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illness 2nd COVID-19 vaccine trial paused over unexplained illness October 13, 2020 The company declined to reveal any more details about the illness, citing the participant's privacy. paused U.S. recommends 'pause' for Johnson & Johnson vaccine in response to 6 clot reports The Associated Press · Posted: Apr 13, 2021 The clots occurred in veins that drain blood from the brain and occurred together with low platelets. All six cases were in women between the ages of 18 and 48. Speaking to reporters on a teleconference, Dr. Peter Marks, the director of the FDA Center for Biologics, said the reports appear similar to a rare, unusual type of clotting disorder that European authorities say is possibly linked to another COVID-19 vaccine not yet cleared in the U.S., from AstraZeneca. Both the J&J and AstraZeneca products are viral vector load vaccines. There have been no reports of any post-vaccination clots in people who have received the Pfizer or Moderna shots, which are based on mRNA technology, Marks said.

qc Newly arrived doses processed in U.S. plant mired in quality-control problems Health Canada holding off on Johnson & Johnson COVID-19 vaccine distribution Health Canada is holding off on distributing the first shipment of Johnson & Johnson's COVID-19 vaccine after it became clear the doses that arrived on Wednesday were processed in the same U.S. plant that's been mired in quality-control problems. Reports first surfaced in the New York Times earlier this month about problems at a Baltimore, Md., plant run by Emergent BioSolutions, where both the AstraZeneca-Oxford and Johnson & Johnson vaccines were being manufactured. Emergent announced earlier this month that 15 million doses of the latter had been ruined by cross-contamination — a development that prompted the White House to put Johnson & Johnson in charge of the facility. troubled Up to 15 million doses of the Johnson & Johnson vaccine needed to be discarded because of the contamination fears. 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.