Merck is committed to registering our vaccines worldwide, quickly and transparently—including in developing countries and all countries in which we conduct clinical trials.

Registration & Prequalification

GARDASIL^® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18)] is currently registered in 125 countries, and ROTATEQ^® (rotavirus vaccine, live, oral, pentavalent) is registered in more than 100 countries. In addition to registration, World Health Organization (WHO) prequalification is an important step in Merck's access efforts, signifying that vaccines meet the quality, safety and efficacy requirements of UN agencies, including those of UNICEF and the Pan American Health Organization (PAHO). Merck received WHO prequalification for ROTATEQ in October 2008, MMR^®II (Measles, Mumps, and Rubella Virus Vaccine Live) in December 2008, and GARDASIL in May 2009.

Pricing

In the developing world, Merck offers ROTATEQ and GARDASIL at an access price that is significantly less than the price of these vaccines in developed markets.

The access price is exclusive to the public sectors of Global Alliance for Vaccines and Immunization (GAVI)-eligible countries, meeting the needs of the developing world by facilitating access to these innovative vaccines in the poorest countries, while making sure they remain affordable and sustainable in the long term. We believe that our pricing approach contributes to wider access to our vaccines, while taking into account our need to continue investing in vaccine research, development and production. For more developed, middle-income countries, Merck provides our vaccines at tiered prices in relation to a country’s ability to pay.

In April 2012, GAVI announced that eligible countries would be able to apply for funding to allow for broader access to HPV vaccines. Merck supports continued efforts to increase access to HPV vaccines and continues to work with the GAVI Alliance and other partners to evaluate what can be done to increase long-term sustainable access in GAVI-eligible countries.

In addition, we continue to look for novel ways to further reduce the cost of our vaccines in developing countries. An important approach is to pursue manufacturing efficiencies and explore potential partnerships with low-cost manufacturers to bring down the cost of the vaccine.

Merck has a long history of progress in this area. Our Hepatitis B license of technology to manufacturers in China dates back to the 1990s and has resulted in over 100 million doses of recombinant Hepatitis B vaccine being produced by our collaborators each year to address the public health burden of this Hepatitis B in China.¹

In August 2011, Merck announced a new agreement to work with the Serum Institute of India Limited, an Indian company, to develop and commercialize a pneumococcal conjugate vaccine (PCV) for use in emerging and developing countries.