Merck Cancer Vaccine May Not Win Routine Use in Boys
Oct. 21 (Bloomberg) -- Giving Merck & Co.’s Gardasilvaccine to boys may not boost protection against cervicalcancer enough in girls to gain recommendation from a U.S.government program that provides free shots to 60 percentof children.
An advisory panel for the U.S. Centers for DiseaseControl and Prevention, made up of 15 doctors who provideadvice for which vaccines should be given and at what ageand dose, is set to decide today whether to urge thatGardasil be given as a routine shot for boys, and coveredby the vaccination program.
The U.S. Food and Drug Administration on Oct. 16cleared Gardasil as an effective protection for genitalwarts in boys. The vaccine works against humanpapillomavirus, or HPV, a sexually transmitted infectionthat can lead to cervical cancer in women and a rare cancerof the penis in men. Such a ruling, which would add as muchas $300 million in yearly sales, isn’t likely, said SeamusFernandez, a Leerink Swann & Co. analyst.
“We expect a permissive, not routine, vaccinationrecommendation,” Fernandez said in a note to investors.Merck may struggle selling Gardasil for boys because thepublic-health benefit may not outweigh the expense,Fernandez said.
Merck, based in Whitehouse Station, New Jersey, fell44 cents, or 1.3 percent, to $33.28 at 11:21 a.m. in NewYork Stock Exchange composite trading. The shares hadincreased 9 percent in the 12 months before today.
‘Value in Vaccinating’
“Approximately 75-80 percent of males and femaleswill acquire one or more types of HPV in their lives andHPV-related diseases cause significant personal and publichealth burden for both men and women,” said Merckspokeswoman Pam Eisele in an e- mail. “As such, we believethere is value in vaccinating both young men and women withGardasil to help protect them from certain diseases causedby HPV.”
William Schaffner, chairman of the department ofpreventive medicine at Vanderbilt University in Nashville,Tennessee, said the panel will be asking itself “if wevaccinate all the girls, how much additional benefit willwe get by vaccinating the boys?
“The answer will be ‘some,’ but at least according tothe mathematical models, it’s not huge,” he said in atelephone interview. Schaffner is not a panel member.
Decisions by the Advisory Committee on ImmunizationPractices are regularly adopted by the U.S. government.
Cervarix Vote
The committee also voted today to includeGlaxoSmithKline Plc’s competing vaccine, Cervarix, on theU.S. list of recommended vaccines for girls, to competeagainst Gardasil. Cervarix was approved Oct. 16 in the U.S.to prevent cervical cancer in females ages 10 to 25.Cervarix’s safety contributed to a regulatory delay in2007, helping give Merck a head start.
The CDC’s recommendation, once adopted, will telldoctors that both vaccines protect against cervical cancer,while Gardasil also protects against genital warts andcancer of the vagina and vulva. Language that said thepanel had no preference for either vaccine was strickenfrom the proposal after some members said wart protectionmakes Gardasil a better vaccine.
“Permissive Use”
A CDC recommendation of allowing “permissive use”for boys, where vaccination is left to a doctor’sdiscretion, may add $200 million to $300 million in annualGardasil sales by 2015, Leerink Swann’s Fernandez wrote ina note to clients on Oct. 19. Gardasil sales fell 5 percentlast year to $1.4 billion, the company has said.
It would cost more than $290,000 to vaccinate enoughboys and girls to save one year of life, compared withabout $40,000 when vaccinating girls alone, according to astudy by Harvard University School of Public Healthresearchers, released Oct. 9 in the British MedicalJournal.
Any vaccine that costs less than $100,000 per yearsaved, also known as Quality-Adjusted Life Year, or QUALY,is considered “a good deal,” Schaffner said. The QUALYmodel increases the numbers of years saved to include somebenefit for living without nuisance diseases, such aswarts.
Merck Studies
Merck’s study found it would cost about $50,000 forboth boys and girls. The Harvard and Merck studies useddifferent assumptions to reach their conclusions. TheHarvard study evaluated the cost of vaccinating 12-year-olds, while Merck studied vaccinating those ages 9 to 26.The Harvard study assumed a higher cost of $500 pervaccinated child with 75 percent effectiveness of thevaccine, while Merck’s study used a cost of $400 with 100percent efficacy.
In a Merck-funded study released last year,researchers gave 4,065 boys and men ages 16 to 26 thevaccine or a placebo, then tracked them for signs ofinfection with HPV. After about 30 months, three mengetting Gardasil developed genital warts and none had pre-cancerous growths linked to the HPV virus, compared with 28cases of warts and three pre-cancerous lesions in theplacebo group.
The vaccine committee is “faced with something quiteextraordinary: an anti-cancer vaccine that is very verysafe and by every indication is exceedingly effective,”Vanderbilt’s Schaffner said. “Over the last five and sixyears, cost-benefit analyses have played a larger andlarger role in vaccine debates. The committee has gone backand forth and really agonized about that.”
Patient Rebate
Merck will expand a patient rebate and dosereplacement program to help cover the cost of the vaccinefor 19- to 26- year-old men without health insurance andthose with private insurance with partial or no coveragefor the shots, according to a company statement.
Gardasil, which is given in three shots over a six-month period, protects against four of the most common of40 strains that can infect the genital area. More than 1million cases of genital lesions, which can lead to cancer,occur in men and women in the U.S. each year, and 30million cases occur worldwide, according to Merck.
Gardasil and Cervarix are given in three doses duringa six-month period to trigger immune responses that helpprotect against the two HPV strains responsible for mostU.S. cervical cancer cases. Gardasil also protects againsttwo additional strains of HPV that cause 90 percent ofgenital warts.
Glaxo Challenge
London-based Glaxo faces a challenge in winningdoctors’ and parents’ support for Cervarix because ofGardasil’s added protection against genital warts. Cervarixis cleared in 100 countries and had sales of 125 millionpounds ($232 million) last year, about one-sixth as much asGardasil.
While 20 million Americans are infected with HPV, mostwill be able to fight off the infection naturally,according to the National Cancer Institute. About 1 percentof sexually active men in the U.S. will develop genitalwarts from HPV, the CDC said. Gardasil is approved formales in 40 countries worldwide.
The most common side effect is fainting after gettingthe injection, followed by irritation around the skin siteand dizziness, according to a government analysis of side-effect reports. For every 100,000 shots, eight patientswill faint, seven will have reactions at the area of theinjection and seven will become dizzy, according to a studypublished in the Journal of the American MedicalAssociation and conducted by the CDC.
To contact the reporters on this story:Tom Randall in New York at trandall6@bloomberg.net;Shannon Pettypiece at spettypiece@bloomberg.net.
Last Updated: October 21, 2009 11:40 EDTSource: Bloomberg
« Back to Health News
Related News
-
Vaccine Against Virus in Girls May Be Given to Boys Oct 21, 2009 @ 09:19 AM
Gardasil, the vaccine used to immunize girls and young women against the sexually transmitted virus that causes cervical cancer, may now be given to boys and young men to protect them from genital warts, a federal advisory group recommended Wednesday.
-
Merck Cancer Vaccine May Not Win Routine Use in Boys Oct 21, 2009 @ 09:19 AM
Oct. 21 (Bloomberg) -- Giving Merck & Co.’s Gardasilvaccine to boys may not boost protection against cervicalcancer enough in girls to gain recommendation from a U.S.government program that provides free shots to 60 percentof children.
-
Merck Cervical Cancer Shot May Not Win Routine Use for Boys Oct 21, 2009 @ 09:19 AM
Oct. 21 (Bloomberg) -- Giving Merck & Co.’s Gardasilvaccine to boys may not boost protection against cervical cancerenough in girls to gain recommendation from a U.S. governmentprogram that provides free shots to 60 percent of children.
-
Merck Cancer Vaccine Fails to Win Routine Use in Boys Oct 21, 2009 @ 09:19 AM
Oct. 21 (Bloomberg) -- -- Merck & Co.’s Gardasil vaccine,used to protect girls from a virus linked to cervical cancer,shouldn’t be given routinely to boys, a U.S. advisory panelsaid.
-
Giving Gardasil to boys not cost effective: study Oct 21, 2009 @ 09:19 AM
CHICAGO (Reuters) - Vaccinating boys against the virus that causes cervical cancer and genital warts does not appear to be cost-effective, U.S. researchers said on Thursday.
