The federal government has ordered Johnson & Johnson to take over the production of vaccines at the plant, a government official told CNN on Saturday. The company has confirmed that it is taking stricter control over the production process.
The Emergent BioSolutions plant, which has delivered doses of both the Johnson & Johnson vaccine and a vaccine made for AstraZeneca, will now produce only J&J vaccines, the official said. The Department of Health and Human Services has ordered that the AstraZeneca vaccine be now produced at another factory, although the official did not specify where.
“Johnson & Johnson assumes full responsibility for the manufacture of the COVID-19 vaccine at Emergent BioSolutions Inc. Bayview,” the company said in an email to CNN.
“Specifically, the Company adds dedicated leaders for operations and quality and significantly increases the number of production, quality and technical operations personnel to collaborate with the Company’s specialists already at Emergent.”
AstraZeneca also confirmed that it will stop manufacturing the vaccine, called AZD1222, at the emerging plant in Baltimore.
“AstraZeneca is working with the Authority for Advanced Biomedical Research and Development (BARDA) to assist in the effort to maximize and accelerate US production of COVID-19 vaccines. As part of this effort and in full cooperation with the US government, AstraZeneca will move production AZD1222 vaccine from the Emergent facility in Baltimore, Maryland, “the company said in a statement posted online.
BARDA is a division of HHS that helps develop medical countermeasures for pandemics and biological attacks.
“The company will work with the US government to identify an alternative location for domestic production of AZD1222 drugs,” she added.
“AstraZeneca and the US government continue to work closely together to support the agreed plans for the full development, production and delivery of the vaccine.”
AstraZeneca has not yet applied to the FDA for authorization to use its vaccine urgently, but, like other manufacturers of coronavirus vaccines, has done so ahead of time, pending the USA’s win.
None of the contaminated Johnson & Johnson vaccines had been packaged or delivered, and the operation of the factory that had done so had not been approved. All J&J vaccine used in the USA was made at a factory in the Netherlands.
Government officials pointed out that the discovery of the contamination shows that meticulous inspection and quality control systems in vaccine factories have functioned as designed. They characterized the movements to strengthen surveillance at the emerging plant as a standard for such an occurrence and noted that contamination, although 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 give up batches of vaccines.
While Emergent makes the vaccine material on its own, it delivers the product to other plants to be put into vials for use – a process known as filling and finishing. Each stage of this process is subject to FDA inspection and authorization.
A source familiar with the Johnson & Johnson vaccine manufacturing process said that losing 15 million potential doses of Johnson & Johnson vaccine is not a major obstacle.
“Once the plant is back in operation, the way this particular vaccine is made in these large batches, compensating this batch should not be a major obstacle. It should be an obstacle for only a few weeks,” the source said for CNN. .
Another source told CNN that Johnson & Johnson successfully produced another 115 million doses of vaccine at the Emergent plant.
J&J has met its goal of delivering 20 million doses of its vaccine to the United States by the end of March and says it is on track to deliver 100 million doses by the end of May.