title: Manufacturing costs of HPV vaccines for developing countries.
abstract: Nearly all of the 500,000 new cases of cervical cancer and 270,000 deaths occur in middle or lower income countries. Yet the two most prevalent HPV vaccines are unaffordable to most. Even prices to Gavi, the Vaccine Alliance, are unaffordable to graduating countries, once they lose Gavi subsidies. Merck and Glaxosmithkline (GSK) claim their prices to Gavi equal their manufacturing costs; but these costs remain undisclosed. We undertook this investigation to estimate those costs.
  
  
  
  Searches in published and commercial literature for information about the manufacturing of these vaccines. Interviews with experts in vaccine manufacturing.
  
  
  
  This detailed sensitivity analysis, based on the best available evidence, finds that after a first set of batches for affluent markets, manufacturing costs of Gardasil for developing countries range between $0.48 and $0.59 a dose, a fraction of its alleged costs of $4.50. Because volume of Cervarix is low, its per unit costs are much higher, though at comparable volumes, its costs would be similar.
  
  
  
  Given the recovery of fixed and annual costs from sales in affluent markets, Merck's break-even price to Gavi could be $0.50-$0.60, not $4.50. These savings could support Gavi programs to strengthen delivery and increase coverage. Outside Gavi, prices to lower- and middle-income countries, with profit, could also be lowered and made available to millions more adolescents at risk. These estimates and their policy implications deserve further discussion.
authors: Department of Molecular Biology, Princeton University, Princeton, NJ 08544, USA. Electronic address: csclendi@gmail.com.
authors: Chaevia
authors: C
authors: Clendinen
authors: A.B. Yale School of Medicine, 333 Cedar St, New Haven, CT 06510, USA. Electronic address: yapei.zhang@yale.edu.
authors: Yapei
authors: Y
authors: Zhang
authors: School of Public Administration, University of Victoria, Victoria, BC V8W 2Y2, Canada. Electronic address: rnwarbur@uvic.ca.
authors: Rebecca N
authors: RN
authors: Warburton
authors: Department of Psychiatry, Rowan University School of Osteopathic Medicine, 2250 Chapel Avenue, Cherry Hill, NJ 08002, USA. Electronic address: lightdo@rowan.edu.
authors: Donald W
authors: DW
authors: Light
mesh_terms: D000293:Adolescent; D003365:Costs and Cost Analysis; D003906:Developing Countries; D005260:Female; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 / Q000191:economics*; D006801:Humans; D000072499:Manufacturing and Industrial Facilities / Q000191:economics; D053918:Papillomavirus Vaccines / Q000191:economics*; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control; D014611:Vaccination
chemical_list: D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines; C510352:human papillomavirus vaccine, L1 type 16, 18
keywords: Access; Affordability; Gavi; Human papillomavirus; Manufacturing cost; Vaccine