The federal government has ordered Johnson & Johnson to completely take over the production of vaccines at the factory, an administration official told CNN on Saturday. The company confirmed that it has taken stricter control of the production process.
The Emergent BioSolutions plant, which made doses of both Johnson & Johnson vaccines, and vaccines made for AstraZeneca, will now produce only J&J vaccines, the official said. The Department of Health and Human Services has ordered that the vaccine against AstraZeneca be now produced in another factory, although the official did not specify where.
“Johnson & Johnson assumes full responsibility for the production of the drug substance for its COVID-19 vaccine at the Emergent BioSolutions Inc. Baiviev plant,” the company said in a statement sent to CNN.
“In particular, the Company adds dedicated business and quality leaders and significantly increases the number of production, quality and technical staff to work with the Company’s experts already in Emergent.”
And AstraZeneca has confirmed that it will stop production of its vaccine, called AZD1222, at the Emergent plant in Baltimore.
“AstraZeneca is working with the Directorate for Advanced Biomedical Research and Development (BARDA) to help efforts to maximize and accelerate U.S. production of COVID-19 vaccines. As part of that effort, in full cooperation with the U.S. government, AstraZeneca will relocate drug production. for the AZD1222 vaccine from the Emergent Plant in Baltimore, Maryland, “the company said in a statement posted online.
BARDA is the HHS department that helps develop medical countermeasures for pandemics and biological attacks.
“The company will cooperate with the American government in determining an alternative place for domestic production of substances of drugs from AZD1222,” it is added.
“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 emergency use for its vaccine, but, like other manufacturers of coronavirus vaccines, it did so ahead of time in anticipation of winning the EUA.
None of the contaminated Johnson & Johnson vaccines were packaged or shipped, and the operation of the plant was therefore not approved. All J&J vaccine used in the United States is made in a factory in the Netherlands.
Government officials stressed that the discovery of contamination shows the detailed inspection and quality control systems that existed in the vaccine production plants and worked as they were designed. They characterized moves to strengthen surveillance of the Emergent plant as the standard for such a phenomenon and noted that pollution, although unusual and undesirable, was not an extraordinary event.
A source familiar with the situation told CNN that “it is not so unusual” that the pharmaceutical industry must reject batches of vaccines.
While Emergent makes the vaccine material itself, it supplies the product to other plants to put in bottles for use – a procedure known as filling and finishing. Every step of this process is subject to inspection and FDA approval.
A source familiar with the Johnson & Johnson vaccine production process said that the loss of 15 million potential doses of Johnson & Johnson vaccine is not a big hurdle.
“Once the plant is restarted, the way this special vaccine is made in these large batches, compensating for this batch should not be a big obstacle. It should be a standstill of only a few weeks,” a source told CNN.
And another source told CNN that Johnson & Johnson successfully produced 115 million other doses of its 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 the goal is to provide 100 million doses by the end of May.