- Emergent BioSolutions Inc EBS has manufactured over 115 million doses of drug substance used in the Johnson & Johnson JNJ COVID-19 vaccine, 60 million doses of which are in vials and ready to deploy at U.S. regulators’ discretion, reports Bloomberg.
- The contract manufacturer has been producing the J&J single-shot vaccine since late 2020, according to a source.
- The stockpile size, which is not yet cleared by the FDA for release, hasn’t been previously reported.
- A Biden administration official did confirm the numbers but declined to specify further.
- The supply was expected to be cleared for use last month. But staff conflated materials for the J&J vaccine with those for doses from AstraZeneca Plc AZN that led to discarding 15 million doses of an ingredient used in the J&J vaccine.
- The 115 million doses worth of ready-made drug substance do not include the 15 million discarded doses, said the person.
- Bloomberg also stated that the 60 million vialed doses containing the Emergent-made drug substance are not stored at the troubled Bayview facility.
- To date, a J&J-run facility based in the Netherlands is the only one in the global manufacturing network cleared to make the drug substance used in the vaccine.
- Last week, the FDA concluded the inspection of the Bayview facility released a couple of blistering observations on the cross-contamination, sanitary issues, and lack of staff training.
- The U.S. regulator said on April 21 that manufactured vaccines from the Bayview facility will undergo additional testing and evaluation.
- In its Q1 earnings call conference, the company said it hopes to respond to U.S. regulators within days on how to resolve the problems at its Baltimore plant and start vaccine production.
- Price Action: EBS shares are down 3.1% at $61.2 during the market session on the last check Friday.
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