The federal government has ordered Johnson & Johnson to fully take over its vaccine production at the factory, an administration official told CNN on Saturday. The company has confirmed that it is more strictly controlling the production process.
The official said the Emergent BioSolutions plant, which produced doses of Johnson & Johnson’s vaccine as well as a vaccine for AstraZeneca, will now only produce J&J vaccines. The Department of Health and Human Services has instructed that the AstraZeneca vaccine will now be produced at another plant, although the official did not specify where to go.
“Johnson & Johnson assumes full responsibility for the manufacture of the drug for its COVID-19 vaccine at the Emergency BioSolutions Inc. Bayview plant,” the company said in a statement to CNN.
“Specifically, the company is adding dedicated leaders for operations and quality, and increasing the number of manufacturing, quality and technical operations personnel to work with the specialists already at Emergent.”
And AstraZeneca has confirmed that the vaccine, AZD1222, at the Emergent plant in Baltimore, will no longer be manufactured.
“AstraZeneca is working with the Biomedical Advanced 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 this effort, and in full cooperation with “The U.S. government will relocate AstraZeneca, a production of AZD1222 vaccine medicine 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 U.S. government to create an alternative manufacturing site for AZD1222 for home remedies.”
“AstraZeneca and the US government continue to work closely together to support agreed plans for the development, production and full delivery of the vaccine.”
AstraZeneca has not yet asked the FDA for the use of the vaccine for emergency use, but like other coronavirus vaccine manufacturers, it has done so early in anticipation of winning the EUA.
None of the infected Johnson & Johnson vaccines were packaged or shipped, and the operation of the plant was not approved. All J&J vaccine used in the USA was manufactured in a factory in the Netherlands.
Government officials stressed that the discovery of the contamination shows that the meticulous inspection and quality control systems manufactured by vaccines work as designed. They characterized movements to strengthen surveillance at the Emergent plant as standard for such an event, noting that pollution, although unusual and undesirable, is not an extraordinary event.
One source familiar with the situation told CNN that it is “not so uncommon” for the pharmaceutical industry to throw away quantities of vaccines.
While Emergent manufactures the vaccine material itself, it sends the product to other plants to be placed in vials for use – a process known as filling and finishing. Every step of this process is subject to FDA inspection and authorization.
A source familiar with Johnson & Johnson’s manufacturing process says the loss of 15 million potential doses of Johnson & Johnson’s vaccine is not a major setback.
“Once the plant is up and running again, the way this particular vaccine is made in these large quantities should not be a major setback. It should be a setback of just a few weeks,” the source told CNN said. .
And another source told CNN that Johnson & Johnson successfully produced 115 million other doses of the vaccine in the Emergent plant.
J&J has reached its target of delivering 20 million doses of its vaccine to the US by the end of March and says it is aiming to deliver 100 million doses by the end of May.