Gardasil Vaccination Effectiveness as Low as 60% for Females, 51% for Males: Study

As a growing number of families file Gardasil lawsuits against Merck, alleging that the drug maker has withheld important information about the risks associated with the widely used vaccination against the human papillomavirus (HPV), a new study raises questions about the effectiveness of the vaccine for many children.

Researchers with the U.S. Centers for Disease Control and Prevention (CDC) published findings in the July 2022 issue of the Annals of Internal Medicine, indicating that the HPV vaccination is having an increasing effect as more youths get it and the benefits of herd immunity increase. However, the study suggests lower-than-expected levels of effectiveness at the individual level, indicating that it may be as low as 60% for women and 51% for men.

Gardasil was first introduced in 2006, for prevention of HPV infections, which can be sexually transmitted and lead to the later development of cervical cancer. Following years of marketing by the drug maker that suggested the vaccine was safe and effective, Gardasil vaccination has been widely recommended for young girls and boys before adolescence and potential sexual activity.

While most health agencies in the U.S. still strongly encourage young adults to receive a vaccination with Gardasil, concerns have emerged in recent years that Merck failed to adequately warn about problems that may be experienced after receiving the injection.

Dozens of product liability lawsuits now allege that Merck ignored evidence that side effects of Gardasil vaccination may lead to the development of disabling autoimmune disorders, neurological side effects and other complications. Plaintiffs claim that Merck failed to adequately research the product before aggressively marketing it for use among children nationwide, and withheld important safety information from families and the medical community.

In this new study, CDC researchers used data from the National Health and Nutrition Examination Survey for the years 2003 to 2006, before the vaccine was introduced, as well as “vaccination eras” of 2007 to 2010, 2011 to 2014, and 2015 to 2018, evaluating data from sexually experienced participants between the ages of 14 and 24.

They found increasing effectiveness at the prevention of HPV in recent years, as the vaccine has become more prevalent, with herd immunity even helping to protect unvaccinated females from the cancer-causing disease. The changes were seen with quadrivalent HPV, which Gardasil is designed to prevent, and not with other types of HPV, increasing the likelihood that the impacts being seen are due to the vaccine. However, the findings also indicated fairly low rates of individual effectiveness.

“Vaccine effectiveness ranged from 60% to 84% during vaccine eras for females and was 51% during 2013 to 2016 for males,” researchers determined.

Vaccines can range widely in effectiveness. Flu vaccine effectiveness varies from year to year, based on how correctly the CDC determined which strains will be active that flu season. Vaccines for ailments like Rubella and Measles regularly exceed 90%, while the U.S. Food and Drug Administration (FDA), which approves vaccines for public use, set a threshold of only 50% effectiveness for COVID-19 vaccines, although those approved for the U.S. market tend to far exceed that number.

Gardasil Vaccine Concerns

Shortly after it was introduced, concerns about Gardasil problems emerged after one of the lead researchers responsible for developing the HPV vaccine, Dr. Diane Harper, indicated that the drug’s protection may only last a few years, suggesting that the risks may outweigh the benefits.

Dr. Harper reportedly said at a conference in 2009, that while Gardasil was tested on 15 year old girls, it is commonly being given to girls as young as nine years old. She has called for more detailed warnings to parents about the Gardasil risks and to provide additional information about the unknown long-term benefits for girls who are not likely to be sexually active for several years.

The National Cancer Institute has heralded the HPV vaccine, saying that widespread use could reduce cervical cancer deaths worldwide by as much as two-thirds. Many also suggest men get the vaccine as well in order to promote “herd immunity,” which occurs when a large enough portion of the population is vaccinated against a particular disease that they act as a firewall, preventing that disease’s spread even to those who are not vaccinated.

Last year, Gardasil brought in $5.7 billion in sales for Merck, and the company reports it is seeing a 60% increase in sales so far this year.