The federal government has instructed Johnson & Johnson to fully take over vaccine production at the plant, a government official told CNN on Saturday. The company confirmed that it is taking a tighter control of the production process.
The Emergent BioSolutions factory, which had been producing doses of both the Johnson & Johnson vaccine and the vaccine made for AstraZeneca, will now produce only J&J vaccines, the official said. The Department of Health and Human Services has determined that the AstraZeneca vaccine is now produced in another factory, although the official did not specify where.
“Johnson & Johnson is taking full responsibility for the manufacture of the drug substance for its COVID-19 vaccine at the Emergent BioSolutions Inc. facility in Bayview,” the company said in an emailed statement to CNN.
“Specifically, the company is adding dedicated leaders for operations and quality, and significantly increasing the number of manufacturing, quality and technical operations personnel to work with the company’s specialists who are already at Emergent.”
And AstraZeneca confirmed that it would stop manufacturing the vaccine, called AZD1222, at the Emergent Baltimore plant.
“AstraZeneca is working with the Advanced Biomedical Research and Development Authority (BARDA) to assist in the effort to maximize and accelerate the production of COVID-19 vaccines in the United States. As part of that effort, and in full cooperation with the United States Government United, AstraZeneca will relocate production of the AZD1222 vaccine drug substance at Emergent’s Baltimore, Maryland, facility, “the company said in a statement published online.
BARDA is a division of HHS that helps develop medical countermeasures for pandemics and biological attacks.
“The company will work with the United States government to identify an alternative location for the domestic production of the drug substance AZD1222,” he added.
“AstraZeneca and the US government continue to work together to support the agreed plans for the development, production and full delivery of the vaccine.”
AstraZeneca has not yet asked the FDA to authorize the emergency use of its vaccine, but, like other manufacturers of vaccines against the coronavirus, it has done so in advance, hoping to win the United States.
None of Johnson & Johnson’s contaminated vaccines have been packaged or shipped, and the operation of the factory that produced it has not been approved. The entire J&J vaccine used in the United States was produced in a factory in the Netherlands.
Government officials emphasized that the discovery of the contamination shows that the meticulous inspection and quality control systems in place at the vaccine factories worked the way they were designed. They characterized moves to strengthen supervision at the emerging plant as the standard for such an occurrence and noted that contamination, while unusual and undesirable, is not an extraordinary event.
A source familiar with the situation told CNN that “it is not so unusual” for the pharmaceutical industry to have to discard batches of vaccines.
While Emergent makes the vaccine material itself, it sends the product to other factories to be put into bottles for use – a process known as filling and finishing. Each step of this process is subject to FDA inspection and authorization.
A source familiar with the Johnson & Johnson vaccine manufacturing process said the loss of 15 million potential doses of the Johnson & Johnson vaccine is not a major setback.
“Once the plant is back up and running, the way this particular vaccine is made on these large batches, compensating for that batch should not be a major setback. It should be a setback of just a few weeks,” the source told CNN .
And another source told CNN that Johnson & Johnson has successfully produced 115 million other doses of its vaccine at the emerging plant.
J&J has met its goal of providing the United States with 20 million doses of its vaccine by the end of March and says it aims to deliver 100 million doses by the end of May.