Catalent is now on track to deliver over a billion doses of COVID-19 vaccines and treatments in 2021. “The site recently completed a major expansion and scale-up activities on a dedicated, high-speed vial-filling line to support the production of this important vaccine. It is not clear exactly how many doses Catalent has shipped, and the company did not comment on the number.īut over time, the FDA authorization will let Catalent “produce and ship millions of doses,” said Mike Riley, the company’s regional biologics president for North America. “They are slow to address some of this stuff. The viral vector vaccine developed by J&Js subsidiary, Janssen Pharmaceuticals, was authorized by Health Canada as safe and effective last week. “There is a slowness to J&J getting stuff done,” a person familiar with the process said Monday. J&J did not include its manufacturing partners in its original emergency use application, so doses made by the partners have been sitting unused while tensions have ratcheted up between the federal government and the drugmaker over manufacturing delays. Subscribe on Apple Podcasts | Subscribe on Google PodcastsįDA does publicly post vaccine authorizations, including the clearance for Johnson & Johnson, on its website. It has caused confusion before, such as when Hurricane Maria hit Puerto Rico in 2017 and FDA could confirm that pharmaceutical companies would experience production delays, but could not disclose which ones they were. A few Catholic leaders across the country have urged parishioners not to take the Johnson & Johnson shot they call morally compromised, because the vaccine was produced with cell lines. The agency is regularly barred from publicly discussing drugmakers’ manufacturing plants. “The manufacture of authorized COVID-19 vaccines is limited to those facilities identified and requested for authorization by the sponsor,” FDA said in a statement. Nearly 30 million doses of the Pfizer-BioNTech vaccine are sitting unused, as. Despite logistical challenges and regulatory delays that have hindered getting Emergent and Catalent-supplied doses to the public, J&J has insisted that it will hit its 20-million-dose goal this month.Īdding to the confusion, FDA refused to confirm that it had authorized Catalent to produce J&J vaccine, saying that information about which contract manufacturers a pharmaceutical company enlists is considered “confidential commercial information” that it is legally prohibited from disclosing. Johnson & Johnson’s decline in the United States has dovetailed with decreasing demand for Covid vaccines overall. health officials are increasingly worried that J&J will not be able to meet its March delivery goal. Much of that supply is coming from another contract manufacturer, Catalent Inc., which last week was authorized to make the shot at a facility in Bloomington, Indiana.The delayed Emergent authorization comes as U.S. government more than 20 million doses, and that it expects to deliver another 24 million by the end of April. New Brunswick, New Jersey-based J&J said it beat its March delivery target, providing the U.S. Representatives for Emergent declined to comment, deferring to J&J’s statement. The Biden administration has touted J&J’s one-dose, refrigerator-stored Covid shot as an efficient way to confer protection to Americans, particularly those in hard-to-reach places. Those vaccines require a two-dose regimen. and Moderna Inc., met their first quarter targets of 120 million doses and 100 million doses, respectively. The two other vaccine producers, Pfizer Inc. J&J, as of now, has produced by far the smallest supply of the U.S.-authorized Covid-19 vaccines. “This batch was never advanced to the filling and finishing stages of our manufacturing process.” “This quality control process identified one batch of drug substance that did not meet quality standards at Emergent BioSolutions, a site not yet authorized to manufacture drug substance for our Covid-19 vaccine,” J&J spokesman Jake Sargent said in an emailed statement. Johnson & Johnson and President Biden’s team have said that the company met its obligations to produce 20 million doses of its vaccine by the end of March. In a statement, J&J said a batch of drug substance failed its quality test. Subscribe to The Capsule, a weekly brief monitoring advances in health care and biopharma, delivered free to your inbox. There’s no safety fears with doses shipped, which came from other, authorized plants. have come from that plant, which isn’t authorized yet, two administration officials said, speaking on condition of anonymity. None of the doses produced and shipped so far in the U.S. will have enough vaccine for all adults in May, the people said. facility in Baltimore, isn’t expected to change President Joe Biden’s expectation that the U.S. The issue, which occurred recently at an Emergent BioSolutions Inc.
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