Early in the COVID-19 pandemic, Emergent BioSolutions positioned itself as a manufacturer to beat in the vaccine race. Now, as its partner Johnson & Johnson gears up for a potential U.S. rollout, Emergent is working overtime to get those doses ready.
The Maryland-based contract manufacturer inked a five-year work order with Johnson & Johnson in July, pledging to kick off “large-scale” drug substance manufacturing beginning in 2021. The work has now commenced—not just for J&J’s shot, but AstraZeneca’s rival adenovirus-based vaccine, too.
The quick ramp-up wasn't easy, but the company has now settled into a “manufacturing cadence,” Sean Kirk, EVP of manufacturing and technical operations, said in an interview.
Alongside equipment and material ramps up, the company hired 800 new employees in 2020 to carry its manufacturing work forward, Kirk said. About 40% of those staffers are spread across Emergent's three Maryland facilities tapped in the government initiative formerly known as Operation Warp Speed.
While the company is keeping specific production targets under wraps, Kirk added he is “confident that we can meet our commitments with our partners.”
Emergent is chipping in on up to 300 million doses Johnson & Johnson pledged to the U.S. in August, and the 300 million doses AstraZeneca agreed to sell in May. The pandemic landscape has changed considerably since officials struck those deals, with J&J’s vaccine supplanting AstraZeneca’s as the next likely contender for a U.S. emergency nod. Meanwhile, AstraZeneca was expected to start delivering doses to the U.S. as early as October 2020—a goal that clearly didn't pan out.
Still, J&J has a big role to play with its vaccine, analysts say, and not just in the U.S. In a note to clients, Cantor Fitzgerald wrote that the single-dose shot "has perfect characteristics to potentially make the product the most desirable vaccine in countries which have a less sophisticated supply chain than the U.S."
J&J is currently on deck to provide 100 million doses of its shot by the first half of the year, and Emergent is "right on schedule to support that," CEO Bob Kramer said on a call with analysts Friday.
AstraZeneca, for its part, has run into supply constraints overseas, which it has blamed on manufacturing shortfalls at a facility in Belgium. Emergent is only manufacturing AstraZeneca's shot for the U.S. market, and Kirk didn’t flag any problems unique to the company's vaccine—instead singling out the breakneck speed at which vaccine developers and manufacturers have mobilized during the pandemic.
With both partners, Emergent effectively condensed what would have been a two-year deal under normal circumstances into a matter of months, Kirk said. Still, the company has experience overcoming manufacturing challenges and boasts north of 22 years in the public health preparedness field, he added. Plus, Emergent has been beefing up its pandemic response capabilities since long before the novel coronavirus began infecting humans.
Emergent's Baltimore Bayview facility is the "epicenter" of the company's pandemic work, Kirk said. In 2012, the company inked a partnership with the HHS’ Biomedical Advanced Researched and Development Authority (BARDA) to expand that facility as a pandemic response site. It was built out originally to tackle a potential flu pandemic and has been used since to mount responses against Zika and Ebola, Kirk said.
As the current pandemic unfolded, BARDA returned to its old ally, ponying up $628 million to help Emergent scale up production of COVID-19 vaccines. Officials earmarked around $542 million for bulk manufacturing capacity at Emergent’s Bayview facility, while the remaining $85.5 million would boost fill/finish capacity at plants in Baltimore and Rockville, Maryland. That contract came courtesy of the Trump administration's Operation Warp Speed initiative to speed development and manufacturing of promising vaccine COVID-19 candidates.
While a new administration has rolled into the White House since Emergent’s government contract in June, not much has changed from the company’s perspective, Kirk said. Emergent has an OWS representative in-plant and is interacting with the same people, like the effort’s chief operating officer, Gen. Gustave Perna. Nothing has “materially changed” on that front, as the company continues to do “as much as we can as fast as we can,” Kirk said.
Emergent’s plants are now running 24/7 to meet the looming demand for Johnson & Johnson and AstraZeneca’s shots, Kirk said, work that the manufacturing exec figures goes largely unrecognized compared to the efforts of frontline workers.
“There are two fronts on the fight against COVID. There’s the much-needed healthcare workers and first responders who are on the frontlines of saving lives,” he said. “And there’s the oftentimes unnoticed second front—those who work day in, day out in facilities like Emergent, to contribute to the manufacture and development of these critically-important vaccines and therapeutics that could make an impact on stemming this pandemic.”