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.
EU 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.
Some doses from a single batch of the vaccine produced at Emergent are being administered in Europe, without problem, officials said. In addition, about 6 million to 9 million more doses are now on hold there and in the other countries because they came from batches that were produced in the same manufacturing suite and over the same two-day period in late February when the contamination occurred, according to health officials familiar with the situation.
The FDA has now called into question the equivalent of about 70 million doses from the plant, most of it intended for domestic use, and may decide that none of that vaccine can be released in the United States, those officials said.
One likely cause of the contamination is the failure of some employees to shower and change clothes as required when they moved between the factory zones dedicated to AstraZeneca and Johnson & Johnson, inspectors found. Safety tests identified traces of AstraZeneca’s virus in one batch of Johnson & Johnson’s vaccine before it ever left the factory, but the FDA is concerned that similar checks might have missed some lower-level contamination of the other batches that were produced simultaneously, according to a federal official who spoke on the condition of anonymity in order to describe internal discussions.
In a statement to The New York Times, an FDA spokesperson said the agency was “in close communication with our foreign regulatory counterparts regarding this ongoing matter to ensure they’re aware of the situation.”
There is now a discussion among regulators about balancing the need to save lives with the risk of using the questioned doses, even as it remains unclear what, if any, health consequences there would be.
Regulators in the United States have latitude to be cautious: The nation is awash in doses from two other federally authorized manufacturers, Pfizer-BioNTech and Moderna. The European Union has also secured ample supplies of Pfizer’s and Moderna’s shots and, like the United States, expects that about 70% of its adults will have received at least one dose of vaccine by July.
But the situation is different in countries like South Africa where the percentage of vaccinated residents is much lower and vaccine supplies are significantly tighter. In Canada, most provinces have opted to delay second doses of Pfizer, Moderna and AstraZeneca for four months, except for unusually vulnerable people, to maximize the number who are at least partly protected.
After FDA inspectors documented serious quality problems at Emergent’s Bayview facility in Baltimore last month, the Maryland-based company paused new production there, and top officials at the agency 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.
Neither the FDA nor its parent agency, the Department of Health and Human Services, would say what role, if any, the federal government played in the shipment of Johnson & Johnson doses abroad or when and where they were shipped. White House officials did not respond to repeated requests for comment.
In its statement to the Times, the FDA spokesperson said, “In general, individual importing countries determine if a product meets that country’s standards for importation.”
Emergent referred questions to Johnson & Johnson and the FDA. “They control where the product goes after we manufacture it,” Matt Hartwig, a spokesperson for the company, said in an email. In a statement, Johnson & Johnson said it was working with U.S. and other regulators and emphasized that “quality and safety” were paramount.
The Biden administration 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 2 million to 3 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 EMA said.
“When the investigations conclude, EMA 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.
The EU regulator gave no timetable for its review and said “no other batches” coming from the Emergent facility would be released “until investigations are concluded.”
In South Africa, doses are sitting in a facility awaiting “a protracted safety verification process with international regulatory agencies,” the nation’s health minister said in a statement. “This is a precautionary measure following the adverse findings” at the Emergent plant, said the minister, who also expressed hope that the held-up doses could be cleared “by the middle of May.”
South Africa has 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 that was 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 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 FDA 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.
Although the government awarded Emergent a $163 million contract in 2012 to ready the Baltimore plant to make vaccines in response to a pandemic, the company had not met a key requirement for demonstrating large-scale manufacturing ability as a June 2020 deadline neared. That month, however, federal officials nonetheless announced a new $628 million deal, most of it to reserve manufacturing capacity at the Baltimore plant for COVID-19 vaccine.
The company’s stock price soared, and its chief executive, Robert Kramer, boasted during a virtual conference for investors in March that profitability in 2020 had been “off-the-chart successful.” In a conference call with Wall Street analysts last week, Emergent’s chief financial officer 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 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.