Merck siphons off Gardasil CDC supplies again as global sales surge

Gardasil 9
Global sales of Gardasil and Gardasil 9 were up 27% in Q3, although only 3% in the U.S. The HPV vaccines have turned int more than $3 billion in sales through September. (Merck)

Merck & Co. won’t be able to fully meet global demand for HPV vaccine Gardasil until after 2023 when it completes production of a couple of manufacturing plants. So for now, the drugmaker is again turning to the CDC to borrow doses. 

The company this month borrowed Gardasil 9 doses from the U.S. Centers for Disease and Control and Prevention’s (CDC) Pediatric Vaccine Stockpile to help cover vaccinations in the U.S., which will allow Merck to produce more for other parts of the world where demand is outrunning supply. The move will cost Merck about $120 million in Q4 sales, it said. 

“These doses will be allocated to support routine vaccination in the United States and will allow the company to manufacture doses for other parts of the world, including regions where some of the most vulnerable populations live,” the Kenilworth, New Jersey-based company said in its Q3 earnings. 

Whitepaper

Simplify and Accelerate Drug R&D With the MarkLogic Data Hub Service for Pharma R&D

Researchers are often unable to access the information they need. And, even when data does get consolidated, researchers find it difficult to sift through it all and make sense of it in order to confidently draw the right conclusions and share the right results. Discover how to quickly and easily find, synthesize, and share information—accelerating and improving R&D.

RELATED: Merck to build Gardasil 9 plant and add 425 jobs, but will cut 150 elsewhere

Sales of Gardasil hit $1.32 billion in Q3, making Merck’s Human Papillomavirus (HPV) vaccines its second best selling products behind cancer phenom Keytruda. The Gardasil portfolio has turned in just over $3 billion in sales through September. While Gardasil sales globally were up 27% in Q3, growth in the U.S. was only 3%

With demand for Gardasil building faster than Merck can produce it, the company this year said it would invest about $1.68 billion on two U.S. plants to significantly boost Gardasil production. Those facilities won't come online for several years.  

RELATED: Hack forces Merck to borrow Gardasil doses from CDC stockpile, slamming Q3 sales

“So, in 2023, that is when we will expect to be able to ramp our supply up to meet the ex-U.S. demand,” Frank Clyburn chief commercial officer, told analysts. “We do believe we can still grow Gardasil over the next several years as we continue to match and move supply to match our demand around the world.” 

Merck does not yet know if that will require hitting up the CDC again for more supplies. Merck spokeswoman Pamela Eisele in an email today reiterated the company is investing in new production "with urgency" to meet the growing global demand.

"We’ll continue to monitor our supply situation and determine whether future borrowings are necessary or when the appropriate time would be to replenish the stockpile," she said. 

Merck has had tap the CDC’s Gardasil stockpile before to cover a significant shortfall. The company borrowed $240 million worth of Gardasil doses in 2017 after a cyberattack crippled its production for several months and reduced sales of the HPV vaccine by 22% in one quarter.

Suggested Articles

The efficacy between Keytruda and FerGene's nadofaragene firadenovec look comparable in their studies, though Merck has at least one upper hand.

Thursday, the FDA approved the first three generic versions of Gilenya, but they may not hit the market anytime soon due to ongoing litigation.

Gilead is hoping to score a patent extension on TAF meds, but patient advocates say that would reward conduct that harmed patients.