One batch of Johnson & Johnson’s JNJ COVID-19 vaccines failed quality standards and are not fit for use, reported the New York Times on late Wednesday.
What Happened: The company had found a problem with an ingredient used in the vaccine produced at Emergent Biosolutions Inc’s EBS site in Baltimore.
Emergent BioSolutions is a manufacturing partner to both JNJ and AstraZeneca Plc AZN.
Workers at the plant accidentally conflated the ingredients several weeks ago, contaminating up to 15 million doses of JNJ’s vaccine.
Federal officials have attributed the mistake to human error.
Why It Matters: The mix-up has delayed future shipments of JNJ doses in the U.S. while the FDA is investigating the incident.
The error does not affect any Johnson & Johnson doses currently being delivered, including the shipments that states are counting on next week.
New shipments of the JNJ vaccine totaling 24 million doses in the next month were supposed to come from the Baltimore plant. Those deliveries are now in question while the quality control issues are sorted out.
Federal officials still expect to have enough doses from Johnson & Johnson and the two other approved coronavirus vaccine makers to meet President Biden’s commitment to providing enough vaccine to immunize every adult by the end of May.
Johnson & Johnson has strengthened its control over Emergent BioSolutions’ work to avoid additional quality lapses.
None of the doses ever left the plant, and the lot has been quarantined.
Earlier this month, EBS’ CEO Bob Kramer said that the company is operating at a level where its annual capacity is well over 1 billion COVID-19 vaccine doses.
Price Action: EBS shares are down 8.5% at $85.05, and JNJ stock is down 0.8% at $163.25 in the premarket session on the last check Thursday.
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