About
- Merial = Merger of Merck & Co. Inc. (MSD AgVet) and Sanofi-Aventis (Rhone Mérieux) in 1997. In 2009, Merck sells its 50% to Sanofi-Aventis for $4 billion in cash.
- 2009: Merger of Merck & Co. Inc. (68%) and Schering-Plough (32%) for 41.1 billion dollar deal by 56% stock and 44% cash financed with $9.8 billion from existing cash balances and $8.5 billion from committed financing provided by J.P. Morgan.
- 2010: Equally-owned Joint Venture with Sanofi-Aventis by combining Merial (entreprise value fixed at $8 billion) with Intervet/Schering-Plough (entreprise value fixed at $8.5 billion), leading to true-up payment of $250 million to Merck to establish a 50/50 joint venture, and an additional $750 million.
- Supports the United Nations Global Compact.
- Component of the Dow Jones Industrial Average.
- Member of The Corporate Council on Africa.
- Corporate member of the Council on Foreign Relations.
Business
1891-2006
- 1891: Established in the United States as subsidiary of German company Merck KGaA.
- 1917: Confiscated during World War I and set up as independent company.
- 1940: Max Tishler develops sulfaquinoxaline, first efficient anticoccidial for use in the poultry industry.
- 1960: Launch of first avian veterinary products, Nicrazin and Amprol.
- 1962: Launch of Thibenzole (thiabendazole), first broad-spectrum endoparasitic agent.
- 1974: Acquisition of Hubbard (acquired by Groupe Grimaud in 2005).
- 1978: Acquisition of British United Turkeys.
- 1979: Creation of Merck MSD AgVet, including all animal health and poultry breeding activities and all crop science activities.
- 1980: Development of 19 different forms of ivermectin for the treatment of more than 11 animal species against internal and external parasites.
- 1986: HIV research program begins.
- 1987: MECTIZAN Donation Program begins.
- 1996: Merck AgVet ranks Nº2 on the world animal health market.
- 2006: Acquisition of Sirna Therapeutics Inc., original Ribozyme Pharmaceutical, co-founded in 1993 by Thomas R. Cech, president of Howard Hughes Medical Institute, and elected for the board of directors of Merck in May 2009.
2007
- License and Research Collaboration Agreement with SurModics Inc. to pursue joint development and commercialization of I-vation sustained drug delivery system with Triamcinolone Acetonide and other products that combine Merck proprietary drug compounds with the I-vation system for the treatment of serious retinal diseases.
- Global collaboration with ARIAD Pharmaceuticals Inc. to jointly develop and commercialize AP23573, ARIAD's novel mTOR inhibitor, for use in cancer.
- Acquisition of NovaCardia Inc., privately held clinical-stage pharmaceutical company focused on cardiovascular diseases. NovaCardia's investors include Domain Associates, Forward Ventures, Montreux Equity Partners, Versant Ventures, Skyline Ventures and InterWest Partners. NovaCardia spins-out new corporate entity to support clinical development of the company's second compound, K201 (JTV-519) for atrial fibrillation.
- Partnership with GlaxoSmithKline for over-the-counter marketing rights for MEVACOR.
2008
- The Merck Company Foundation creates the Merck Alliance to Reduce Disparities in Diabetes.
- Merck BioVentures, new division which capitalizes on the manufacture of biologics, as well as proprietary technologies that streamline the production of protein-based therapies.
- More than $8 million in grants to more than 200 non-governmental organizations and community-based organizations to combat HIV and AIDS in the U.S. and worldwide.
2009
- Definitive agreement with Insmed Inc. to purchase portfolio of follow-on biologic therapeutic candidates and its commercial manufacturing facilities located in Boulder, Colo.
- Licensing agreement with Medicines for Malaria Venture for an investigational drug candidate for the treatment of malaria in the developing world.
- Worldwide licensing agreement with Santen Pharmaceutical Co. Ltd. for Tafluprost, approved in several European and Nordic countries, Japan and Asia Pacific markets for the reduction of elevated intraocular pressure in open-angle glaucoma and ocular hypertension.
- Collaboration and license agreement with Cardiome Pharma Corp. for the development and commercialization of vernakalant, an investigational candidate for the treatment of atrial fibrillation.
- Collaboration with AstraZeneca to investigate novel combination anticancer regimen.
- Worldwide license agreement with Portola Pharmaceuticals Inc. to develop and commercialize Betrixaban, a novel investigational oral anticoagulant for cardiovascular disease.
- Master agreement with Drugs for Neglected Diseases initiative to support discovery and development of improved treatments for neglected tropical diseases.
- Exclusive agreement with CSL Biotherapies, subsidiary of CSL Limited, to market and distribute AFLURIA (Influenza Virus Vaccine).
- Merck Sharp & Dohme (Holdings) Limited (MSD, Merck affiliate) acquires biologics business of Avecia Investments Limited, contract manufacturing organization with specific expertise in microbial-derived biologics.
2010
- Merck's MECTIZAN Donation Program announces $150,000 donation to The Carter Center for post-treatment surveillance in areas where the transmission of river blindness has been interrupted to confirm treatment with MECTIZAN is no longer necessary. The World Health Organization requires 3 years of surveillance before certifying that a country has officially eliminated river blindness. The MECTIZAN Donation Program reaches more than 100 million people annually. In Latin America, since 1989, more than 9.6 million treatments delivered by community health workers and non-governmental organizations. Treatment programs currently exist in Brazil, Guatemala, Mexico and Venezuela.
- The Merck Company Foundation announces a round of 30 "Neighbor of Choice" grants (totaling $809,000) to organizations throughout New Jersey.
- Intervet/Schering-Plough Animal Health announces new partnership with the National Education for Assistance Dog Services, national nonprofit organization that trains dogs to serve individuals who are deaf or physically disabled.
- Eli Lilly and Company, Merck and Pfizer Inc. forms Asian Cancer Research Group Inc., company established to accelerate research in the most commonly-diagnosed cancers in Asia. Over the next 2 years commitment to create one of the most extensive pharmacogenomic cancer databases known to date, composed of data from approximately 2,000 tissue samples from patients with lung and gastric cancer.
- Launch of the Merck Oncology Collaborative Trials Network, pioneering clinical trial network focusing on the development of drug and vaccine candidates being investigated for the treatment and prevention of cancer.
- Merck and Codexis Inc. jointly awarded annual Presidential Green Chemistry Challenge Award from the U.S. Environmental Protection Agency for the development of a novel biocatalytic method for the synthesis of sitagliptin.
- UNCF/Merck Science Initiative, partnership with the United Negro College Fund, announces award scholarships and fellowships to 37 African American students in the biological and chemical sciences.
- Signing of statement of mutual intent with Sinopharm (China National Pharmaceutical Group Corporation) to cooperate on HPV vaccine and other mutually-selected vaccine products in China, and discuss the potential for promoting and marketing Merck's pharmaceutical products in China.
- Non-exclusive license agreement with Laboratory Corporation of America Holdings for commercialization of genetic test that may help predict the response of patients with Hepatitis C virus infection to peginterferon alpha-based therapy.
- Partnership with Black AIDS Institute launches Dynamic National HIV/AIDS Treatment and Care Advocacy Network. Black Treatment Advocates Network focuses on black americans in the U.S.
- Partnership with Sesame Workshop, nonprofit educational organization behind Sesame Street, to develop "Food for Thought: Eating Well on a Budget", bilingual education outreach program aimed at helping low-income families make food choices that are affordable, nutritional and set the foundation for lifelong healthy habits.
- The Merck Company Foundation and the Bill & Melinda Gates Foundation commit additional $60 million to support Botswana's African Comprehensive HIV/AIDS Partnerships, unique program developed with and led by the Government of Botswana. Total cash contributions amount to $166.5 million. Merck also continues donation of HIV medicines, created by initial investment of $56.5 million (2001), will contribute an additional $30 million over the next 5 years.
- Newark Public Schools and the Merck Institute for Science Education enter partnership to reform science education in state's largest school district, joining president Obama's "Educate to Innovate" campaign.
- Innovative collaboration with Weight Watchers International Inc., world's leading provider of weight management services, focused on fighting obesity. Merck provides physicians and other health care providers with educational information about the Weight Watchers program and its underlying clinical evidence to assist doctors in addressing the ongoing weight management needs of their patients.
- Acquisition of SmartCells, private company developing glucose responsive insulin formulation for the treatment of diabetes mellitus.
- Collaboration with The PATH Malaria Vaccine Initiative and NYU Langone Medical Center to research potential malaria vaccine.
Products
2007
- ISENTRESS, first-in-class HIV integrase inhibitor for use in combination with other antiretroviral agents for treatment of HIV-1 infection in treatment-experienced adult patients, launched in the United States, European Union, Canada and Mexico.
- Merck, the HIV Vaccine Trials Network and the National Institutes of Health announce that HIV vaccine created by Merck Research Laboratories in development for more than a decade is not effective.
2008
- IVEMEND approved in the European Union.
- FDA approves use of EMEND for injection (IVEMEND in E.U.), an intravenous therapy for chemotherapy-induced nausea and vomiting, and ISENTRESS (raltegravir), Merck's first-in-class HIV integrase inhibitor.
- TREDAPTIVE (nicotinic acid/laropiprant) 1 g/20 mg modified-release tablets, new lipid-modifying therapy for patients with dyslipidemia and primary hypercholesterolemia, approved in the European Union, Iceland and Norway.
- ROTATEQ receives WHO prequalification for use in Europe and Latin America. Vaccine eligible for procurement by UNICEF and other United Nations agencies, including the Pan American Health Organization, for use in national vaccination programs.
2009
- FDA approves ZEGERID OTC (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules) for over-the-counter treatment of frequent heartburn, marketed over-the-counter by Schering-Plough HealthCare Products Inc., consumer healthcare division of Merck & Co. Inc.
- FDA approval of SAPHRIS for the acute treatment of schizophrenia in adults and as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults.
- FDA approves expanded indication for ISENTRESS to include the treatment of adult patients starting HIV-1 therapy for the first time, as well as treatment-experienced adult patients, in combination with other antiretroviral medicines.
2010
- Schering-Plough Consumer HealthCare and the maker of non-drowsy CLARITIN allergy medicines partners with Kara Dioguardi, judge on TV's hottest show, to collect inspirational stories from allergy sufferers across america.
- Agreement with MassBiologics of the University of Massachusetts Medical School that provides exclusive rights to market and distribute tetanus and diphtheria toxoids adsorbed vaccine in the U.S., with the exception of Massachusetts. Merck's Adult Vaccine Portfolio includes 9 of the 10 Vaccines on the U.S. CDC's Recommended Adult Immunization Schedule.
- Co-promotion agreement for Canada and certain European countries with Nycomed for the commercialization of Daxas (roflumilast), investigational once-daily tablet for patients with chronic obstructive pulmonary disease, and exclusive distribution agreement for commercialization in the UK.
- Restructured co-development and co-commercialization agreement with ARIAD Pharmaceuticals Inc. to exclusive license agreement for ridaforolimus, investigational orally available mTOR inhibitor. Merck acquires full control of the development and worldwide commercialization of ridaforolimus. ARIAD receives $50 million upfront fee and is eligible to receive milestone payments associated with regulatory filings and approvals of ridaforolimus in multiple cancer indications and achievement of significant sales thresholds. In lieu of the profit split on U.S. sales provided for in the previous agreement, ARIAD receives royalties on global net sales of ridaforolimus, and all sales are booked by Merck. Merck assumes responsibility for all activities and has acquired decision rights on matters relating to the development, manufacturing and commercialization of ridaforolimus. The Investigational New Drug application is transferred to Merck, and Merck files the marketing application worldwide for any oncology indications and leads all interactions with regulatory agencies.
- Merck and the ADAP Crisis Task Force announce key initiatives to help provide funding relief to AIDS Drug Assistance Programs across the U.S.
- European Commission approval of ELONVA (corifollitropin alfa injection), indicated for controlled ovarian stimulation in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology program.
- ROTATEQ (Rotavirus Vaccine, Live, Oral, Pentavalent), vaccine for infants and children, receives extension of prequalification status by the World Health Organization, to include its use in Asia and Africa. Vaccine eligible for procurement by UNICEF and other United Nations agencies, including the Pan American Health Organization, for use in national vaccination programs.
- ZEGERID OTC (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules), new over-the-counter option for treating frequent heartburn without a prescription, becomes available in drug stores, grocery stores, mass merchandisers and club stores in U.S.
- GlaxoSmithKline and Merck announce FDA approval of STAXYN (vardenafil HCI), orally disintegrating tablet indicated for the treatment of erectile dysfunction.
- Strategic collaboration with Adcock Ingram, publicly held South African company, to co-promote and distribute products in South Africa.
- FDA approves DULERA (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, new fixed-dose combination asthma treatment for patients 12 years of age and older. Not indicated for relief of acute bronchospasm.
- FDA approves new labeling for ISENTRESS (raltegravir) to Include 96-Week efficacy and tolerability data in adult patients infected with HIV-1.
- Merck and Cardiome Pharma Corp. announce marketing approval for the intravenous formulation of BRINAVESS (vernakalant) in the European Union, Iceland and Norway for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults, for non-surgery patients (7 days or less) and for post-cardiac surgery patients (3 days or less).
- FDA approval for expanded indications for atypical antipsychotic medication SAPHRIS (asenapine) Sublingual Tablets, indicated for the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
- Expansion of medicines available through Merck Helps patient assistance programs, which include the Merck Patient Assistance Program, the Merck Vaccine Patient Assistance Program, the ACT Program for Oncology and Hepatitis C medicines, and the SUPPORT Program for HIV/AIDS medicines.
- ROTATEQ (Rotavirus Vaccine, Live, Oral, Pentavalent), vaccine for rotavirus gastroenteritis in infants and children, received the Prix Galien USA 2010 Award for Best Biotechnology Product.
- SYCREST receives approval from the European Medicines Agency for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.
- Exclusive commercialization agreement with Lundbeck for SYCREST (asenapine) Sublingual Tablets in all markets outside of the United States, China and Japan.
- Expanded co-pay assistance program for ISENTRESS (raltegravir) first-in-class HIV-1 integrase inhibitor.
Financial Results
2008
- Worldwide sales: $23.9 billion.
- Net income: $7,808.4 million.
- Equity income from affiliates: $2.6 billion.
- Materials and production costs: $5.6 billion.
- Marketing and administrative expenses: $7.4 billion.
- Research and development expenses: $4.8 billion.
- Global restructuring programs: $1.3 billion.
2007
- Net income: $3,275.4 million.
- Materials and production costs: $6.1 billion.
- Marketing and administrative expenses: $7.6 billion.
- Research and development expenses: $4.9 billion.
- Global restructuring programs: $810 million.
2006
- Worldwide sales: $22.6 billion.
- Net income: $4,433.8 million.
- Materials and production costs: $6.0 billion.
- Marketing and administrative expenses: $8.2 billion.
- Research and development expenses: $4.8 billion.
Product Performance Highlights
2008 Sales
- JANUVIA (sitagliptin), first-in-class DPP-4 inhibitor for the treatment of type 2 diabetes: $1.4 billion.
- JANUMET (sitagliptin/metformin hydrochloride), single tablet that targets all three key defects of type 2 diabetes: $351 million.
- ISENTRESS (raltegravir): $361 million.
- SINGULAIR (montelukast sodium), once-a-day oral medicine for chronic treatment of asthma and symptoms of allergic rhinitis: $4.3 billion.
- COZAAR (losartan potassium) and HYZAAR (losartan potassium and hydrochlorothiazide), antihypertensive medicines: $3.6 billion.
- ZOSTAVAX, vaccine to help prevent shingles (herpes zoster): $312 million.
- ROTATEQ (rotavirus vaccine, live, oral, pentavalent), rotavirus gastroenteritis vaccine for children: $665 million.
- VARIVAX (varicella virus vaccine live), M-M-R II (measles, mumps and rubella virus vaccine live) and PROQUAD (measles, mumps, rubella and varicella virus vaccine live): $1.3 billion.
2007 Sales
- SINGULAIR, once-a-day oral medicine for chronic treatment of asthma and symptoms of allergic rhinitis: $4.3 billion. (Nº1 prescribed product in the U.S. respiratory market).
- COZAAR and HYZAAR, antihypertensive medicines: $3.4 billion.
- FOSAMAX and FOSAMAX PLUS D (FOSAVANCE throughout the E.U.): $3.0 billion.
- ROTATEQ: $525 million.
- VARIVAX, PROQUAD and M-M-R II, pediatric vaccines: $1.3 billion.
- VARIVAX, chickenpox vaccine: $855 million.
- ZOSTAVAX: $236 million.
History
- Merck knows Vioxx raises the risk of heart-related side effects by 35%.
- 1999: FDA approval to treat osteoarthritis, acute pain conditions, and dysmenorrhoea; Killed up to 140,000 people after being 'proved safe' in animals, including monkeys.
- 2000: Enero, llega al mercado español; Marzo, ensayo clínico patrocinado por Merck (compara Vioxx con un antiinflamatorio clásico en 8000 pacientes) desvela que quienes toman el primero tienen menos problemas gastrointestinales pero 4 veces más riesgo cardiovascular.
- 2001: Agosto, extensa revisión en la revista "JAMA" pone en entredicho la seguridad cardiovascular de los COX-2; Septiembre, la FDA amonesta a Merck por no advertir en la publicidad dirigida a los médicos del riesgo coronario.
- 2002: Abril, la FDA ordena que se modifique el etiquetado de Vioxx, deberá incluir una advertencia sobre sus riesgos cardiovasculares; Julio, el Ministerio de Sanidad introduce la exigencia de visado para todas las recetas de inhibidores de la COX-2.
- 2004: Agosto, estudio realizado por la FDA dice que las personas que consumen la dosis más alta de rofecoxib triplican su riesgo cardiaco; September, the FDA's decision to approve Vioxx for children is reached at the same time that Merck decide to withdraw the drug because it causes cardiac arrest and kills people. Los reumatólogos estadounidenses advierten que se valoren los riesgos cardiacos de los COX-2 antes de recetarlos.
- 2005: Merck is found liable in the first case that went to trial and the plaintiff was awarded $253.4 million in damages; however, the judgement was subsequently reduced to $20 million and then, upon appeal, the verdict was reversed in 2008.
- 2007: November, Merck proposed to pay $4.85 billion to settle most of the pending Vioxx lawsuits. The settlement will require that claimants provide medical proof of having suffered a heart attack or a stroke and show they received at least 30 Vioxx pills. This proposed settlement is generally viewed by industry analysts and investors as a victory for Merck, considering that original estimates of Merck's liability reached as high as $50 billion. As of mid-2008, plaintiffs have prevailed in only three of the twenty cases that have reached juries, all with relatively small awards.
- 2008: May 20, Merck is found liable for using deceptive marketing tactics to promote Vioxx and 30 states split the $58 million settlement, the largest multi-state settlement against a pharmaceutical company. All its new television pain-advertisements must be vetted by the FDA and changed or delayed upon request until 2018.
Scott S. Reuben
- Professor of Anesthesiology and Pain Medicine at Baystate Medical Center in Springfield, Massachusetts. Educated at Columbia University. Graduated from medical school at the State University of New York at Buffalo in 1985 and anesthesiology residency at Mount Sinai Medical Center in New York.
- 5 research grants (2002-2007) by Pfizer. Paid member of the company's speakers bureau, giving talks about Pfizer drugs to colleagues.
- March 11, 2009: Admits that fabricated much of the data underlying his research and never conducted the clinical trials that wrote about in 21 journal articles dating from at least 1996, in some cases, even invented the patients. Reported favorable results from painkillers including Pfizer's Bextra, Celebrex and Lyrica, Merck's Vioxx and Wyeth's antidepressant Effexor, and wrote to the FDA urging the agency not to restrict the use of many of the painkillers he studied, citing his own data on their safety and effectiveness.
Press
- Vioxx became one of the most prescribed drugs in history. Worldwide, over 80 million people were prescribed rofecoxib at some time. Sales revenue of $2.5 billion in 2003.
- Entre 1999 y 2004 se dispensaron en EEUU más de 100 millones de recetas de Vioxx.
- Merck had a list of doctors critical of Vioxx to be "neutralised" or "discredited". "We may need to seek them out and destroy them where they live", wrote an employee. Also alleged were intimidation of researchers and impingement upon academic freedom.
- En los años 90 (Vioxx aún no comercializado) empleados de la empresa intercambiaron correos electrónicos manifestando su preocupación por los riesgos cardiovasculares del fármaco.
- La alternativa de Pfizer se beneficia de la retirada de Vioxx.
- David J. Graham, M.D., M.P.H., Associate Director of the FDA's Office of Drug Safety: "I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless", (November 18, 2004).
2010
- The Royal Government of Bhutan (Her Majesty the Royal Grandmother Ashi Kesang Choeden Wangchuck and the Bhutan Ministry of Health), Merck and the Australian Cervical Cancer Foundation launch 6 year national vaccination program with GARDASIL (Human Papillomavirus Quadrivalent Types 6, 11, 16 and 18 Vaccine, Recombinant) for appropriate girls and young women between the ages of 12 and 18 in Bhutan.
- FDA approval of GARDASIL (Human Papillomavirus Quadrivalent Types 6, 11, 16, and 18 Vaccine, Recombinant) for the prevention of anal cancer caused by human papillomavirus types 16 and 18 and for the prevention of anal intraepithelial neoplasia grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16 and 18, in males and females 9 through 26 years of age.
2009
- February: 40 million doses distributed worldwide.
- Federal report conclude that the human papillomavirus vaccine Gardasil has a 400% higher rate of adverse effects than another comparable vaccine, the Menactra anti-meningitis shot. Associated with twice as many emergency room visits, 4 times as many deaths, 4 times as many heart attacks, 7 times as many "disabled" reports and 15 times as many strokes. All reported cases of blood clots and heart attacks associated with Gardasil occurred when the vaccine was given alone, not in conjunction with other drugs.
- First cervical cancer vaccine to receive WHO pre-qualification. Now eligible for procurement by the United Nations Children's Fund and other United Nations agencies including the Pan American Health Organization, for use in national immunization programs.
- FDA approves GARDASIL, Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine Recombinant, for use in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus types 6 and 11.
- U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices supports the permissive use of GARDASIL for boys and young men ages 9 to 26. Also recommens vaccination with either the bivalent or the quadrivalent HPV vaccine for the prevention of HPV 16 and -18 related cervical cancers, precancers and dysplastic lesions, and recommended vaccination with the quadrivalent HPV vaccine, GARDASIL, for the prevention of cervical, vulvar and vaginal cancers, precancers and dysplastic lesions due to HPV types 16 or 18, and for prevention of genital warts due to HPV types 6 or 11.
2008
- The European Medicines Agency reports: 2 young women died shortly after receiving Gardasil.
- 3 young women, aged 12, 19 and 22, died in the United States within days after receiving a Gardasil shot. 1,700 cases reported of patients suffering non-lethal adverse reactions.
- 3 girls in Australia developed pancreatitis shortly after being given the Gardasil jab.
- U.S. Citizenship and Immigration Services announces that people from other countries who want to become legal permanent residents of the US are required to have the HPV vaccination to protect against cervical cancer.
2007
- 3,461 complaints filed with FDA's Vaccine Adverse Event Report System since its approval in 2006, and 11 women died after exposure to the vaccine.
- Side-effects reported included paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures. And of 42 women who were vaccinated with Gardasil while pregnant, 18 experienced complications, ranging from miscarriages to fetal abnormalities, according to FDA data. One of the 18 women was diagnosed with an abnormal fetus, and test conducted on another woman during her pregnancy showed increased risk of fetal defect.
- Sales: $1.5 billion.
2006
- Approval for 9 to 26 year old girls and women.
Gardasil Vaccine Injuries & Deaths