![]() ![]() ![]() Jim Clyburn (D-S.C.), chair of the coronavirus committee. “Doses were squandered despite repeated warnings from employees, outside consultants, pharmaceutical companies, and FDA regulators that the company’s manufacturing practices were unsafe,” said Rep. But the congressional investigation provides new details on the internal Emergent warnings about the problems the company could face scaling production for the Covid-19 shots. POLITICO was first to report about the early warnings from individuals working on the Trump administration’s Operation Warp Speed about Emergent’s problems. AstraZeneca did not immediately respond to requests for comment. ![]() “Since the start of the pandemic, Janssen has worked to produce a safe, high-quality COVID-19 vaccine,” the spokesperson said in a statement. He also disputed the report’s assertion that nearly 400 million doses had to be discarded because “It is very difficult to estimate dose equivalents for batches that do not complete the manufacturing process or leave the facility to be turned into vaccine.”Ī spokesperson for J&J said the company cooperated with the committee. Hartwig, in a statement released later Tuesday, said the company never knowingly misled the FDA, but would not specifically deny that the company hid potentially problematic batches from federal authorities. “Emergent has been open and forthcoming with the FDA, Congress and our partners about the work at our Bayview site and the challenges that were encountered including providing thousands of documents, willingly participating in a congressional hearing and inviting them to visit our facilities,” he said. “We have not allowed the distribution of any product without first conducting a thorough review of facility records and the results of quality testing performed by the manufacturer.”Įmergent remains committed to being a trusted partner of the federal government, said Matt Hartwig, a company spokesperson. “The identified concerns at the Emergent plant in April 2021” and “immediately took swift action,” a spokesperson told POLITICO. government and pharmaceutical contracts to produce the shots. The details of the investigation by the House Select Subcommittee on the Coronavirus Crisis and the Committee on Oversight and Reform, released Tuesday, which include troves of internal emails, underscore the degree to which Emergent staff and consultants working with the company knew of the extensive issues at Bayview before moving forward with U.S. ![]()
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