By Norma Erickson, President of SaneVax Inc.
On 5 October 2005, eight months prior to FDA approval of the HPV vaccine Gardasil, the Pan American Health Organization (PAHO, a regional office of the World Health Organization) sponsored a meeting in Washington D.C. The theme of this meeting was, Partnering for HPV Vaccine Introduction. According to the final report issued after this meeting, its purpose was to, “accelerate and strengthen the dialogue between invited partner agencies regarding their interests and plans related to the introduction of Human Papillomavirus (HPV) vaccines.”
Of course, both potential vaccine suppliers, Merck and GlaxoSmithKline, were ‘invited.’ In addition to the potential suppliers, representatives from the following ‘partnering agencies’ were in attendance:
• The Pan American Health Organization (PAHO)
• The World Health Organization (WHO)
• The International Union Against Cancer (UICC)
• The American Cancer Society (ACS)
• The United States Agency for International Development (USAID)
• The United States National Cancer Institute (NCI)
• The United States Centers for Disease Control and Prevention (CDC)
• Program for Appropriate Technology in Health (PATH)
• The Bill and Melinda Gates Foundation
After a brief introduction, representatives of PAHO outlined the activities their organization had already conducted in preparation for the introduction of the yet to be approved HPV vaccines. Then, Merck and GSK each made a brief presentation regarding their respective-proposed HPV vaccines, Gardasil and Cervarix.
The presentations made by Merck and GlaxoSmithKline raised the following questions from their ‘partnering agencies’:
• Question 1: How would vaccine efficacy be assessed in young children in the absence of CIN lesions?
• Question 2: How will the issue of consent for HPV vaccine trials in adolescents be handled?
• Question 3: What is the duration of protection conferred by these vaccines?
• Question 4: What level of antibody is actually protection?
According to the final report on this meeting, published by PAHO, the answers given to these questions were sketchy at best. That may be understandable, considering HPV vaccines had not yet been approved by the FDA. However, it is not acceptable for these questions to remain unanswered five years post-FDA approval.
SaneVax Inc. has the following concerns regarding the above-stated questions:
Question 1: Although both vaccine suppliers indicated they were ‘conducting immune-bridging studies,’ the question posed has still not been answered. There is no adequate reliable method of testing HPV vaccine efficacy to this day. Using CIN lesions is not reliable, considering they frequently reverse on their own, without medical intervention. Efficacy against vaccine-relevant HPV genotypes could theoretically be tested via DNA sequencing, but that option is not readily available to medical consumers.
Question 2: Both vaccine suppliers indicated they required consent from the parent, or legal guardian, as well as permission from the subject when trials were conducted with participants below the legal age of consent. This clearly was not the case in India, April 2009, when clinical trials were halted because of alleged ethics violations including boarding school administrators being allowed to give consent for all of the girls attending their school, and other consent forms being returned with a thumbprint (clearly indicating the person granting consent could not read the consent form).
Question 3: The answer provided by both vaccine suppliers then (information on duration of protection is unavailable at this time), is similar to the one they give today. Both vaccines have been approved for nearly five years. One of the suppliers is already talking about the potential need for a booster shot to maintain protection. Duration of protection is still unknown.
Question 4: The answer given at the time by the vaccine suppliers was, “There are currently no established serologic correlates of protection.” What that means is no matter how many antibodies are produced and circulating in a vaccinated person’s bloodstream, no one knows if you are protected. Serologic correlates have still not been established.
Three of the four questions posed at the meeting are basic questions that should have been answered prior to FDA approval of either HPV vaccine. There must be a reliable way to determine efficacy and antibody level required for protection with any vaccine. These should be determined prior to marketing. Every vaccine carries some risk for some people. If efficacy cannot be determined with accuracy you have nothing left but risk.
Duration of protection should also be well established prior to marketing for the same reason efficacy needs to be determined. No one can logically determine if a vaccine is cost effective when they do not know the duration of protection.
One has to wonder why nine prestigious organizations, responsible for the health and well-being of millions of people, would agree to stand behind and promote any vaccine that could not clearly and scientifically demonstrate the answers to very basic questions regarding the product’s efficacy.
There are only a couple of options available to medical consumers to determine HPV vaccines’ efficacy. One, wait 20 or more years to see if HPV vaccines actually make an impact on cervical cancer rates; or two, demand post licensure monitoring that includes HPV DNA sequencing to find out if the vaccines are actually making an impact on vaccine-relevant genotypes of HPV.
The SaneVax Team votes for – No adequate post-licensure monitoring – No marketing!