Emergent Hid Quality Problems With COVID-19 Vaccines, New Report Shows

The troubled manufacturing plant Emergent BioSolutions concealed proof of quality problems at its Baltimore, Md., location just a month and a half before it told the FDA that 15 million COVID-19 vaccine doses manufactured there had been contaminated.

That’s according to a report on the coronavirus vaccine manufacturing failures of the government contractor released by House Democrats on Tuesday. The report, the result of a year-long investigation, was issued jointly by the House Committee on Oversight and Reform and the Select Subcommittee on the Coronavirus Crisis.

The 26-page report showed that just before an FDA site visit in February 2021, Emergent employees removed from Johnson & Johnson (J&J) vaccine batches quality-assurance “hold tags” that indicated the containers had a potential quality issue.

An email obtained by the committees says the tags were removed “to avoid drawing attention” from FDA investigators.

New documents also show that Emergent personnel expressed concern that the Department of Health and Human Services (HHS) was “getting too involved” following the company’s cross-contamination of the J&J and AstraZeneca vaccines in March 2021.

“Today’s report shows that Emergent profited from the pandemic while violating the public’s trust,” said Rep. Carolyn Maloney (D-N.Y.), chair of the House Committee on Oversight and Reform. “Despite major red flags at its vaccine manufacturing facility, Emergent’s executives swept these problems under the rug and continued to rake in taxpayer dollars.”

Emergent has had a turbulent few years during which it spent many months in the headlines for botching 75 million J&J COVID-19 vaccines after they were cross-contaminated with AstraZeneca’s coronavirus vaccine also produced there. The FDA then stopped operations at the facility. And in November, the troubled company lost its $600 million-plus contract with the federal government (DID, Nov. 9, 2021).

The report shows Emergent destroyed almost 400 million doses of coronavirus vaccine in total “due to poor quality control.” This is much higher than previous estimates and includes millions of vaccine doses the company destroyed after the FDA ordered a three-month halt of manufacturing activities between April and August 2021.

No contaminated doses from the facility were ever released to the public.

The report also showed that Emergent executives promoted the company’s manufacturing capabilities despite being warned of severe deficiencies.

Documents obtained by the committees reveal that before Emergent finalized manufacturing agreements with J&J and AstraZeneca, the company’s then-executive vice president of manufacturing and technical operations said privately that he had warned senior executives “for a few years” about the company’s deficient quality systems, saying that “room to improve is a huge understatement.”

Despite these warnings, though, Emergent entered into contracts with J&J and AstraZeneca to manufacture COVID-19 vaccines for $482 million and $174 million, respectively.

Internal Emergent communications unearthed by the committees show that after manufacturing began, the senior director of quality at the facility warned, “Our risk is high!” and, “we lack commercial GMP [good manufacturing practice] compliance maturity.”

Rep. James Clyburn (D-S.C.), chairman of the Select Subcommittee on the Coronavirus Crisis, said Emergent and its executives “failed the American people through the contamination of hundreds of millions of desperately-needed vaccines at a pivotal point in the pandemic. These doses were squandered despite repeated warnings from employees, outside consultants, pharmaceutical companies, and FDA regulators that the company’s manufacturing practices were unsafe and that it was unlikely to fulfill the contract.”

Emergent did not respond to a request for comment.

Read the full report here: www.fdanews.com/05-11-22-CoronavirusVaccineMfgFailures.pdf. — Suz Redfearn