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. Updated on: Ap/ 7:04 PM / CBS/AP Johnson & Johnson said Wednesday that a batch of COVID-19 vaccine made by a subcontractor can't be used because it didn't meet quality control. “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. The companys Chief Global Supply Chain Officer shares the measures the company has taken to maintain its supply chain operations during the current novel coronavirus outbreak. The agency is regularly barred from publicly discussing drugmakers’ manufacturing plants. What You Need to Know About How Johnson & Johnsons Supply Chain Is Responding to the COVID-19 Pandemic. “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. Given that figure, the reactions in Colorado and North. ![]() 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. Overall, about 2 of Johnson & Johnson vaccine recipients report severe side effects, most commonly fatigue, muscle pain and fever. health officials are increasingly worried that J&J will not be able to meet its March delivery goal. ![]() The delayed Emergent authorization comes as U.S.
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