A government official told CNN on Saturday that the federal government has instructed Johnson & Johnson to completely take over the vaccine production at the plant. The company confirmed that it is strictly controlling the production process.
The official said that the Emergent BioSolutions plant produces both Johnson & Johnson vaccines and AstraZeneca vaccines, and now only Johnson & Johnson vaccines are produced. The Ministry of Health and Human Services instructed that the AstraZeneca vaccine will now be produced in another factory, although the official did not specify.
The company said in a statement emailed to CNN: “Johnson & Johnson will take full responsibility for its COVID-1
“In particular, the company will add dedicated operations and quality managers, and significantly increase the number of manufacturing, quality and technical operations personnel, working with the company’s experts already in Emergent.”
AstraZeneca confirmed that it will stop producing the vaccine, called AZD1222, at its emergency plant in Baltimore.
“AstraZeneca is working with the Biomedical Advanced Research and Development Agency (BARDA) to assist in maximizing and accelerating the U.S. efforts to produce COVID-19 vaccines. As part of this effort, in full cooperation with the U.S. government, AstraZeneca will relocate its emergency facility in Baltimore, Maryland to produce AZD1222 vaccine bulk medicine.”
BARDA is a department of HHS that helps develop medical countermeasures against epidemics and biological attacks.
It added: “The company will work with the U.S. government to find an alternative location for domestic API production of AZD1222.”
“AstraZeneca and the U.S. government continue to work closely to support the agreed vaccine development, production and full delivery plan.”
AstraZeneca has not yet requested an emergency use authorization for its vaccine from the US Food and Drug Administration, but like other coronavirus vaccine manufacturers, AstraZeneca has been striving for EUA honors.
None of the contaminated Johnson & Johnson vaccines was packaged or shipped, and the factory’s production operations were not approved. All Johnson & Johnson vaccines used in the United States are produced in a factory in the Netherlands.
Government officials emphasized that the discovery of this contamination indicates that the vaccine manufacturer has adopted a well-designed inspection and quality control system. They took measures to strengthen emergency factory supervision as the standard for such incidents, and pointed out that although pollution is uncommon and unqualified, it is not a rare incident.
A source familiar with the situation told CNN that it is “not uncommon” for the pharmaceutical industry to have to discard batches of vaccines.
When Emergent produces its own vaccine materials, it will ship the products to other factories and put them in vials for use-a process called filling and finishing. Each step of this process needs to be inspected and authorized by the FDA.
A source familiar with the Johnson & Johnson vaccine production process said that the loss of 15 million doses of the potential dose of Johnson & Johnson vaccine is not a major setback.
A source told CNN: “Once the factory resumes operations, this special batch of vaccine production method will not be a major setback. This should be a setback in just a few weeks.”
Another source told CNN that Johnson & Johnson has successfully produced 115 million other doses of vaccines in emergency factories.
Johnson & Johnson achieved its goal of providing 20 million doses of vaccine to the United States by the end of March and stated that its goal is to provide 100 million doses of vaccine by the end of May.