Johnson & Johnson will oversee all aspects of vaccine production at the Emergent BioSolutions facility in Baltimore.
"Our COVID-19 vaccine candidate development program is created to deliver on our commitment to protect people of all ages from this pandemic", said Mathai Mammen, Global Head, Janssen Research & Development, Johnson & Johnson.
Regarding the J&J mix-up, "it wasn't the case where an ingredient from one vaccine contaminated or impacted the other", Emergent CEO Robert Kramer said in an interview with CNBC's Meg Tirrell.
An FDA investigator last April discovered improper training, record keeping, testing procedures and more at Emergent BioSolution's Baltimore Bayview facility, the Washington Post reports. With three federally authorized vaccines (the other two are by Pfizer-BioNTech and Moderna), it is not clear whether the AstraZeneca vaccine, which has had a troubled history with regulators, could even be cleared in time to meet USA needs. The Biden administration and the Department of Health and Human Services facilitated the change in management.
So far, none of the Johnson & Johnson doses made by Emergent have been released by the F.D.A. for distribution. Moreover, the contamination is a point of corporate embarrassment for both Johnson & Johnson and Emergent, after both lobbied the government for vaccine production contracts. The company confirmed it was taking tighter control of the production process.
Emergent said the quality control systems in place worked as planned and it will continue to work toward FDA approval. But the Emergent BioSolutions plant at the heart of the issue has faced scrutiny for its shortcomings from federal regulators before.
Johnson & Johnson's single-shot coronavirus vaccine was approved for emergency use in the U.S. at the end of February, becoming the third vaccine to be authorised by the FDA (in addition to the Pfizer/BioNTech and Moderna COVID-19 vaccines). Both actions came after a New York Times investigation into how the company had gained outsize influence over the repository.