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The New York Times

Vaccines made at the troubled Baltimore factory have been shipped to Canada and Mexico

WASHINGTON – The Biden government announced Friday that it was unaware that a Baltimore factory had discarded millions of potentially contaminated doses of AstraZeneca's coronavirus vaccine when President Joe Biden used the company to ship vaccines made there last month released to Mexico and Canada. Canadian and Mexican officials said Friday they had received assurances from AstraZeneca that the millions of doses they had received were safe. Some of the cans were distributed to the public in both countries, officials said. Biden administration officials said they had not vouched for the quality of the AstraZeneca vaccine doses made at the Baltimore facility, leaving it up to the company and the Canadians and Mexicans themselves to decide whether to use them. Sign up for The Morning Newsletter of the New York Times. However, the government informed the two countries of another episode of possible contamination, which is a similar vaccine developed by Johnson & Johnson that has more recently appeared at the same Baltimore plant. Vaccine production at the facility operated by Emergent BioSolutions has ceased. Up to 15 million doses of the Johnson & Johnson vaccine had to be discarded because of fears of contamination. This week, Food and Drug Administration inspectors said Emergent had not fully investigated the episode and they had also found errors in disinfection practices, the size and design of the facility, the handling of raw materials, and the training of workers. The FDA has notified regulators in other countries of its findings, according to an FDA spokesman who also said the agency will provide "additional information upon request" and will "continue to work closely with its international partners." The spokesman said that products not approved for use in the country, like the AstraZeneca vaccine, "can still be exported if certain conditions are met" but would not specify what they were. Other administrative officials noted that AstraZeneca had not applied for an emergency permit for its vaccine in the US, and said it was up to the company and regulators in Canada and Mexico to determine whether its exports and manufacturing facility were safe. When the news broke of the problems at the Emergent plant in Canada and Mexico, the leaders of both countries tried to reassure their citizens about the vaccines the company made. Just before going to a drugstore on Friday to get a shot of the AstraZeneca vaccine, Canadian Prime Minister Justin Trudeau said he was confident the U.S. shipments were safe. "We have confirmed that the cans received from the US a few weeks ago did not face the challenges currently encountered at the Baltimore plant," Trudeau said at a press conference. "There is absolutely no danger for Canadians." In Mexico, a senior government official said AstraZeneca had provided documentation showing that the cans passed quality checks and were not affected by issues at the emergent factory. "We are sure that the product that was used by Mexicans was a safe quality product," said Mexican coronavirus tsar Hugo López-Gatell at a briefing on Friday evening. Confirmation by the Biden government that it was unaware that AstraZeneca's vaccines, reported by the New York Times between October and January, had been ditched underscores concerns about government oversight of a key contractor in the response Federal on the pandemic. U.S. officials are relying on Emergent to manufacture both Johnson & Johnson's and AstraZeneca's COVID-19 vaccines, even when a series of audits found serious quality deficiencies at the facility. The FDA has not yet cleared the emergent facility for the release of vaccine doses in the US and has not indicated when or if it will. While AstraZeneca's vaccine isn't approved for use in the U.S., tens of millions of doses of it have been sitting idle in manufacturing facilities. The White House said last month that the federal government, which committed to buying 300 million cans from AstraZeneca last year, intends to "borrow" 2.5 million cans to Mexico and 1.5 million cans to Canada. US officials say the two countries were excited about the doses and have since expressed interest in more, particularly due to the recent drop in shipments from India, another major vaccine supplier. However, Canadian officials said Friday that national regulators were reviewing the latest FDA report on the inspection of the Baltimore facility, which "will provide information about whether additional measures are needed to ensure the safety of future supplies." Emergent is a longtime government contractor who has practically cornered a lucrative market for federal biological defense spending. The Times reported last month that the sale of its anthrax vaccines to the Strategic National Stockpile was nearly half of the annual half-billion dollar stockpile budget for most of the last decade, leaving the federal government with less money to raise in a year needed to buy supplies pandemic. The government awarded the company a $ 163 million contract in 2012 to prepare the Baltimore facility for mass production of vaccines in response to a pandemic. In June, the Trump administration placed the company on a $ 628 million contract, primarily to reserve space at the Baltimore plant. However, earlier this month The Times documented a number of problems at the plant that many federal officials were aware of. Shortly after the contract was awarded to Emergent in June, a senior federal pandemic official warned that the Baltimore plant did not have enough trained staff and that quality control issues had arisen. A copy of the official's assessment identified "major risks" of relying on Emergent to manufacture the vaccines. The Times also reported that Emergent had discarded AstraZeneca's vaccine – five batches total, each representing 2 to 3 million doses – due to contamination or suspected contamination, according to internal logs, a government official and a former company manager. A senior federal health official, who spoke on condition of anonymity due to the sensitivity of the matter, said Friday that the White House and senior officials from the Department of Health and Human Services did not find out about the discarded AstraZeneca lots until after the Times report would have. Last month, the Times reported that workers at the Emergent Baltimore plant had merged the ingredients in the two vaccines and ruined up to 15 million doses of the Johnson & Johnson vaccine. Federal officials ordered major changes to the facility following these revelations. The Biden administration ordered Emergent to cease manufacturing the AstraZeneca vaccine and hired Johnson & Johnson to lead the facility. In a statement late Thursday, AstraZeneca said the cans shipped to Mexico and Canada "meet the stringent requirements we must adhere to" and that "necessary safety tests and quality control measures" have been carried out at every step of the production process and prior to the batches being released. In the statement previously reported by CBS News, AstraZeneca said, "The quality information from the manufacturing facilities involved has been duly submitted to the relevant regulatory authorities in each country to aid in the approval and approval of shipments from this supply chain." the New York Times. © 2021 The New York Times Company

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