at $60.32, and JNJ shares are up 1.14% at $170.7 during the market session on the last check Friday.
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Posted In: BiotechNewsHealth CareContractsFDAGeneralBriefsCOVID-19 VaccineWall Street Journal
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