Despite successes, Merck’s Gardasil HPV/cervical cancer vaccine faces ongoing skepticism

The Centers for Disease Control (CDC) reported earlier this month that about 25% of teenage girls in the US have received at least one dose of Merck’s Gardasil vaccine, which is considered a fairly high success rate for a new vaccine. Gardasil gained FDA approval in 2006 for females between the ages of 9 and 26. However, sales of Gardasil have dropped in 2008 due to a variety of criticisms including cost, effectiveness, and potential side effects.

The vaccine is designed to ward off four out of six strains of human papillomavirus (HPV), which are believed to be a primary cause of cervical cancer, and requires three doses at a cost of about $120 per dose. While the CDC recommends the vaccine for girls 11-12 (as well as “catch up” vaccines up to age 26), health insurance companies don’t always cover vaccines, and Gardasil’s newness and cost have many women hesitating to receive the vaccine. State and government agencies that have mandated the vaccine for certain groups (such as immigrants and Texas teens) have also experienced a good level of backlash over requiring such a high-cost and highly debated vaccine.

Also at issue is whether the vaccine will prove to serve its purpose. Scientists wonder whether its effectiveness will wear off and require booster vaccines in later years. And while the vaccine is believed to be effective in preventing HPV, there is a good amount of speculation over whether a cancer prevention vaccine is even possible at this time.

As with all new vaccines and medicines, it is difficult to foresee what side effects could come to light over time. A CDC report released last week stated that, based on an evaluation of adverse event reports, Gardasil is safe to use and is effective against HPV. The report shows that serious events and deaths associated with use of the vaccine have largely been attributed to other causes. While the report is reassuring, the CDC’s continued monitoring of the vaccine is necessary as some side effects can remain undiscovered for years.

GlaxoSmithKline (GSK) also has a cervical cancer vaccine (Cervarix) on the market in other countries that is under FDA review for sales approval in the US. Whether the GSK vaccine has any success in the market partially depends on how much acceptance grows for the Gardasil vaccine. Merck itself has a lot riding on the vaccine’s success.

Whether the vaccine has any effect on cervical cancer infection rates can only be proven over time, but when it comes down to it, the vaccine’s apparent success at preventing HPV is a valuable health benefit on its own and makes it a viable candidate that women in the recommended age group should consider when weighing their health care options.

Anne Law

Anne Law has been a member of the Hoover's editorial department for nine years and has covered a wide range of industries, from utilities and schools to paper and food. The variety has left her with an odd mix of passions including pharma snooping and alternative energy fad following.

Read more articles by Anne Law.

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Comments

  1. Denise Melton says:

    On Feb 22, 2008 My granddaughter was found dead two days after the 3rd Gardasil shot. A perfectly healthy 17 year old in the begining of life, cut down. We have done so much research since her death and have found so many adverse reactions and 30 known deaths. Known deaths!!!!! How many unknown deaths. So many are not reported by Dr’s. Not even 10% are reported. If we had known before the vaccine was given to her. Why are they not telling families of the reactions before this vaccine is given? Letting the families find out the evident cause was the Gardasil when the health problems or Death occur. I am telling all who will listen that Gardasil is not all that safe for our children. There are horrible side effects and they should know of this.

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