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Information to Applicants about the GARDASIL® Access Program Under the GARDASIL® Access Program Merck & Co., Inc. (Whitehouse Station, NJ, USA) has pledged to make available at least 3 million doses of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant] over the next five years for use in projects in eligible low income countries throughout the world. GARDASIL® helps prevent cervical cancer caused by HPV types 16 and 18, which Historically, there has been a significant delay between the introduction of new vaccines in developed and developing countries. The GARDASIL® Access Program strives to overcome the challenges to achieving vaccine access in developing world nations and empowers resource-poor nations and their partners to develop programs to bring this vaccine to people in need. The GARDASIL® Access Program will provide GARDASIL® to programs in eligible countries to allow countries to gain experience in the implementation of such programs. It does not aim to cover nationwide HPV vaccine programs. The program will draw upon the learnings and experiences from participating organizations and seek to contribute to knowledge on how to successfully implement vaccine access The GARDASIL® Access Program, which is planned to run over a 5-year period, is made possible by a pledge from Merck & Co Inc. (Whitehouse Station, NJ, USA), and is overseen by Axios Healthcare Development (AHD), a US non-profit organization. AHD administers the donation program, reviews and approves applications, and ensures prompt delivery of the vaccine to the recipients, with the technical assistance of Axios International, a public health consultancy specializing in developing and emerging GARDASIL® will be made available to eligible institutions that are nationally recognized and meet the GARDASIL® Access Program eligibility criteria. The qualifying institutions could fall under any of the NGOs or charitable organisations involved in vaccination services and/or cancer management Institutions will be required to present a letter of support from the Ministry of Health. The GARDASIL® Access Program will provide information and guidelines for health care workers on how to GARDASIL® is a registered trademark of Merck & Co., Inc, Whitehouse Station, NJ, U.S.A What is GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine,
Recombinant]?
GARDASIL® is a non-infectious recombinant quadrivalent vaccine prepared from the highly purified virus-like particles (VLPs) of the major capsid L1 protein of HPV types 6, 11, 16 and 18. The quadrivalent HPV VLP vaccine is a sterile liquid suspension that is prepared by combining the adsorbed VLPs of each HPV type and additional amounts of the aluminum containing adjuvant and the final purification buffer. The VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease. GARDASIL® is licensed by FDA for use among females 9 to 26 years of age to prevent cervical cancer, precancerous or dysplastic lesions, and genital warts caused by HPV types 6, 11, 16 and 18. GARDASIL® is contraindicated in individuals who are hypersensitive to the active substances or to any of The health care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL® should continue to undergo cervical cancer screening per standard of care. GARDASIL® is not recommended for use in pregnant women. GARDASIL® may not result in protection in all vaccine recipients. GARDASIL® is not intended to be used for treatment of active genital warts; cervical cancer; CIN, vulvar interepithelial neoplasia (VIN), or vaginal interepithelial neoplasia (VaIN). GARDASIL® has not been shown to protect In clinical studies for GARDASIL®, vaccine-related adverse experiences that were observed at a frequency of at least 1.0 percent among recipients of GARDASIL® and also greater than those observed among recipients of placebo, respectively, were pain, swelling, erythema, fever, nausea, pruritis and dizziness. In addition, common post-marketing reports include vomiting and syncope. GARDASIL® is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL® should be administered in three separate intramuscular injections in the upper arm or upper anterior thigh over a six- month period. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose. Please refer to the Prescribing Information for more information on GARDASIL®. How to Apply
Axios International will send out notifications to institutions to submit their proposals/applications twice a
year. For 2008, the proposal submission deadline is 1st of September 2008. Applicants who miss the
deadline for proposal submission may wait for the next call. However, they may submit their proposals on the understanding that they will only be reviewed at the next board meeting. Proposals received after the deadline will be kept until the next submission date is due. Activity
Deadline / Time Frame
Applicants interested in applying for GARDASIL® must complete a simple application that clearly demonstrates their proposal on how the institution intends to implement the program, ensure safety injection procedures and conduct monitoring and evaluation process. The application/proposal will be reviewed by a team of competent and experienced independent reviewers and an AHD Advisory Board. Applications can be accessed on any of the following websites: • Request the application by fax or post to Axios International. For more information about GARDASIL® Access Program and the eligible countries You may also download and print out this form from this web site. If you do not have access to the Internet, or would like an electronic copy of this document, please contact Axios International. Email, fax or post
The review process
As soon as the application is received by Axios International, a rapid screening will be performed to ensure that the information provided is complete. Applicants will be contacted within five (5) days of receipt of their application and will be informed about the progress of their file. Additional information may be requested at this stage. If the application is complete, independent experts, commissioned by AHD, will review the proposal and give their recommendations to the Advisory Board. The Advisory Board will make a final review of the application/proposal at their bi-annual board meeting and give a recommendation to AHD. 1. The proposal is satisfactory and the Institution is recommended for inclusion in the GARDASIL® 2. Additional information or clarifications are required before recommendation can be made When the application is approved
The applicant will receive an official letter to confirm that AHD has approved the Institution for inclusion in the GARDASIL® Access Program. Details concerning the quantity of GARDASIL®, timescale, shipping schedules and shipping procedures will be defined in the approval note. The applicant should provide the exact shipping address and any other relevant information necessary for sending the vaccine to the country when completing the application. The applicant will be notified of shipment schedule as soon as the information is received from the shipper. Logistics
The administration and use of GARDASIL® requires the donation product to be approved for use in the country. If the vaccine is not approved for use, the applying institution must have a special import license and/or a waiver letter from the government to import this donation. AHD, supported by Merck & Co., is offering GARDASIL® free-of-charge and will cover the shipping costs and insurance up to the indicated port of entry in the countries. The recipient is responsible for all other Dialogue and Reporting
There will be an ongoing dialogue with institutions participating in the program. In addition, a progress report should be sent to AHD 6 months after receipt of the vaccines. However the institution can submit an earlier report in case of a need for a re-supply. A standard template will be provided to each institution to facilitate the reporting process. Main Indicators tracked will concern GARDASIL® data consumption, number of people vaccinated (1st, 2nd and 3rd injections), number of centres involved, etc. The information from the application and the date of the regular progress reports will be entered into a database maintained by AHD. This database will provide data on the number of institutions participating in the GARDASIL® Access Program, the reported number of patients receiving GARDASIL® in each country and other relevant Re-Supply of GARDASIL®
Once an institution has received the first donation of GARDASIL®, the request for re-supply will be automatic based on numbers reached compared to those approved by the advisory board. The donor commits to provide the complete dose of GARDASIL® (3 schedules) to all patients that have received the first dose through the application process. The institution will be asked to provide a progress report detailing the quantity of GARDASIL® requested, the quantity used and number of patients reached as justification. AHD reserves the right to amend requests based on information collected on the program and usage of product. Eligible Countries
The following countries are eligible to participate in the program:

Source: http://gardasildonation.org/x/File/Information%20to%20Applicants.pdf

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