Mr. Kramer received a $1.2 million cash bonus, the records show; the board found that he had “significantly exceeded expectations.” Three of the company’s executive vice presidents received bonuses ranging from $445,000 to $462,000 each.
Sean Kirk, the executive responsible for overseeing development and manufacturing operations at all of Emergent’s manufacturing sites, received a special bonus of $100,000 last year, over and above his regular bonus of $320,611, in recognition of his “exceptional performance in 2020,” and for significantly expanding the company’s contract manufacturing capability to address Covid-19, the documents show.
Mr. El-Hibri, who was praised for leveraging his connections, cashed in stock worth $42 million last year, according to an investigation by The Times.
Over the past two decades, Emergent has grown from a fledgling biotech company into a firm with annual revenues that last year topped $1.5 billion. Much of its success has come from selling products aimed at thwarting a bioterrorist attack, including its anthrax vaccine, to the Strategic National Stockpile, the nation’s emergency medical reserve.
The $628 million contract, awarded by the Trump administration nearly a year ago, was mostly to reserve space at Emergent’s Baltimore plant for vaccine manufacturing. The contract was approved by a former Trump administration official, Dr. Robert Kadlec, who previously consulted for Emergent.
The documents show that Emergent retained Dr. Kadlec to serve as a consultant from 2012 through 2015, agreeing to pay him $120,000 annually over that three-year period. In return, Dr. Kadlec agreed to provide advice on “international biosecurity and biodefense related issues to Emergent BioSolutions,” including outreach to senior government officials in Saudi Arabia and other countries.
Dr. Kadlec has said that while he did not negotiate the contract, he did sign off on it. The documents show he recommended that Emergent be given a “priority rating” so that it could be approved speedily.
Rebecca R. Ruiz contributed reporting.
WASHINGTON — Quality-control problems at a Baltimore plant manufacturing Covid-19 vaccines have led health officials on three continents to pause the distribution of millions of Johnson & Johnson doses, as the troubles of a politically connected U.S. contractor ripple across the world.
Doses made at the plant owned by Emergent BioSolutions have not been cleared by the Food and Drug Administration for use in the United States, and the Biden administration has repeatedly assured Americans that none of the Johnson & Johnson shots administered domestically were made there.
But millions of doses have been shipped abroad, including to Canada, the European Union and South Africa. Regulators in various countries are now working to ensure that those doses are safe after the disclosure in March that workers at the Baltimore plant accidentally contaminated a batch of Johnson & Johnson’s vaccine with the harmless virus used to manufacture AstraZeneca’s. Both vaccines were produced at the same site. The mistake forced Emergent to throw out up to 15 million Johnson & Johnson doses after tests showed that the batch failed to meet purity requirements.
E.U. officials, as well as those in Canada and South Africa, said there was no evidence that any of the doses they had received were tainted. But the problems identified in Baltimore have slowed their vaccination efforts while they perform additional quality assessments as a precaution.
said they would “not allow the release of any product until we feel confident that it meets our expectations for quality.” The plant is still finishing batches of vaccine that were already in process.
previously acknowledged that it had allowed doses of AstraZeneca’s Covid-19 vaccine made at the same Emergent plant to be sent to Canada and Mexico but said it had not attested to their quality, instead leaving that assessment to the company and authorities in both countries. Unlike the Johnson & Johnson vaccine, the AstraZeneca vaccine is not approved for use in the United States.
The Times reported last month that Emergent had discarded five lots of AstraZeneca vaccine — each the equivalent of two million to three million doses — between October and January because of contamination or suspected contamination at the same Bayview plant in Baltimore.
The European Union’s drug regulator, the European Medicines Agency, said in a statement to The Times that one batch of vaccine manufactured at the Emergent facility “is being used” after “a thorough testing of the batch and a review of the controls in place at the manufacturing site.” There is no indication of any problems with those doses.
That batch was distributed for use in the European Union only after meeting “the rigorous quality standards of our company and the European Medicines Agency,” Johnson & Johnson said in a statement.
Two more batches, amounting to about 2.5 million doses, are on hold as regulators in Europe and the United States investigate the cause of the contamination at the Emergent plant and ensure that problems have been fixed, the E.M.A. said.
“When the investigations conclude, E.M.A. may decide on actions to prevent future contamination of batches,” the statement said.
Batches of vaccine made at Emergent are not released for bottling until they have passed required safety tests, including one designed to identify “adventitious agents” such as a virus used in the manufacture of another product. People familiar with Emergent’s processes said the tests were much the same whether the vaccine was destined for domestic or foreign use.
one of the lowest vaccination rates of any country, and the Johnson & Johnson vaccine is particularly important to the nation’s plans. Many developing countries are relying on AstraZeneca’s vaccine, but South Africa stopped using it in February after a trial indicated that it was less effective against the dominant coronavirus variant then circulating in the country.
Under its contract with Johnson & Johnson, Emergent manufactured the active ingredient for the vaccine in bulk, and the substance was then sent to other facilities for final processing and packaging. One of the sites performing these final manufacturing stages is a plant run by the South African company Aspen Pharmacare. Johnson & Johnson announced in March that the site would support the company’s pledge to provide vaccine to countries throughout Africa.
The Canadian regulatory authority, Health Canada, said in a statement that officials were working with Johnson & Johnson and the F.D.A. to perform further assessments of vaccine manufactured at the Emergent facility and that the doses “will only be released for distribution once Health Canada is satisfied that they meet the Department’s high standards for quality, safety and efficacy.”
The newly disclosed delays underscore the global impact of the problems at the Baltimore factory operated by Emergent, a government contractor known for its aggressive lobbying and political connections.
As The Times previously reported, the federal government last year banked on Emergent to be the main domestic manufacturer for both the Johnson & Johnson and AstraZeneca vaccines even as evidence of serious quality problems mounted.
announced “significant revenue growth and corresponding profitability” for the first quarter of this year and projected record revenues for 2021, driven largely by the company’s Covid-19 vaccine manufacturing deals.
Emergent built a profitable business largely by cornering the market for biodefense products, a Times investigation found. Throughout most of the last decade, sales of the company’s anthrax vaccines accounted for nearly half of the annual budget of the nation’s emergency medical reserve, the Strategic National Stockpile, leaving the federal government with less money to buy supplies needed in a pandemic.
Emergent has repeatedly touted its influence in Washington in presentations to investors. Six of its 10 board members have previously served in government, and since 2010, the company has spent an average of $3 million a year on lobbying — far outspending similarly sized biotech firms, and roughly matching the outlays of some larger pharmaceutical companies.
Matina Stevis-Gridneff contributed reporting from Brussels and Ian Austen from Ottawa.
Canada’s drug and vaccine regulator said on Friday that it was withholding the country’s first shipment of the Johnson & Johnson vaccine to verify its safety and quality.
Health Canada, the regulator, said on Tuesday that none of the Johnson & Johnson vaccine, developed by the company’s Janssen subsidiary, had been made at an Emergent BioSolutions factory in Baltimore which had discarded millions of possibly contaminated doses of AstraZeneca’s coronavirus vaccine.
But in a statement issued on Friday evening, it said that since then it has “learned that a drug substance produced at the Emergent site was used in the manufacturing of the initial Janssen vaccines.”
The regulator said that it is now working with Janssen and the Food and Drug Administration in the United States to make sure that the vaccines meet Canada’s standards for “quality, safety and efficacy.”
were also produced at the Baltimore plant. Health Canada said last week that its review of that vaccine uncovered no problems or contamination.
Vaccine production at the plant has been suspended. Up to 15 million doses of the Johnson & Johnson vaccine made there were thrown away because contamination fears. Inspectors from the F.D.A. later found that Emergent did not fully investigate the contamination and found problems with the factory’s disinfection practices, it size and design, how it handled raw materials and trained its workers.
On Thursday, Emergent announced that it had removed some of its senior managers. Robert Kramer, the chief executive, acknowledged that the “loss of a batch for a viral contamination is extremely serious” but said that he hoped production would start again in Baltimore soon.
That was lifted a week ago after a warning label about the clotting issue was added.
The Baltimore plant is one of two federally designated sites that were supposed to be ready to manufacture vaccines or therapeutics in a public health emergency. In June 2020, the Trump administration awarded Emergent a $628 million contract, mostly to reserve space in Baltimore to produce coronavirus vaccines.
In Washington, Emergent is known for its aggressive lobbying and government connections spanning both Democratic and Republican administrations. The company’s board is stocked with former federal officials, and its ranks of lobbyists include former members of Congress.
“We’ve been at this for 22 years as a company,” Mr. Kramer said on Thursday’s call, adding that the firm’s relationships with government agencies, including the Biomedical Advanced Research and Development Agency, known as BARDA, which issued the $628 million contract, “remain intact and strong.”
In June 2020, shortly after the Trump administration awarded the contract to Emergent, a top official from Operation Warp Speed, the government’s fast-track vaccine initiative, warned that the company lacked enough trained staff and had a record of problems with quality control.
A copy of the official’s assessment, obtained by The Times, cited “key risks” in relying on Emergent to handle the production of vaccines developed by both Johnson & Johnson and AstraZeneca at the same plant in Baltimore.
Cross-contamination is a “well-known risk” when making two vaccines using live viruses, Mr. Kramer said on Thursday, but the decision to produce both in Baltimore was the government’s. There were layers of safeguards in place, he said, though Emergent believes that they “did not function as anticipated” and that the AstraZeneca virus probably contaminated the Johnson & Johnson batch.
“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 can get into a clinically viable vaccine, and which candidates would be most successful.”
Emergent BioSolutions, the company whose Baltimore manufacturing facility ruined up to 15 million doses of the Johnson & Johnson coronavirus vaccine, said Monday that it has temporarily shut down operations at the plant at the request of the Food and Drug Administration and acknowledged that the company must make improvements to “restore confidence” in its work.
The unusual acknowledgment came as regulators continue to inspect Emergent’s Bayview facility, as the Baltimore plant is known. The New York Times reported earlier this month that the F.D.A. was initiating a “for cause” audit of the Baltimore facility and that production of new batches of the Johnson & Johnson vaccine would be put on hold while the review was underway.
In Monday’s announcement, the company said that the F.D.A. inspection began a week ago and production stopped on Friday; the company also notified the Securities and Exchange Commission on Monday of the changes.
In a brief statement to reporters, Emergent also said it was quarantining existing vaccine substance produced at Bayview until after the inspection is over and it has had a chance to fix any problems that turn up in the review. The company’s stock has tumbled in recent weeks; it closed at $69.37 on Friday, down from $90.98 a month earlier.
It is unclear whether the vaccine was responsible for the clots.
Johnson & Johnson said in a statement on Monday that it is working with the F.D.A. and Emergent to address the findings of the inspection, and that it was “premature to speculate on any potential impact this could have on the timing of our vaccine deliveries.”
Emergent is a longtime government contractor that has spent much of the last two decades cornering a lucrative market in federal spending on biodefense. The Times reported last month that sales of its anthrax vaccines to the Strategic National Stockpile accounted for nearly half of the stockpile’s half-billion-dollar annual budget throughout most of the last decade, leaving the federal government with less money to buy supplies needed in a pandemic.
The company’s Bayview plant is one of two federally designated “Centers for Innovation in Advanced Development and Manufacturing” that were supposed to be at the ready in the event of a pandemic. The Times reported earlier this month that the Trump administration awarded a $628 million contract to the company, mostly to reserve space in the Baltimore facility, despite a history of problems.
accidentally mixed the ingredients of the two vaccines, ruining the doses and prompting the F.D.A. audit.
The Biden administration then stepped in and ordered Johnson & Johnson to take charge of manufacturing at the facility, and told Emergent to stop manufacturing the AstraZeneca vaccine to avoid future mix-ups.
“This inspection is ongoing,” the company said Monday. “While we await the F.D.A.’s full feedback, we are working with J.&J. and the F.D.A. on strengthening the supply chain for this vitally important vaccine.”
Because of the pandemic, most of the auditors drew their conclusions from documents and video tours, during which Emergent workers controlled the camera angles, one former company official said.
Johnson & Johnson’s auditors said monitoring reports for bacteria or other contaminants were filed four to six months late. AstraZeneca’s said that Emergent repeatedly loosened monitoring criteria so it appeared to meet them, resorting to measures like “historical averages.” But even then it failed the tests, the report said.
In another audit, BARDA officials documented similar concerns, classifying some of them, including the risks of microbiological contamination, as “critical.” That designation is reserved for the most serious problems that pose an immediate and significant risk.
Emergent’s own internal audit in July also said the flow of workers and materials through the plant was not adequately controlled “to prevent mix-ups or contamination.”
The reports echoed quality-control shortcomings documented in an April inspection by the F.D.A., reported earlier by The Associated Press, that concluded the facility was “not ready for commercial operations.”
Multiple audits underscore how poorly the company was prepared for the huge workload it accepted.
The Covid-19 projects required significantly more testing to ensure materials remained stable, but Emergent had just one employee coordinating it all, the BARDA audit found. Emergent acknowledged at the time that its testing system was “not ideal” and pledged to train at least one more Emergent worker and hire a third. BARDA did not respond to requests for comment on its audit or any of the others, beyond saying that it had “worked with Emergent to resolve the issues” raised during the F.D.A. inspection.
Another internal investigation in August found that Emergent approved four raw materials used to produce AstraZeneca’s vaccine without first fully testing them. That type of shortcut, called a conditional release of material, occurred on average twice a week in October, internal logs show. The measure was deemed necessary because the company was working with shortened production times, testing backlogs and the needs of Operation Warp Speed, the Trump administration’s crash vaccine development program. And while a manager “knowingly deviated” from standards, the report said, the batches of vaccine would be not released without quality and safety tests.