SAN FRANCISCO—GlaxoSmithKline’s Shingrix has generated blockbuster sales quickly after its launch, but numbers touted by the drugmaker this week show the size of the remaining opportunity—and how much supply constraints have held the rollout back.
Glaxo estimates about 115 million people in the U.S. alone are eligible for the shingles vaccine, which requires two doses two to six months apart. The company has reached about 11 million with at least one dose, execs said at the annual J.P. Morgan Healthcare Conference, meaning there are still more than 100 million eligible recipients in the U.S. alone.
In 2018, during its first full year on the market, Shingrix passed the $1 billion mark as the launch roared to life. During the first nine months of 2019, sales reached $1.67 billion.
Shingrix won U.S. approval in October 2017, and, days later, the Centers for Disease Control and Prevention vaccine advisers recommended it for adults 50 and older with healthy immune systems. That strong recommendation caught the U.K. drugmaker unprepared to met demand.
The rollout has surpassed early expectations, but supply constraints have forced GSK to limit deliveries. With its current manufacturing network, GSK can produce “high-teen millions” of doses per year, but that isn’t even meeting U.S. demand. It’s far short of what’ll be needed to fuel a global rollout.
The company is “looking everywhere” to increase capacity, but it’s started to hit a “bottleneck,” GSK’s vaccines president Roger Connor told FiercePharma at JPM. Connor, who previously ran GSK’s pharma manufacturing, took the company's top vaccines post in 2018.
While GSK is making incremental gains—the company recently pledged a $100 million investment in Montana—GSK's main capacity expansion will come in the form of a new plant slated to come online in 2024, Connor said. When the drugmaker opens the plant, it expects a “tens of millions” increase in dose capacity.
The complex supply chain features multiple sites at multiple locations around the world, and it’s further complicated by the fact that the vaccine is made up of two components—the antigen and the adjuvant, Connor said.
Before it can open the new site, GSK is doing what it can with current supply. The drugmaker has prioritized people who have received their first dose, and it's moved to increase supply visibility through an online tracker. The company isn't yet advertising in the U.S.
As for future launches around the world, those will mostly have to wait as the company is taking a "thoughtful" approach to the global rollout.
“We don’t want to launch and let down our patients and the markets where we have launched first,” he added. “We’ll take our time and do it appropriately.”
Of course, GSK has big ambitions for the vaccine in the years to come. It’s planning to kick off “phased launches” in China and Japan and is also exploring the shot in people under 50 with compromised immune systems. The vaccine will be a growth driver for "years to come," Connor said.