BALTIMORE (WJZ) — Robert Kramer, the CEO of Emergent BioSolutions, said in an interview with CNBC that he wanted to clear up “misunderstandings and misconceptions” about what happened at the company’s Baltimore facility last month when millions of Johnson & Johnson vaccine doses were reportedly ruined.
“As unfortunate as it is to occasionally have [an] out-of-spec product, it does happen. The good thing is our quality-control systems caught it as designed,” Kramer said.
He also told CNBC he disputes published reports that the problem stemmed from employees mixing up ingredients from Johnson & Johnson and AstraZeneca vaccines, which are both made at the Baltimore Bayview plant.
“It isn’t the case or wasn’t the case where an ingredient from one vaccine contaminated or impacted the other,” Kramer said.
When pressed, he declined to provide specifics about what happened.
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“It was an out of specification result for one batch of product,” he said.
Kramer also would not reveal how many doses were spoiled. According to published reports, the number is 15 million.
“I’ve seen as well where that has been equated to 15 million doses. All I can say is that’s one batch,” Kramer said.
15 million doses would be more than enough to vaccinate everyone in Maryland—and enough to inoculate 7% of the United States, according to Tinglong Dai, an associate professor with Johns Hopkins’ Carey Business School who says Emergent needs to provide a full accounting of what happened.
Dai is a healthcare analytics expert who has closely focused on management issues during the vaccine rollout.
“They should do a better job of explaining what really happened,” Dai told WJZ Investigator Mike Hellgren. “We really need full transparency. …The very first step they can take is to provide a very detailed account of what happened.
Still, Dai said he is confident the vaccines currently in use are safe.
“We should have every reason to be confident in the quality coming from Johnson & Johnson, Moderna and Pfizer,” he said. “I have no doubt that we’ll be having high quality, safe vaccines.”
None of the doses made in Baltimore has been used, as the facility still needs FDA approval.
The Biden Administration was asked Thursday why they failed to notify the public about the mix up, which first came to light in The New York Times.
White House press secretary Jen Psaki said they learned last week about the issue.
“I think it’s important for people to remember that this plant has not been FDA approved. It’s still going through a rigorous review,” Psaki said. “And J&J is of course working through that process to bring the facility online and gain authorization. …So [Health and Human Services] updated us. In fact, this is probably the process working as it should. HHS updated us on J&J’s manufacturing, including where things stood with the facility, at the point where they learned about the issue. It wasn’t going to impact our supply, it wasn’t going to impact the supply to the American people. And of course, J&J is working through this with the FDA. So we’d certainly refer to them on the process.”
President Joe Biden abruptly canceled a visit to the Baltimore facility last month.
White House Press Secretary says White House is more appropriate venue for the Johnson & Johnson/Merck meeting than Baltimore; addresses NYT article and says government undertaking review of national stockpile. @wjz
— Mike Hellgren (@HellgrenWJZ) March 8, 2021
Baltimore City and state health leaders tell WJZ the issue will not cause vaccine supply problems in the short term.
“I think the bigger disruption is in the trust of the public,” Dai said. He added that he hopes what happened does not add to any vaccine hesitancy.
Here is Emergent’s full statement to WJZ about the incident:
“At Emergent, safety and quality are our top priorities. Our Bayview facility has been designed and validated to meet all current Good Manufacturing Practices. In addition, 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. We isolated this batch and it will be disposed of properly. Importantly, the quality control systems worked as designed to detect and isolate this single batch. Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process. We continue to manufacture in support of our customers and the U.S. government, and we remain confident in our ability to meet the FDA requirements. We are very proud of the role the Emergent team is playing in support of the response to COVID-19 and look forward to continuing to do our part to help stem this pandemic.”