Wednesday’s vaccine ingredient mix-up could see the FDA’s review of the manufacturing facility delayed, potentially disrupting Johnson & Johnson’s plan to deliver 100 million single-shot vaccines to the US by the end of May.ĭespite the setback, the company said additional manufacturing supervision and support at the Emergent plant will ensure the delivery of an additional 24 million vaccine doses to the US by the end of April. Therefore, as we continue to work with FDA and Emergent toward the Emergency Use Authorisation of the Emergent Bayview Facility, Johnson & Johnson is providing additional experts in manufacturing, technical operations and quality to be on-site at Emergent to supervise, direct and support all manufacturing of the Johnson & Johnson Covid-19 vaccine.”Īny Johnson & Johnson jabs produced by Emergent BioSolutions are not permitted to be used until the contract manufacturer’s bulk vaccine substance receives FDA approval. “Quality and safety continue to be our top priority. This batch was never advanced to the filling and finishing stages of our manufacturing process. Johnson & Johnson said in a statement: “ quality control process identified one batch of drug substance that did not meet quality standards at Emergent BioSolutions, a site not yet authorised to manufacture drug substance for our Covid-19 vaccine. The mix-up did not affect J&J doses already being delivered and used across the US, the Times reported, but would lead to delays for millions of vaccine doses due to come from the Bayview plant in the coming months.
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