Merck & Co., Inc. announced today that both ROTATEQ (rotavirus vaccine, live, oral, pentavalent) and GARDASIL [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] have now been adopted by all 55 U.S.-based immunization projects of the Centers for Disease Control and Prevention's (CDC) Vaccines for Children (VFC) program. The 55 Immunization Projects include the 50 states in addition to city programs in Washington DC, New York City, Philadelphia, Chicago, and San Antonio."This milestone is an important step in Merck's ongoing commitment to make our vaccines available to all children who need them, regardless of income," said Mark Feinberg, M.D., Ph.D., vice president of policy, public health and medical affairs, Merck Vaccines. "The adoption of ROTATEQ and GARDASIL by all 55 immunization projects further demonstrates the value these vaccines provide, and we applaud the projects for their prompt action in ensuring timely access to these important vaccines."
Since 1994, the VFC program has provided vaccines to children who are Medicaid-eligible, uninsured, underinsured (when seen at a Federally Qualified Health Center or Rural Health Clinic), or Native American, providing coverage for many who do not have private health insurance.
ROTATEQ is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3 and G4 when administered as a three-dose series to infants between the ages of six to 32 weeks. GARDASIL is indicated for girls and women ages nine to 26, for the prevention of cervical cancer; cervical pre-cancers (CIN 2/3 and AIS), vulvar pre-cancers (VIN 2/3) and vaginal pre-cancers (VaIN 2/3) caused by human papillomavirus (HPV) types 16 and 18 and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18. HPV types 16 and 18 account for approximately 70 percent of cases of cervical cancer, non-invasive cervical cancer (CIN 3, AIS), VIN 2/3 and VaIN 2/3, and account for 50 percent of CIN 2 lesions. HPV 6 and 11 cause approximately 90 percent of genital wart cases.
Merck's commitment to global vaccine access
Merck has submitted applications to seek World Health Organization (WHO) prequalification status for ROTATEQ and GARDASIL as part of the Company's commitment to making its vaccines available in the developing world. Applications for both vaccines have been accepted by WHO and are being reviewed. WHO prequalification verifies that vaccines meet the qualifications of quality, safety and efficacy for procurement by U.N. agencies, including UNICEF and the Pan American Health Organization (PAHO), and is an important step towards providing global access to these vaccines. "Merck is pursuing a systematic, thoughtful approach to the global introduction of ROTATEQ and GARDASIL - partnering with WHO, the GAVI Alliance and other international organizations, conducting global clinical trials and demonstration projects, and committing to making ROTATEQ and GARDASIL available at dramatically lower prices in GAVI-eligible countries," said Margaret G. McGlynn, president, Merck Vaccines.
Merck has made an important stride towards making ROTATEQ available in the developing world through its partnership with the Nicaraguan Ministry of Health (MOH) which was announced in September 2006. Through this joint project, aimed at demonstrating the public health impact of a full rotavirus vaccination program, all infants born in Nicaragua in a three-year period will receive free doses of ROTATEQ. This program represents a significant opportunity to add to the evidence base supporting the efforts of the global public health community to accelerate the introduction of routine rotavirus vaccination in resource-poor countries.
It is estimated that more than 60,000 infants have been vaccinated with ROTATEQ in Nicaragua in the six months since this partnership was initiated. The Nicaragua Rotavirus Vaccine Project marks the first time that a vaccine was introduced in a GAVI-eligible country in the same year it was approved by the U.S. Food and Drug Administration (FDA).
In December 2005, Merck entered into a partnership with PATH, an international non-profit group, to conduct clinical trials of ROTATEQ in Africa and Asia. The first infant was enrolled in a clinical trial in Bangladesh in March 2007. Trials are also under way in Ghana and Mali. Trials in Kenya and Vietnam are expected to begin this year.
Merck will also provide GARDASIL and technical support at no cost to PATH to support demonstration studies in India, Peru and Vietnam. These studies are designed to accelerate the availability of cervical cancer vaccines in the most impoverished nations. In addition, Merck is working with India's Council of Medical Research to study GARDASIL in India.
Merck has also initiated a new U.S. patient assistance program for vaccines for adults. Through this program, currently available in private physicians' offices and private clinics, Merck is making available, free of charge, GARDASIL and other Merck vaccines indicated for use in eligible individuals ages 19 and older who are uninsured and who are unable to afford vaccines.
Both vaccines were approved for use in the U.S. in 2006 and embraced by physicians, parents and public health authorities. The CDC recommends both vaccines as part of their recommended immunization schedule.
Select safety and additional information about ROTATEQ
ROTATEQ should not be administered to infants with a demonstrated history of hypersensitivity to any component of the vaccine.
No safety or efficacy data are available for the administration of ROTATEQ to infants who are potentially immunocompromised, including those who have received blood products within 42 days of vaccination.
More than 71,000 infants were evaluated in three placebo-controlled clinical trials. Serious adverse events occurred in 2.4 percent of recipients of ROTATEQ when compared to 2.6 percent of placebo recipients within the 42-day period of a dose of ROTATEQ. Hematochezia, reported as a serious adverse event for ROTATEQ compared to placebo, was less than 0.1 percent vs. less than 0.1 percent. The most frequently reported serious adverse events for ROTATEQ compared to placebo were bronchiolitis (0.6 percent vs. 0.7 percent), gastroenteritis (0.2 percent vs. 0.3 percent), pneumonia (0.2 percent vs. 0.2 percent), fever (0.1 percent vs. 0.1 percent), and urinary tract infection (0.1 percent vs. 0.1 percent).
In a subset of more than 11,000 infants in these trials, the presence of adverse events was reported for 42 days after each dose. Fever was observed at similar rates in vaccine and placebo recipients (42.6 percent vs. 42.8 percent). Adverse events that occurred at a statistically higher incidence within 42 days of any dose among recipients of ROTATEQ as compared with placebo recipients were diarrhea (24.1 percent vs. 21.3 percent), vomiting (15.2 percent vs. 13.6 percent), otitis media (14.5 percent vs. 13.0 percent), nasopharyngitis (6.9 percent vs. 5.8 percent), and bronchospasm (1.1 percent vs. 0.7 percent).
In post-marketing experience, cases of intussusception have been reported in temporal association with ROTATEQ.
As with any vaccine, vaccination with ROTATEQ may not result in complete protection in all recipients.
The first dose of ROTATEQ should be administered between six and 12 weeks of age, with the subsequent doses administered at four- to 10-week intervals. The third dose should not be given after 32 weeks of age. ROTATEQ was approved by the FDA on February 3, 2006.
Through June 2007, Merck has distributed more than six million doses of ROTATEQ. ROTATEQ has been approved in more than 60 countries around the world.
Select safety and additional information about GARDASIL
GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine.
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.
Vaccination with 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, VIN, or VaIN. GARDASIL has not been shown to protect against disease due to other HPV types.
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 (83.9 percent vs. 75.4 percent), swelling (25.4 percent vs. 15.8 percent), erythema (24.6 percent vs. 18.4 percent), fever (10.3 percent vs. 8.6 percent), nausea (4.2 percent vs. 4.1 percent), pruritis (3.1 percent vs. 2.8 percent) and dizziness (2.8 percent vs. 2.6 percent).
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 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. GARDASIL (sold in some countries as SILGARD®) has been approved in 80 countries, including the United States, the 27 countries of the European Union, Mexico, Australia, Taiwan, Canada, New Zealand and Brazil, and additional applications are currently under review with regulatory agencies in many more countries around the world. Through the first quarter of 2007, Merck distributed five million doses of GARDASIL.
Other Information about GARDASIL
In 1995, Merck entered into a license agreement and research collaboration with CSL Limited of Australia relating to technology used in GARDASIL. GARDASIL also is the subject of other third-party licensing agreements.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com
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