- Robert Kramer, the chief executive of embattled contract drug manufacturer Emergent Biosolutions, said Thursday he takes full responsibility for the error at his company's Baltimore plant that ruined millions of doses of Johnson & Johnson's coronavirus vaccine.
- But the CEO pushed back against what he called "unfair criticism" of Emergent, describing the vaccine manufacturing task the company took on as "Herculean." Working with the U.S. government, Emergent had agreed to produce the drug substance for J&J's vaccine as well as one from AstraZeneca at the Baltimore site, known as Bayview.
- Last month, cross contamination between a component of AstraZeneca's vaccine and a batch of drug substance for Johnson & Johnson's shot forced Emergent to discard as much as 15 million doses worth of material. Kramer confirmed the specific nature of the error Thursday, contradicting a claim he made earlier this month that there was no cross-contamination between the two vaccines. In an email, a spokesperson said Kramer misspoke.
Emergent's Bayview facility is in limbo, with production shut down at the FDA's request. Tens of millions of already made doses of J&J's vaccine have been stockpiled, according to Bloomberg, awaiting for the agency to authorize their release.
Earlier this month, FDA officials cited Emergent for breaches of manufacturing and sanitary standards at Bayview following a nine-day inspection of the site. According to the inspectors, Emergent failed to properly investigate the cross-contamination after it occurred, and hadn't sufficiently trained the employees involved.
Emergent expects to respond to the FDA's report "within days," Kramer said on Thursday's call. "If the FDA is comfortable with the approach we propose, I'm hopeful that we can soon return to producing the tens of millions of doses per month," he added.
Yet Kramer acknowledged the FDA could still require another inspection before signing off on vaccine production at the site, although the CEO doesn't expect that outcome.
Emergent's Bayview plant was supposed to be a central cog in the manufacturing of both J&J's and AstraZeneca's vaccines. Last June, the U.S. government agreed to pay up to $628 million to Emergent to build up the site's capacity, and to reserve production space for the two shots.
Manufacturing two vaccines that use similar technology at the same plant is unusual, but Kramer noted that in June it was unclear which one of them might succeed.
"It's easy to go back and second-guess these decisions that were made in the early stages of the pandemic," he said. "At the time, no one knew how fast we could get to a clinically viable vaccine and which candidates would be most successful."
While J&J has been able to deliver nearly 18 million doses of its vaccine using its authorized manufacturing facility in the Netherlands, Emergent was meant to handle much of the U.S. supply. With production shuttered, availability of J&J doses will likely be constrained in the near future, even after health regulators cleared vaccinations to resume following a review of safety reports of a rare blood clotting syndrome.
The U.S. government, meanwhile, is working to help AstraZeneca relocate vaccine production from the Bayview site.
Despite the disastrous mix-up at Bayview, Emergent on Thursday reported financial results for a business that's still growing strongly. Total revenues from January to March rose to $343 million from $193 million during the same period last year, and adjusted profit soared to $84 million from $300,000 a year ago.
Kramer also announced a shuffling of company leadership on Thursday. Emergent's head of manufacturing, Sean Kirk, is taking a personal leave of absence, and Adam Havey, currently executive vice president of business operations, will run Emergent's manufacturing in his stead.
Havey will work closely with Mary Oates, who joined Emergent from Pfizer last November and will now report directly to Kramer. She's overseeing the company's response to the FDA's inspection.
Finally, Syed Husain, head of Emergent's contract manufacturing division, is leaving to "pursue another opportunity." He will be replaced on an interim basis by Catherine Hanley.
The Emergent spokesperson would not comment further on whether the personnel moves had any connection to the issues at Bayview.