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Tuesday, June 15, 2021

U.S. Taps Johnson & Johnson to Run Troubled Vaccine Plant

So far, not one of the Johnson & Johnson doses made by Emergent have been launched by the F.D.A. for distribution. Officials have stated it could take weeks to type out whether or not different batches of vaccine had been contaminated and for F.D.A. inspectors to decide whether or not the Emergent plant could be cleared to launch any doses that it has made.

The performing F.D.A. commissioner, Dr. Janet Woodcock, stated in an announcement on Saturday that the company “takes its responsibility for helping to ensure the quality of manufacturing of vaccines and other medical products for use during this pandemic very seriously.”

But she made it clear that the last word accountability would relaxation with Johnson & Johnson, saying: “It is important to note that even when companies use contract manufacturing organizations, it is ultimately the responsibility of the company that holds the emergency use authorization to ensure that the quality standards of the FDA are met.”

In one other association brokered by the Biden administration final month, Johnson & Johnson is now working with Merck, one of many world’s greatest vaccine producers. Officials stated Merck would assist with administration of the Baltimore plant.

Emergent’s Baltimore plant is one among two which are federally designated as “Centers for Innovation in Advanced Development and Manufacturing” and had been constructed with taxpayer help. Last June, the federal government paid Emergent $628 million to reserve area there as a part of Operation Warp Speed, the Trump administration’s fast-track initiative to develop coronavirus vaccines.

Johnson & Johnson and AstraZeneca each contracted with Emergent to use the area. Both vaccines are so-called dwell viral-vector vaccines, which means they use a modified, innocent model of a unique virus as a vector, or service, to ship directions to the physique’s immune system. The Johnson & Johnson vaccine is run in a single dose, AstraZeneca’s in two doses.

Experts in vaccine manufacturing stated that previously, the F.D.A. had a rule to forestall such mishaps by not permitting a plant to make two dwell viral vector vaccines, due to the potential for mix-ups and contamination.

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