The manufacturing hold at Emergent's Baltimore Bayview plant could be coming to an end — report
Maryland’s Emergent BioSolutions has been forced to sit on its own hands for more than a month after shutting down production at a Baltimore plant blasted for screwing up millions of doses of two Covid-19 vaccines. Now, with a laundry list of quality issues apparently solved, Emergent is reportedly days away from getting its lines rolling once again.
J&J is expected to announce that contamination problems at Emergent’s Baltimore Bayview plant have been resolved and production is set to resume, The Wall Street Journal reported Friday.
The deal with the FDA could free up already manufactured doses of the vaccine that have been in quarantine, and allow for the production of new ones. Doses of the vaccine have been in limbo after the FDA took over the plant in April, and Emergent announced it would cease manufacturing in light of the inspection tied to a viral vector mixup.
That was on April 16, and soon after the US saw the number of doses allocated for states fall from nearly 5 million to 785,000. California, Texas and Florida were slated to receive the doses, Reuters reported.
As a part of the arrangement, 60 million doses of the J&J jab could be cleared for use, the WSJ reports. Because the jab is single-dose, that means 60 million people are eligible to be fully vaccinated once doses become available. An additional 60 million doses of the AstraZeneca shot could become available as well, according to the WSJ, ready to vaccinate 30 million people.
The mixup wasn’t Emergent’s first. Earlier in the manufacturing process, the company was forced to trash millions of materials tied to AstraZeneca’s vaccine, something Kramer blamed on a flawed manufacturing process sent over by the drugmaker.
A Form 483 from the FDA revealed unsanitary conditions at the plant and half-hearted attempts at keeping it clean. Mold, paint chipping off the walls and unknown black and brown substances were all present, and some employees failed to decontaminate bags of waste before dragging them through the warehouse.
In an April 21 statement, Emergent said:
We deeply value the relationship we have with our manufacturing partners and with the FDA. The FDA’s feedback will help us continue to improve and strengthen the supply chain for Johnson & Johnson’s COVID-19 vaccine. While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them.
Kramer had previously offered mixed messages on what exactly happened to lead to the mixup, but clarified in front of a House subcommittee in May that J&J quality control employees at its Leiden, Netherlands facility caught the mixup. The cross contamination occurred as a result of material exiting out of a facility and coming in close vicinity with media prepared for a J&J run.