WASHINGTON – A senior federal pandemic official warned last June that Emergent BioSolutions, the government contractor that spilled millions of doses of Covid-19 vaccines for contamination last month, had insufficiently trained staff and had quality control issues.
A copy of the official’s assessment received from the New York Times named “major risks” involved in the manufacture of vaccines developed by both Johnson & Johnson and AstraZeneca at Emergent’s Bayview facility in Baltimore Emergent leaves.
The assessment, which was not made public, was based in part on a visit to the facility just days after the Emergent government placed an order valued at up to $ 628 million primarily to set up their factories to manufacture coronavirus Prepare vaccines as part of Operation Warp Speed.
Solving the problems “requires significant effort” and the company “needs close monitoring,” says the report written by Carlo de Notaristefani, a manufacturing expert who oversees the production of Covid-19 vaccines for the federal government has since last May. Although marked as draft, federal officials said the report was considered final.
Ten months after his report, the facility has become a major problem for the team named by President Biden to oversee the response to the pandemic. The Times reported Tuesday on a number of quality control issues that were reported in audits and investigations by AstraZeneca, Johnson & Johnson, two federal agencies, and Emergent’s own quality assessors.
Federal officials ordered major changes to the facility after it was announced late last month that Emergent had to dump between 13 and 15 million doses of Johnson & Johnson’s vaccine. It’s not clear what will happen to another 62 million doses of the factory-made vaccine, or whether Johnson & Johnson will be able to deliver the 24 million doses it has promised the federal government by the end of the month.
To date, the Food and Drug Administration has not certified the factory for the distribution of cans for public use, and the agency is not expected to do so until it does a thorough review, which can take weeks.
When asked about the June report, a company spokesman said on Wednesday evening, “Emergent’s top priority remains to strengthen the supply chain for Johnson & Johnson’s much-needed Covid-19 vaccine.”
Although some states are concerned that Emergent’s problems are causing the federal government to ship fewer doses than it promised, Biden government officials insist that the government still has enough supplies from the other two federally-licensed vaccine manufacturers – Pfizer-BioNTech and Moderna – to cover the vast majority of the country’s approximately 260 million adults.
Even so, Thursday the Pentagon blamed the emergent mix-up for the inability to deliver cans to military families overseas.
And federal officials are concerned about the impact on global vaccine supplies if problems at the plant are not resolved.
AstraZeneca was expected to meet most of global needs, but security concerns have turned those plans on their head. British officials said Wednesday that anyone under the age of 30 should not take the AstraZeneca vaccine, and authorities in the European Union said they had found a “possible link” between the vaccine and rare but worrying blood clots. That makes the Johnson & Johnson vaccine more important, experts say.
Emergent was forced to discard the Johnson & Johnson cans after controls revealed contamination with a virus used in the manufacture of the AstraZeneca vaccine. An investigation is currently underway, but federal and former company officials suspect the property was tainted because an employee from AstraZeneca’s plant section moved to Johnson & Johnson’s without showering and taking other precautions.
Between October and January, Emergent dumped five lots of the AstraZeneca vaccine – each equivalent to two to three million doses – because of contamination or suspected contamination, The Times reported Tuesday.
By giving Emergent a key role in responding to coronavirus, the government was counting on the company to deliver on a promise made more than eight years earlier. To ensure a domestic supply of vaccines in a pandemic, the Emergent government placed a US $ 163 million contract in 2012 to prepare the Baltimore plant for mass production in a crisis.
However, Mr de Notaristefani wrote that Emergent had mainly used the site for smaller development projects. In order to manufacture large quantities of Covid-19 vaccines, the company needs to “step up” its quality controls, which requires “significant resources and commitment,” he wrote.
His report was based in part on a visit to the plant on June 4 last year, information from the company and discussions with the Biomedical Advanced Research and Development Authority, the federal agency that placed the manufacturing contract with Emergent.
It is unclear what action, if any, the Trump administration took, or whether the Biden administration reviewed the results before the recent problems emerged.
Mr de Notaristefani, a former executive at two large pharmaceutical companies, cited “significant” staffing problems and wrote that plans to increase staff were “insufficient to enable the company to produce at the required speed”.
He also noted that audits by the FDA and individual companies hiring Emergent “highlighted the need for extensive staff training and strengthening the quality function.”
Nevertheless, he wrote: “The organization has the necessary experience / competence” to enlarge its production. He wrote that “the management is knowledgeable and appears confident” and that with adequate government oversight, “risks can be mitigated”.
At the time of the visit, Emergent was also planning to manufacture a third Covid-19 vaccine developed by Novavax. Since then, this company has partnered with another manufacturer. “Offloading the Novavax program to another facility will also help ease the burden on Emergent Bayview,” wrote de Notaristefani.
Emergent is a longtime federal entrepreneur in the biological defense field. Sales of its anthrax vaccines accounted for nearly half of Strategic National Stockpile’s annual budget of half a billion dollars for most of the past decade, The Times reported last month. This left the government with less money on items needed during a pandemic, and last year the lack of basic health care in inventory became a symbol of the government’s botched coronavirus response.
Although the original federal contract for the Baltimore plant required Emergent to demonstrate large-scale manufacture of a pandemic influenza vaccine – designated by health officials as a pressure test of its capabilities – Emergent had yet to do so, The Times reported Tuesday. The company risked default on the original contract, which set a deadline of June 2020. The company also has separate agreements with the two vaccine makers valued at more than $ 875 million.
In an effort to solve the factory’s problems, federal officials have simplified Emergent’s mission by limiting themselves to just making Johnson & Johnson’s vaccine and forcing AstraZeneca to relocate their production lines. Johnson & Johnson now also maintains direct control of manufacturing, although the workforce at the facility in southeast Baltimore remains with Emergent.
The existence of Mr de Notaristefani’s assessment was previously reported by Politico, but its details were not previously known. When asked about the report on Wednesday, White House spokeswoman Jen Psaki said she had to “check the details.”
Mr de Notaristefani’s concerns were confirmed by two former managers who spoke on condition of anonymity for fear of repercussions on their career. In interviews with The Times, they cited the oppressive workloads and shortcuts used to meet unrealistic schedules.
Mr. de Notaristefani noted that Emergent plans to increase the factory’s workforce to nearly 300. According to the company spokesman, there are currently 600 employees. Nevertheless, according to the ex-superiors, the employees are overwhelmed and some are often forced to work more than 70 hours a week.
A review of the months-long company logs received from The Times found that employees repeatedly reported deviating from manufacturing standards due to a lack of manpower and reduced production times.