A manufacturing error at a plant in Baltimore ruined a batch of Johnson & Johnson's COVID-19 vaccine, the company said in a statement Wednesday.

What You Need To Know

  • A manufacturing error ruined a batch of Johnson & Johnson's COVID-19 vaccine, according to the company

  • The news was first reported by the New York Times, who also reported that workers at the plant, which produces both Johnson & Johnson and AstraZeneca vaccines, conflated the two ingredients, ruining the J&J doses 

  • Johnson & Johnson committed to provide more staff to supervise manufacturing of their vaccine at the plant

  • White House Coronavirus Response Coordinator Jeff Zients addressed the manufacturing efforts, noting that the error "did not impact any J&J doses that have been administered," as those were produced at a different FDA facility

The news was first reported by the New York Times. 

According to the Times, workers at the plant, which is run by Emergent BioSolutions and produces both Johnson & Johnson and AstraZeneca vaccines, conflated the two ingredients, ruining the J&J doses.

"This quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine," Johnson & Johnson said in a statement. "This batch was never advanced to the filling and finishing stages of our manufacturing process."

In a White House COVID-19 briefing Friday, White House Coronavirus Response Coordinator Jeff Zients addressed the manufacturing efforts, noting that the error "did not impact any J&J doses that have been administered," as those were produced at a different FDA facility.

Zients noted that Johnson & Johnson will be "at or near" 100 million doses by the end of May.

While Johnson & Johnson did not say how many doses were ruined, the Times reports the error destroyed 15 million doses. The Times also reported that federal officials attributed it to human error.

"The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration (FDA)," Johnson & Johnson said in a statement.

The company committed to continue working with the FDA and Emergent toward getting Emergency Use Authorization for the facility, as well as provide "additional experts in manufacturing, technical operations, and quality to be on-site at Emergent to supervise, direct, and support all manufacturing of the Johnson & Johnson COVID-19 vaccine."

The CDC said Wednesday that another 11 million doses of the Johnson & Johnson vaccine will be avilable for shipments starting Thursday – the error did not affect doses currently being shipped nationwide and used, as those were produced at a facility in the Netherlands.

Emergent, which has been producing bulk drug substance at one of its factories in Baltimore, declined to comment to The Associated Press.

J&J had pledged to provide 20 million doses of its vaccine to the U.S. government by the end of March, and 80 million more doses by the end of May. Its statement on the manufacturing problem said it was still planning to deliver 100 million doses by the end of June and was “aiming to deliver those doses by the end of May.”

President Joe Biden has pledged to have enough vaccines for all U.S. adults by the end of May. The U.S. government has ordered enough two-dose shots from Pfizer and Moderna to vaccinate 200 million people to be delivered by late May, plus the 100 million shots from J&J.

A federal official said Wednesday evening the administration’s goal can be met without additional J&J doses.

A J&J spokesman said earlier Wednesday that J&J met the end-of-March goal, but did not respond to questions about whether the Emergent plant had been cleared by FDA.

As of Wednesday, J&J had provided about 6.8 million doses, according to the U.S. Centers for Disease Control and Prevention’s online vaccine tracker. 

The FDA said it was aware of the situation but referred questions to Johnson & Johnson.

The Associated Press contributed to this report.