Johnson & Johnson's single-shot coronavirus vaccine was approved for emergency use in the United States at the end of February, becoming the third vaccine to be authorised by the FDA (in addition to the Pfizer/BioNTech and Moderna COVID-19 vaccines).
A spokesman for Emergent declined to comment, except to say that the company would continue making AstraZeneca doses until it received a contract modification from the federal government. The company has partnered with J&J and AstraZeneca for their US coronavirus vaccine supply chains.More news: Dutch stop giving AstraZeneca vaccine to under-60s pending review
Some employees at the Bayview plant hadn't been properly trained, the investigator claimed, according to the Post.
Experts in vaccine manufacturing said that in the past, the F.D.A. had a rule to prevent such mishaps by not allowing a plant to make two live viral vector vaccines, because of the potential for mix-ups and contamination.
The U.S. government on Saturday stopped a Baltimore manufacturing plant that ruined 15 million doses of Johnson & Johnson's JNJ.N COVID-19 vaccine from making the vaccine developed by AstraZeneca Plc, the New York Times reported. Federal investigators chalked it up to "human error", The Times reported, while Emergent itself flagged the issue and reached out to the FDA, according to J&J.More news: Fully vaccinated people can fly in US
"There are rigorous quality checks throughout our vaccine manufacturing processes, and through these checks a single batch of drug substance was identified that did not meet specifications and our rigorous quality standards", an Emergent statement said.
Emergent performs "rigorous" quality checks throughout the vaccine manufacturing process, a company spokesperson told Fierce Pharma over email.
Had this portion of ingredients been approved it would have contributed to vaccine production. Last month, a batch of Johnson & Johnson "drug product " failed quality control and was taken out of production, both J&J and Emergent have said. Instead, the batch was disposed of.More news: United States agrees to begin indirect talks on Iran's nuclear program