Talks are ongoing with troubled CDMO Emergent, but a robust production network means J&J is still on track to produce a billion doses of its COVID vaccine this year.
In February, Johnson & Johnson (J&J) became the third firm to receive Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a COVID-19 vaccine. The single shot offering received European authorization the following month.
However, the vaccine has hit several snags. Questions around potential blood clots saw both the US and Europe temporarily halt rollout, but on the production side contamination issues at contract development and manufacturing organization (CDMO) Emergent BioSolutions created another thorn in J&J’s side.
Image: iStock/Sundry Photography
Emergent’s Bayview, Maryland facility had been contracted by both J&J and AstraZeneca to make their respective COVID vaccines, but an ingredient mix up rendered 15 million doses unusable and landed the plant with an FDA Form 483 and a directive to stop production in April.
Two months on and J&J remains confident in its supply of its COVID vaccine and that it can iron out the issues at Emergent.
“The Emergent situation is an ever evolving kind of situation, but we are working extremely closely with health authorities, FDA and close collaboration to get that facility in a state that we’re proud of and create lots of vaccine for the world,” Mathai Mammen, J&J’s global head of R&D said at the Goldman Sachs 42nd Annual Global Healthcare Conference this week.
He added the firm is “not only dependent” on Emergent for supply. “We have a number of other facilities in the world that are making both vaccine and drug substance, and so vials drug product, and these will come online very shortly, and we remain really confident that that pacing of a billion doses by year end should be there.”
Beyond Emergent, the firm has inked numerous partnerships over the past year for both drug substance and fill & finish capacity to support the vaccine. Examples include contracts with Big Pharma rivals Merck & Co., and Sanofi, and CDMOs Vibalogics, Catalent, IDT Biologika, and Grand River Aseptic Manufacturing (GRAM).
Meanwhile, the firm is also harnessing its internal manufacturing network, including its Leiden, The Netherlands site.
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