Gardasil® is the only HPV vaccine to have clinical efficacy and safety for women up to 45 years added to its product information. Gardasil® is a four-type (6,11,16,18) HPV vaccine. In addition to unsurpassed and sustained cervical cancer protection, Gardasil® can protect from cervical, vulvar and vaginal pre-cancer, and from genital warts caused by HPV types 6, 11, 16 and 18. These four types together cause the vast majority of HPV-related genital diseases.1,3,4,5
In twin votes likely to add considerable force to U.S. marketing efforts for HPV vaccines, an FDA expert panel has voted to back GlaxoSmithKline’s long delayed application to market its HPV vaccine Cervarix to women and soon after supported Merck’s application to extend the use of Gardasil to males. Glaxo shares gain 0.5 pct, Merck shares gain 1.9 pct.
Fresh controversies are heating up over the marketing of products to prevent cervical cancer The U.S. Food & Drug Administration is gearing up to make critical decisions about two controversial vaccines. On Sept. 9 an FDA advisory committee will consider whether Merck (MRK)’s Gardasil, given to girls to prevent cancer-causing human papilloma virus (HPV), should [...]
During Merck’s recent earnings call, EVP Ken Frazier touted the Gardasil push, saying he expected “sequential growth” in the vaccine’s sales “as we leverage the back-to-school season.” Second-quarter sales amounted to $268 million, down 28 percent from the same period last year and 18 percent from two years ago.But–and this is a big ‘but’–Frazier also said during that call that the 13-to-18-year-old market for Gardasil has already peaked. So despite the back-to-school campaign, Merck is looking outside that age group for any real growth in the vaccine. Frazier said the company is “firmly committed to achieving greater vaccination rates in the 19-to-26 age group.” And it’s still hoping for new indications–for boys and for women up to age 45–from the FDA.
So why is it that USA citizens in many states have the option to choose whether they or their children have the HPV vaccine but immigrants can not? In order to become a permanent, legal resident of the U.S, immigrants now must receive a vaccine that is not required of U.S. citizens. This is like saying these people are less important or more likely to be infected. This surely is wrong.
Earlier this week the Journal of the American Medical Association published an analysis of safety data that found the most common serious side effect was fainting, though some more severe adverse event occurred in Gardasil patients, including more than two dozen deaths. But the FDA and CDC say there’s no evidence the deaths or other severe effects were actually caused by the shot, and the agencies emphasize that they have reviewed the same safety data repeatedly.
The latest issue of JAMA delivered a mixed blessing to Merck’s Gardasil. In a headliner study published by the Journal of the American Medical Association, the side effects of the human papillomavirus shot were deemed reasonable. Serious adverse events cropped in up those who got the vaccine–including some 32 deaths and two cases of Lou Gehrig’s disease–but there’s no evidence the shot actually caused them. The most common complications were fainting and clot risk.
I received an email from my ICAP associate, Christina England today. Her message explained a mystery I have been trying to solve for the past week. My site stats have indicated a large number of hits from Russian ISPs and those visitors spending time investigating my article archive. Christina noted the same site visitor anomalies and traced the traffic back to http://www.oodvrs.ru/article/index.php?id_page=47&id_article=940 and found her article about ICAP communications with the German Scientists of RKI concerning the safety of the HPV vaccines Gardasil and Cervarix. This article tracks back to our papers. It is amazing but our message has been have been translated into Russian. The word is getting out there yippee! Congrats to Christina!
Possible positive drivers for Merck this quarter might be seen in its Singulair and Januvia sales. Weighing on this quarters earnings will be the loss of patent protection on Fosamex and slower Gardasil sales. Sales of cholesterol drugs Vytorin and Zetia, co-marketed by Schering-Plough (SGP), might also be disappointing especially in a weak economy with cheaper alternatives.
GlaxoSmithKline’s cervical cancer vaccine Cervarix has won a green light from the World Health Organisation (WHO) for use in developing countries, although how the shot will be paid for has yet to be resolved. WHO “prequalification” is necessary for UN agencies and the non-profit GAVI Alliance to purchase the vaccine, and Glaxo said it hoped the move would help speed access to Cervarix globally.
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