Chris Hamby, Sharon LaFraniere and Sheryl Gay Stolberg
WASHINGTON — More than eight years ago, the federal government invested in an insurance policy against vaccine shortages during a pandemic. It paid Emergent BioSolutions, a Maryland biotech firm known for producing anthrax vaccines, to have a factory in Baltimore always at the ready.
When the coronavirus pandemic arrived, the fac- tory became the main U.S. location for manufacturing COVID-19 vaccines develmammoth manufacturing oped by Johnson & Johnson task, despite Emergent’s havand AstraZeneca, churning ing received a $163 million out about 150 million doses federal contract to improve as of last week. the facility and prepare it for
But so far not a single dose high-volume production. has been usable because regThe loss of the Johnson ulators have not yet certified & Johnson doses was not the factory to allow the vacthe first time the company cines to be distributed to the threw out coronavirus vacpublic. Last week, Emergent cine for fear of contamina- said it would destroy up to tion. Between early Octo- 15 million doses’ worth of ber and January, Emergent the Johnson & Johnson vacdiscarded five lots of Astracine after contamination Zeneca vaccine — each the with the AstraZeneca vacequivalent of 2 million to 3 cine was discovered. million doses — because of
Emergentand government contamination or suspected health officials have long contamination, according to touted their partnership as a internal logs, a government success, but an examination official and a former com- by The New York Times of pany supervisor. manufacturing practices at Audits and investigations the Baltimore facility found — including ones conducted serious problems, including in 2020 by Johnson & Johna corporate culture that often son, AstraZeneca, two fedignored or deflected missteps eral agencies and Emergent’s and a government sponsor, own quality evaluators — the Biomedical Advanced found that Emergent had not Research and Development followed some basic indusAuthority, that acted more try standards at the Baltias partner than police. more plant, and identified
Previously undisclosed repeated shortcomings. internal documents and While audits always find interviews with current and problems, federal officials former federal officials and and outside experts said that former company employees the pattern of lapses sugdepict a factory operation illgested deeper quality issues. equipped to take on such a “These are the fundamental steps,” said Dr. Ajaz Hussain, a pharmaceutical quality expert who oversaw efforts by the Food and Drug Administration to ensure quality in drug development and manufacturing from 2000 to 2005. “If you are making mistakes or errors in the fundamentals, what else is wrong with your system? That would be my question.”
An audit conducted for AstraZeneca specifically highlighted the risks of viral cross-contamination, which experts believe was responsible for tainting the millions of Johnson & Johnson doses, according to a review of the confidential document by The Times. The audits and investigations also flagged a persistent problem with mold in areas required to be kept clean, poor disinfection of equipment, the repeated approval of raw materials that had not been fully tested, and inadequate training.
Because other manufacturers are now churning out so many COVID-19 vaccine doses, it does not appear that the disruptions in Baltimore will upend the Biden administration’s expedited timetable for vaccine supplies and availability.