According to new research, Merck's investigational, 9-valent HPV vaccine has the potential to block about 90% of invasive cervical cancer cases worldwide. But realizing that potential will be no piece of cake.
Merck's investigational, 9-valent HPV vaccine has the potential to block about 90% of invasive cervical cancer cases worldwide, new research shows. But getting there will be no walk in the park. First, the company will have to solve some uptake problems that have been plaguing the candidate's predecessor, Gardasil, since it rolled out in 2006.
The debate around use of Merck's Gardasil in the United Kingdom is ratcheting up ahead of a meeting of the Joint Committee on Vaccinations and Immunisation (JCVI) in October.
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.