Mounting evidence of the effect of Gardasil, a vaccine against types of human papillomavirus (HPV), on the risk of cervical and head and neck cancer has led to increased demand for the product, as Merck CEO Ken Frazier explained during a presentation at the J.P. Morgan Healthcare Conference.
Frazier said, “The fact of the matter is that demand has skyrocketed over the past few years.”
Merck, known as MSD outside of North America and Mexico, has struggled to keep pace with demand, despite doubling capacity at its existing facilities in recent years. Late last year, a World Health Organization advisory group responded to the shortfall in capacity by asking countries to stop immunizing boys with Gardasil until there are enough vaccines to protect all girls.
Efforts to close the gap between supply and demand are underway, with Merck looking to contract manufacturing organizations (CMO) to make up some of the shortfall in capacity.
Frazier said, “We're doing everything we can with our existing facilities, and with some use of some qualified contract manufacturers.”
Coupled to efforts to address bottlenecks in the current process, Merck’s collaborations with CMOs could help to increase the availability of Gardasil.
However, Frazier thinks there is only so much Merck can achieve by increasing output at its current sites and working with CMOs, meaning the changes that will significantly increase capacity are still a few years away.
Frazier said, “I think where you will see a real inflection point is we're going to bring on two new bulk manufacturing facilities in the 2023 timeframe. We'll be able to address much more of the world's needs.”
Merck expects the opening of the two new facilities to take care of the capacity constraints, for the most part, and position it to seize what it sees as a significant, long-term opportunity.
Demand for Gardasil could continue to rise as vaccination rates in girls increase and more countries start administering the product to boys.
Other companies may try to compete for the market but Merck thinks it is well placed to hold off any rivals. Frazier called Gardasil “an extremely complex vaccine to manufacture,” adding to confidence that immunization against HPV will be “a great opportunity for an awful long time.”
GlaxoSmithKline used to compete with Merck for the US market but stopped selling its HPV vaccine, Cervarix, in the country after failing to generate sufficient demand. Last year, GSK took a step toward reentering the market by teaming up with Xiamen Innovax Biotech to develop a HPV vaccine.
