Emergent threw nearly 400 million Covid-19 vaccine doses into Baltimore debacle, House report says – Endpoints News
Emergent threw nearly 400 million Covid-19 vaccine doses into Baltimore debacle, House report says – Endpoints News

Emergent threw nearly 400 million Covid-19 vaccine doses into Baltimore debacle, House report says – Endpoints News

The exact number of doses lost in the Emergent BioSolutions accident at its Baltimore facility has never been accurately determined. But one recently report from US House select subcommittee on the coronavirus crisis says the company may have destroyed nearly 400 million doses of Covid-19 vaccines after failing to comply with quality standards.

The report came to the decision via requests for internal communication between Emergent leaders, which the subcommittee claims included efforts to conceal evidence of contamination in “an attempt to avoid oversight by government authorities.”

“Despite big red flags at their vaccine factory, Emergent executives swept these issues under the rug and continued to pull in taxpayer dollars,” the rep said. Carolyn Maloney (D-NY) in a statement. “Ultimately, our report shows that Emergent’s manufacturing flaws and deceptive tactics led to the destruction of millions of doses of desperately needed vaccines. Emergent’s business practices are simply unacceptable, and I urge the federal government to carefully consider future contracts in the light of Emergent failure. “

Originally, it was said that between 75 million and 85 million doses of drug substance were destroyed after contamination. The report notes that 400 million doses were destroyed between April 2021 and August 2021. Emergently concealed the evidence, the report claims, by removing quality assurance holders from J&J batches, indicating that the containers had quality problems, in an attempt to avoid drawing attention from the FDA. inspectors. Emergency personnel were concerned that the Department of Health and Human Services became too involved in its operations following the AstraZeneca-J & J merger.

The report also says that Emergent entered into contracts with the two pharmacies despite being aware that the technical operation was not for snuff for at least a few years.

“Our risk is high!” A note from a senior director of quality said at one point. “We lack commercial GMP compliance maturity.”

The team at Emergent maintains that there is nothing new in the report, and disputes the statement that 400 million doses of the vaccine were found useless for me, citing the difficulties involved in estimating the dose equivalent of drug that does not has completed the manufacturing process.

“Equating these quality control actions with a ‘discarded dose’ figure shows a lack of understanding of the bio-manufacturing process,” announcement said.

CDMO maintains that it never knowingly misled the FDA or any of the partners involved in the manufacturing process. It also said that the first thing it heard about the subcommittee’s report was through the media.

“While it is important to analyze past decisions to inform future plans – we must do so in the right context and avoid the temptation of Monday morning quarterback in favor of what we know today,” the statement said. “Emergent and our government partners tried to compress the development and upscaling of drug manufacturing processes, which usually take years, to a few months. We were always transparent with our public and private partners about our process and capabilities and often offered BARDA, J&J and AstraZeneca staff welcome to the place daily. “

The report says President Donald Trump’s administration was aware of shortcomings that the company had highlighted at the Bayview site when it was awarded $ 628 million in funding back in May 2020. AstraZeneca staff raised concerns with Emergent in July 2020, noting that the site was not prepared for commercial production, and internal J&J communications said pharma was unclear whether Emergent would be good to go once the game is played.

“I say very loudly that this work is NOT CGMP compliant. And a direct regulatory risk,” an external consultant told Emergent in November 2020.

The report also found that inexperienced staff and high turnover led to vaccine contamination as the staff working were not properly trained and had little previous pharma experience.

In February, Emergent announced that its troubled Bayview plant would receive a $ 100 million upgrade, as it began making planned upgrades early and is expected to be back in operation in Q2 2022. The work will allow for “additional non-pandemic work,” carried out in Bayview down the road, ”said CEO Bob Kramer, helping to support the strengthening of J & J’s supply chain.

Right now, Emergent has a delivery deal for Sandoz’s generic Narcan and plans to launch a live typhoid and cholera vaccine. It also has a supply agreement with the U.S. government for its anthrax vaccine, the drug that started the company’s relationship with the government years ago.

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