Emergent CEO: J&J vaccine production could resume in days

Emergent BioSolutions could resume manufacturing doses of Johnson & Johnson’s coronavirus vaccine “within a matter of days,” the company’s CEO Robert Kramer told a House panel Wednesday.

Democratic lawmakers on the House Coronavirus Crisis Subcommittee pressed Kramer on Emergent’s ability to fix a host of manufacturing issues identified by a Food and Drug Administration (FDA) inspection of its Baltimore facility in April. 

At least one of those issues led to the contamination of 15 million J&J doses with ingredients from AstraZeneca’s vaccine, which the company was also manufacturing at the time. 

As a result, the FDA paused production and essentially quarantined the remaining doses on hand to conduct thorough quality checks. The Biden administration also ordered AstraZeneca to find a new manufacturing partner.

There are more than 100 million doses of Johnson & Johnson’s vaccine on hold, Kramer said, disclosing for the first time just how much of the vaccine has been affected. 

Kramer acknowledged that unsanitary conditions, including mold, were present at the facility, and that staff was inadequately trained. He said the company has been in communication with the FDA and is close to correcting the issues cited by the agency. 

“We have made significant progress against all of those commitments, we are very close to completing them, and I would expect we would be in a position to resume production within a matter of days,” Kramer said.

If that were the case, the resumption of manufacturing would be a major boon to the U.S. vaccination effort. The nation is relying only on two-dose vaccines from Moderna and Pfizer-BioNTech, as supplies of the single-dose J&J vaccine have essentially dried up.

“Emergent’s failures are disappointing precisely because these vaccines are so effective. Because the company was unable to deliver, the vaccinations of millions of people around the world have been delayed, putting their lives at needless risk,” subcommittee chairman James Clyburn (D-S.C.) said during the hearing.

Kramer testified that Emergent’s own quality control practices discovered the contamination of the Johnson & Johnson doses. But when pressed by Rep. Bill Foster (D-Ill.), he acknowledged that it was actually identified by a Johnson & Johnson lab in the Netherlands.

Emergent’s founder and executive chair Fuad El-Hibri noted that AstraZeneca, Johnson & Johnson and the federal government’s Biomedical Advanced Research and Development Authority all were aware of the facility’s shortfalls prior to entering into manufacturing partnerships. 

But the Maryland plant was more prepared than other government-contracted facilities, and the need to quickly scale up vaccine manufacturing for the pandemic outweighed other concerns. 

“Everyone went into this with their eyes wide open, that this was a facility that had never licensed a product before, it’s a facility that although not in perfect condition, far from it, it’s the facility that had the highest level of state of readiness,” El-Hibri said. 

El-Hibri also denied that the relationship between the company and Robert Kadlec, the Trump administration’s former Assistant Secretary for Preparedness and Response, led to the awarding of the $628 million contract.

Kadleck was a consultant for Emergent before joining the administration.

“This is simply not true,”  El-Hibri told the panel. “Emergent’s relationship with Dr. Kadlec was appropriate. And Emergent’s contracts with the U.S. Government, including those associated with the COVID-19 response, have all been subject to standard government contracting procedures, overseen by independent career government contracting officers.”

Documents released by the subcommittee ahead of the hearing showed that the company had received numerous warnings about its potential manufacturing problems but did not take action. 

The federal government has paid Emergent more than $271 million in taxpayer money, but the FDA has not yet released any doses of the J&J vaccine. 

Committee Republicans largely blamed the FDA for holding on to the doses and contributing to the current J&J shortage, as Emergent executives said they had not been contaminated. 

When not trying to change the subject to conspiracy theories about the origin of the coronavirus, like Anthony Fauci funding a Chinese lab that genetically engineered the virus, Republicans also defended the company.

“You are a reputable company that has done yeoman’s work to protect this country in biodefense!” said Rep. Mark Green (R-Tenn.). “So you gave your folks a bonus for their incredible work.”