With Johnson & Johnson's COVID-19 vaccine rollout off to a slower than expected start, the recent news that millions of doses were ruined in a production error came as a rude awakening. But the Emergent BioSolutions plant at the heart of the issue has faced scrutiny for its shortcomings from federal regulators before.
An FDA investigator last April discovered improper training, record keeping, testing procedures and more at Emergent BioSolution's Baltimore Bayview facility, the Washington Post reports. The inspection came just two months before the CDMO snared an eye-popping $628 million deal from the U.S. government to scale up production capacity in hopes of supplying "tens to hundreds of millions" of COVID-19 vaccine doses through 2021. The company has partnered with J&J and AstraZeneca for their U.S. coronavirus vaccine supply chains.
Some employees at the Bayview plant hadn't been properly trained, the investigator claimed, according to the Post. Records hadn't been secured and testing procedures weren't being followed. Meanwhile, the measures Emergent put in place to “prevent contamination or mix-ups” had come up short, the investigator said.
Earlier this week, The New York Times reported that up to 15 million doses of Johnson & Johnson's COVID-19 vaccine had been ruined early in the production process after workers at Emergent's Baltimore plant mixed up vaccine ingredients. The mistake happened weeks ago, and none of the doses were distributed. 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.
Emergent performs "rigorous" quality checks throughout the vaccine manufacturing process, a company spokesperson told Fierce Pharma over email. "Through these checks, a single batch of drug substance was identified that did not meet specifications and our rigorous quality standards. We isolated this batch and it will be disposed of properly."
The episode shows that Emergent's quality control systems are working, he said. "Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process," he said.
Regarding the J&J mix-up, "it wasn't the case where an ingredient from one vaccine contaminated or impacted the other," Emergent CEO Robert Kramer said in an interview with CNBC's Meg Tirrell. "It was more simply the fact that one production run, one batch of product, was determined to be inconsistent with our quality specifications."
The New York Times had reported that Emergent employees mixed up J&J's and AstraZeneca's vaccines.
Emergent's Bayview plant is still waiting on an FDA manufacturing green light, though the company has already been producing millions of doses and shipping them to J&J's fill-finish partner Catalent, which itself snared authorization last week.
All told, J&J's early vaccine rollout has been slower than expected in the U.S. The drugmaker on Wednesday said it had met its goal to deliver 20 million doses by the end of March. According to the Centers for Disease Control and Prevention, around 7.9 million doses had been delivered to states as of Thursday.
Meanwhile, Anthony Fauci, chief medical advisor to President Joe Biden, admitted it was "really quite unfortunate" that 15 million doses could no longer be used. He said the response shows the system is working.
"You do have checks and balances, and you see that, and that's the reason why the good news is that it did get picked up," Fauci said in an interview on CBS Good Morning.
As part of that response, the FDA may send an inspection team to review Emergent's Bayview facility, The Wall Street Journal reported Friday, citing a person close with the matter. In addition, J&J said it's sending its own experts to the site to supervise manufacturing.