Gardasil, the darling of Merck's vaccines unit, has proved a valuable moneymaker, hauling in $2.17 billion worldwide last year to rank second on the world's best-selling vaccines list. But lagging U.S. vaccination rates against human papillomavirus, for which the jab is intended, are preventing the shot from achieving its bigger sales potential.
Worries over Gardasil's safety are just one of the issues that have hampered uptake of Merck's best-selling vaccine for HPV. But now, a study published in JAMA says patients need not worry about an increased risk of deadly blood clots.
Gardasil may be the No. 2-selling vaccine in the world, but its marketers have struggled against a variety of barriers to get it where they want it in terms of uptake. Now, a new anal cancer indication in Europe may help with that goal.
Back in 2012, the GAVI Alliance announced plans to help immunize 30 million girls in 40 countries with HPV vaccines by 2020. Wednesday, the Children's Investment Fund Foundation chipped in toward that goal with a $25 million investment that will be matched through the U.K.'s Department of International Development.
Research has shown that HPV vaccines don't lead to risky sex. But that doesn't mean they pass every patient's morality test. On the contrary, moral concerns about Merck's Gardasil were the greatest barrier to immunization among college freshmen, a Michigan study found.
Some insurance companies have put up roadblocks, labeling the vaccine--which can cost up to $500 for three doses--"experimental" for boys.
Now that the European Commission has officially approved a two-dose Gardasil regimen for early teens, Merck and Sanofi will see the number of shots per patient fall. But that doesn't mean they'll necessarily take a sales hit, with the move potentially expanding overall access and providing a bump both drugmakers could use.
If the U.K. adopts the two-shot model, it may use the cash it saves to vaccinate boys against HPV.
The success of Australia's HPV vaccination catch-up program has given the country a world-leading trove of real-world data on the effectiveness of Merck's Gardasil. By mining this database, researchers have estimated the vaccine halves the risk of young women developing high-grade cervical abnormalities.
The FDA accepted Merck's application for V503, a next-generation HPV vaccine designed to usurp Gardasil, setting the stage for a near-term approval and some likely blockbusting sales figures.