Moderna aims for light-speed COVID-19 shot rollout with Catalent fill-finish deal

With the search for a COVID-19 vaccine in hyperdrive, drugmakers have signed a wave of massive manufacturing tie-ups to help secure capacity for a possible winner. Now, Moderna has tapped CDMO Catalent to help out on the finishing stages of its shot with the goal of churning out millions of doses within months.

Catalent will handle fill-finish duties for up to 100 million doses of Moderna's mRNA COVID-19 vaccine hopeful at the CDMO's Bloomington, Indiana, site, the partners said Thursday.

Catalent will put its team into 24-7 production mode to start churning out Moderna's vaccine as soon as the third quarter, filling vaccine vials and packaging them up for distribution in the U.S. The partners are in talks for capacity beyond the initial 100 million-dose order, the companies said.

“Catalent’s proven expertise in manufacturing scale-up and commercial production are well suited to support Moderna’s efforts to prepare for wide-scale supply of this vaccine candidate so that it is available if appropriate to address the pandemic," Catalent CEO John Chiminski said in a release.

Catalent's latest tie-up comes less than two weeks after the New Jersey-based CDMO inked a similar deal with British drugmaker AstraZeneca to chip in on fill-finish capacity for the University of Oxford's adenovirus-based COVID-19 shot, AZD1222.

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Earlier this month, Catalent agreed to produce "hundreds of millions of doses" of AstraZeneca's hopeful at its 305,000-square-foot manufacturing facility in Anagni, Italy.

Catalent is scheduled to begin producing those doses in August 2020 and to potentially continue through March 2022 if the vaccine receives full regulatory approval. Catalent would not disclose financial terms of the deal, a spokesman said.

Meanwhile, Moderna has been equally aggressive in looking to shore up production capacity for its COVID-19 shot, one of a group of front-runners highlighted by the Trump administration's Operation Warp Speed for early approval and widespread distribution this year.

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Back in May, Moderna offered up $1.34 billion in stock as part of a cash-raise effort to finance its expansive manufacturing and distribution plans to reach 1 billion doses per year of its mRNA candidate.

That same day, Moderna offered an early peek into results from a phase 1 test in eight individuals, jacking up its stock price by 20%. Earlier this month, Moderna said it was finalizing protocol for phase 3 human trials and plans to start testing in July.

Also part of Moderna's aggressive expansion plans is a deal with Lonza, inked in early May, to flesh out manufacturing suites at two of the CMO's facilities to boost production. The agreement will initially bring suites online at Lonza facilities in the U.S. and Switzerland, with technology transfer scheduled to begin this month.

With the manufacturing apparatus in place, Moderna hopes to begin batch production at the U.S. site as early as July.

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Getting the supply chain running at light speed will go a long way toward reaching the Trump administration's goal of regulatory approval for at least one vaccine by the end of 2020.

Earlier this week, Jefferies healthcare strategist Jared Holz told MarketWatch that “perhaps multiple vaccines” could win FDA authorization “early in the fourth quarter and quell fears of a second wave of COVID-19.”

The team cited several reasons an approval, or emergency use authorization, may come before the November election. For one, President Donald Trump could push the FDA behind the scenes to issue an approval or emergency authorization.

Moderna and AstraZeneca, both vaccine front-runners, have already told the analysts an approval could happen on that timeline, according to the report.