Johnson & Johnson, one of a wave of companies racing to produce a vaccine for the novel coronavirus, aims to sign up a network of manufacturing partners to help boost capacity ahead of a potential FDA approval. Now, in its second sweeping production deal, J&J has paired up with Catalent to set the stage for the shot’s debut.
J&J signed an agreement Wednesday to ramp up capacity at Catalent’s 875,000-square-foot Bloomington, Indiana facility, the partners said Wednesday.
Catalent will hire an additional 300 workers at the plant starting in July with the goal of reaching 24/7 manufacturing schedules by January.
Leveraging its “deep expertise” in sterile formulation at the Bloomington facility, Catalent brings experience in drug substance development and manufacturing, and drug product fill/finish to the deal, the company said. Catalent will also lean on its network of sterile drug facilities in Brussels and Anagni, Italy.
The Catalent deal is J&J’s second agreement in as many weeks to scale up manufacturing capacity for its COVID-19 shot candidate in anticipation of a future approval.
Last week, J&J inked a deal with Emergent BioSolutions to ramp up production of the shot, which the drugmaker hopes to take into human trials in September..
As part of its Emergent deal, J&J will expand its own capacity for producing the vaccine candidate, and Emergent will begin using its “molecule-to-market” manufacturing to chip in later this year. Emergent will also reserve capacity to support a potential commercial rollout of J&J’s shot beginning as early as 2021 should it nab an approval.
J&J has already earmarked its own Leiden, Netherlands, facility for clinical vaccine production and plans to begin producing the vaccine “at-risk” to support human trials.
J&J called the Emergent deal the “first in a series” to help boost its global scale ahead of the hoped-for approvals.
Despite J&J’s hopes that its vaccine could be ready to ship as early as next year, some market watchers think that timeline is too optimistic.
In a 25-page note earlier this week titled “Sober Up! 25 Reasons Not to Count on COVID Vaccine for Herd Immunity in 1-2 years,” SVB Leerink analyst Geoffrey Porges says it’ll take several years—not months—to develop a safe and effective vaccine and administer it to enough people for widespread protection.
“We view the current expectations for a vaccine in this timeframe as the equivalent of standing 24 feet (the usual distance is 8 feet) from a dartboard, with one dart in hand, and counting on a bullseye from one throw,” the analyst wrote. “It is theoretically possible, but highly unlikely, that such expectations are correct.”
J&J and its fellow vaccine-making hopefuls are hoping to prove the analysts wrong, counting on new technologies, quick scale-ups and cooperation from regulators to make the difference.