Emergent CEO Anticipates Resuming Bayview Production of J&J Vaccine Within Days

Emergent BioSolutions CEO Robert Kramer said Wednesday that the FDA is currently assessing whether to allow the release of more than 100 million Johnson & Johnson (J&J) vaccine doses that were produced at Emergent’s beleaguered Bayview, Md., facility during the company’s highly publicized cross-contamination incident there earlier this year.

Kramer and Emergent’s Executive Chairman Fuad El-Hibri faced questions from visibly frustrated lawmakers on the House Select Subcommittee on the Coronavirus Crisis yesterday related to a March mix-up that led to 15 million J&J vaccine doses being discarded after it was determined they had been exposed to materials meant for the AstraZeneca (AZ) vaccine (DID, April 6).

“Importantly, our internal quality control procedures identified the out-of-specification in the contamination. None of that material left our control,” Kramer said when apologizing to the lawmakers for the mix-up.

The CEO said that the facility has made significant headway on its commitments to address the observations outlined in the FDA’s April Form 483 (DID, April 22) and is very close to completing them. Based on that, Kramer said he expects the site will be able to resume production “within a matter of days.” However, even when production restarts, the facility will still need the FDA’s authorization to ship any doses for use.

Committee Chairman James Clyburn (D-S.C.) grilled Kramer, asking if there was any excuse for the observations listed on the agency’s 483.

Kramer detailed the company’s 483 response, currently under evaluation by the FDA (DID, May 17). Emergent’s plan involves “significant and robust remediation plans and corrective actions,” he said. According to the executive, it includes significant improvements to the facility’s sanitization processes, personnel and material flow, a number of training programs for all employees on viral contamination risk and improvements to good manufacturing practices.

The FDA has declined comment on when it might authorize the Bayview plant for vaccine shipments and whether Emergent’s remediation plan has been completed.

Kramer told the lawmakers that the facility faced a significant challenge when it began preparing to produce COVID-19 vaccines in April 2020, when it was asked to make both AZ’s and J&J’s vaccines, and to do so at unusual speed.

“When we began this work … we were challenged, along with our network of partners — AZ, J&J and the U.S. government and [HHS’ Biomedical Advanced Research and Development Authority (BARDA)] — to very quickly tech transfer in these two candidates, scale them up and be in a position to make tens of millions if not hundreds of millions of vaccines,” he said. “That process typically takes one to two years, and we were being asked to do that in a period of months.”

Rep. Bill Foster (D-Ill.) questioned Kramer on the plant’s previous citations from the FDA and other auditors as well as the March incident, asking if he was aware of the risk of cross-contamination before the doses were ruined. Kramer responded that there is a “well-known risk” of cross-contamination if precautions are not taken but claimed that the facility acted properly in establishing safeguards to avoid contaminating doses.

“It is a well-known risk that if the precautions are not taken, there is a likelihood of a cross-contamination. We took that risk seriously, we took all appropriate precautions to prevent that from happening, and unfortunately one incident did result in a cross-contamination,” he said.

Democrats also grilled the executives on federal contracts the company received both during and prior to the pandemic, as well as executive bonuses given while the Bayview issues played out and stock trading by Kramer before the plant’s problems were made public.

Democrats alleged the company’s COVID-19 vaccine manufacturing contract awarded last year was inappropriately pushed for by Robert Kadlec, a former Emergent consultant and Trump administration assistant secretary for preparedness and response, but Kramer denied that there was any untoward influence involved.

“I’m not aware of [Kadlec’s] direct involvement in the contract. All of our negotiations and discussions with the government were with [BARDA] … which awarded the contract,” Kramer said. “Emergent’s contracts with the U.S. government have all been subject to standard government contracting procedures overseen by independent career government contracting officers.”

Rep. Raja Krishnamoorthi (D-Ill.) took the company executives to task for failing to deliver a single vaccine dose to the American people despite receiving hundreds of millions in government funding. The lawmaker placed large and visible cards that underscored the $628 million the drugmaker received in 2020 vaccine contracts from the federal government alongside the $5.6 million compensation Kramer received last year. Asked by Krishnamoorthi to turn over a large chunk of his compensation to the American taxpayers, Kramer refused.

Both Kramer and El-Hibri committed to testifying again, at the request of Rep. Carolyn Maloney (D-N.Y.), once lawmakers finish their investigation into the $628 million federal contract with the company. — James Miessler