The Biden administration said it did not know of manufacturing problems at the Emergent factory when it approved shipping millions of doses of AstraZeneca’s vaccine. The company says the doses were safe.
WASHINGTON — The Biden administration said Friday that it did not know that a Baltimore factory had discarded millions of possibly contaminated doses of AstraZeneca’s coronavirus vaccine when President Biden last month released the company to ship vaccines manufactured there to Mexico and Canada.
Canadian and Mexican officials said on Friday that they had assurances from AstraZeneca that the millions of doses they received were safe. Some of the doses have been distributed to the public in both countries, the officials said.
Biden administration officials said they had not vouched for the quality of the AstraZeneca vaccine doses made at the Baltimore plant, leaving the decision on whether to use them to the company and the Canadians and Mexicans themselves.
The administration, however, did inform the two countries of another episode of possible contamination, involving a similar vaccine developed by Johnson & Johnson, that occurred more recently at the same Baltimore plant.
Vaccine production at the plant, operated by Emergent BioSolutions, has been halted. Up to 15 million doses of the Johnson & Johnson vaccine needed to be discarded because of the contamination fears. This week, inspectors from the Food and Drug Administration said Emergent had failed to fully investigate the episode, and they also found fault with the plant’s disinfection practices, size and design, handling of raw materials and training of workers.
The F.D.A. has informed regulators in other countries about its findings, according to an F.D.A. spokesman who also said the agency was “providing additional information as requested” and would “continue to work closely with its international partners.”
The spokesman said that products not authorized for use in this country, like the AstraZeneca vaccine, “may nonetheless be exported if certain conditions are met,” but would not specify what those were.
Other administration officials, noting that AstraZeneca had not applied for emergency authorization of its vaccine in the United States, said it was up to the company and regulators in Canada and Mexico to determine whether the exports and the manufacturing facility were safe.
As news of the Emergent plant’s troubles rippled across Canada and Mexico, leaders of both countries sought to reassure their citizens about the vaccines manufactured by the company. Shortly before he headed to a drugstore on Friday to receive a shot of the AstraZeneca vaccine, Prime Minister Justin Trudeau of Canada said he was confident that supplies sent by the United States were safe.
“We have confirmed that the doses received from the United States a number of weeks ago are not, have not been subjected to the challenges that have come up currently in the Baltimore plant,” Mr. Trudeau said at a news conference. “There is absolutely no danger of that for Canadians.”
In Mexico, a senior government official said AstraZeneca had provided documentation indicating that the doses had passed quality tests and were not affected by issues at the Emergent factory. “We are sure that the product that was applied to Mexican people was a safe, quality product,” Mexico’s coronavirus czar, Hugo López-Gatell, said at a briefing on Friday night.
The Biden administration’s acknowledgment that it had been unaware of the discarding of the lots of AstraZeneca’s vaccine, which The New York Times reported occurred between October and January, underscores concerns about the government’s oversight of a key contractor in the federal response to the pandemic. U.S. officials bet on Emergent to manufacture both the Johnson & Johnson and AstraZeneca Covid-19 vaccines even as a series of audits identified serious quality shortcomings at the plant.
The F.D.A. has still not cleared the Emergent plant to release doses of either vaccine in the United States and has not indicated when, or whether, it will do so. While AstraZeneca’s vaccine is not authorized for use in the United States, tens of millions of doses of it have been sitting idly at manufacturing plants.
The White House said last month that the federal government, which committed last year to buying 300 million doses from AstraZeneca, intended to “loan” 2.5 million doses to Mexico and 1.5 million doses to Canada. U.S. officials say the two countries were eager for the doses and have since expressed interest in getting more, especially because of a recent drop in supplies from India, another major supplier of vaccine.
Canadian officials, however, said on Friday that the nation’s own regulators were reviewing the recent F.D.A. report on its inspection of the Baltimore facility, which “will inform whether additional measures are required to ensure the safety of future supply.”
Emergent is a longtime government contractor that has virtually cornered 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 government awarded the company a $163 million contract in 2012 to ready the Baltimore facility to mass-produce vaccines in response to a pandemic. Last June, the Trump administration awarded the company a $628 million contract, mostly to reserve space at the Baltimore plant.
But The Times earlier this month documented a string of problems at the plant, many of which were known to federal officials.
Shortly after the contract was awarded to Emergent last June, a top federal pandemic official warned that the Baltimore plant lacked enough trained staff members and had a record of problems with quality control. A copy of the official’s assessment cited “key risks” in relying on Emergent to handle the production of the vaccines.
The Times also reported that Emergent had discarded AstraZeneca’s vaccine — five lots in all, each the equivalent of two million to three million doses — because of contamination or suspected contamination, according to internal logs, a government official and a former company supervisor.
A senior federal health official, speaking on condition of anonymity because of the sensitive nature of the matter, said Friday that the White House and senior leaders at the Department of Health and Human Services learned of the discarded AstraZeneca lots only after the Times report.
Last month, The Times reported that workers at the Emergent plant in Baltimore had conflated ingredients of the two vaccines, ruining up to 15 million doses of the Johnson & Johnson vaccine. Federal officials ordered major changes to the plant after those revelations.
The Biden administration ordered Emergent to stop making the AstraZeneca vaccine, and put Johnson & Johnson in charge of running the facility.
In a statement late Thursday, AstraZeneca said that the doses delivered to Mexico and Canada “met the stringent requirements we are required to follow,” and that “required safety tests and quality control measures” were conducted at each step of the production process and before the batches were released.
In the statement, which was reported earlier by CBS News, AstraZeneca said, “The quality information from the manufacturing plants involved was properly submitted to the relevant regulatory agencies in each country to support authorization and approval of shipments from this supply chain.”
Ian Austen, Natalie Kitroeff and Oscar Lopez contributed reporting.
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