![]() ![]() 27 because the Emergent plant has not received a green light from the agency. The rollout of the vaccine has been slow since the FDA awarded Johnson & Johnson an emergency use authorization on Feb. Three FDA officials, two investigators and a senior adviser signed off on the inspection. The 13-page report described nine separate problems, including a “failure to conduct thorough investigations into unexplained discrepancies,” facilities “not maintained in a clean and sanitary condition” and employees not being properly trained. An administration official noted that the nation's vaccination goals could be achieved without further Johnson & Johnson vaccine deliveries.Įmergent, a company with connections to former government officials, received at least $1.1 billion combined from the federal government and Johnson & Johnson last year to produce drug substance, the active ingredient in the vaccine. is approaching 200 million vaccinations, a milestone President Joe Biden highlighted in a speech Wednesday. this summer, a blow to vaccinating hard-to-reach populations that may face obstacles in getting a second shot as two other authorized vaccines require. The issues are not related to separate concerns that the Johnson & Johnson vaccine could be associated with exceedingly rare but potentially dangerous blood clots, the FDA clarified.īut the debacle raises serious questions about whether Johnson & Johnson can maintain its commitment to deliver 100 million of its one-shot doses to the U.S. No doses of the vaccine that have already been distributed and administered in the United States were contaminated, as they were sourced from the company’s plant in the Netherlands. "There is no assurance that other batches have not been subject to cross-contamination," reads the inspection document, known as an FDA Form 483. The inspection was triggered by an accident that ruined 15 million doses by cross-contaminating them with ingredients in the AstraZeneca vaccine.įDA inspectors found that plant operators did not do a thorough investigation into that incident, and that the integrity of other batches may also be compromised. company producing a crucial component of the Johnson & Johnson vaccine, and completed the inspection Tuesday. The agency launched an inspection on April 12 of the Baltimore plant of Emergent BioSolutions, the U.S. A contractor for Johnson & Johnson may have spoiled more COVID-19 vaccine doses than previously understood, according to a scathing Food and Drug Administration inspection report released Wednesday. ![]()
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