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20-September-2008 09:55:52 - conjugate vaccine Pneumococcal conjugate vaccine or Prevnar is a vaccine used to protect infants and young children against disease caused by the bacterium Streptococcus pneumoniae pneumococcus. Prevnar is a heptavalent vaccine, meaning that it contains the cell membrane sugars of seven serotypes of pneumococcus, conjugated with Diphtheria proteins. It is manufactured by Wyeth as the brand name Prevnar.1 In the United States, vaccination with Prevnar is recommended for all children younger than 2 years, and for unvaccinated children between 24 and 59 months old who are at high risk for pneumococcal infections.2 Contents 1 Production technique 2 Centers for Disease Control recommendation 3 Efficacy 4 Evidence supporting addition to routine vaccination schedules 5 Clinical study 6 Vaccination in the Developing World 7 Sales 8 Controversy 9 References and notes 10 External links Production technique Prevnar is produced from the seven most prevalent strains of Streptococcus pneumoniae bacteria. The bacterial capsule sugars, a characteristic of these pathogens, are linked to CRM197, a nontoxic recombinant variant of diphtheria toxin Corynebacterium diphtheriae. The vaccine's polysaccharide sugars are grown separately in soy peptone broths. Through reductive amination, the sugars are directly conjugated to the protein carrier CRM197 to form the glycoconjugate. CRM197 is grown in Corynebacterium diphtheriae strain C7 in a medium of casamino acids and yeast extracts.1 The current 7-valent formulation contains serotypes 4,6B,9V,14,18C,19F, and 23F, and results in a 98% probability of protection against these strains, which caused 80% of the pneumococcal disease in infants. In 2009, Wyeth will be introducing Prevnar 13 which will contain six additional strains i.e., 1, 3, 5, 6A, 19A and 7F, which will protect children against the majority of the remaining pneumococcal infections. Centers for Disease Control recommendation In 2001, the Centers for Disease Control CDC, upon advice from its Advisory Committee on Immunization Practices, recommended the vaccine be administered to every infant and young child in the US. The resulting demand outstripped production, creating shortages not resolved until 2004. All children, according to current US vaccination schedules, should receive four doses, at two, four, six, and again between twelve and fifteen months of age. Efficacy Prevnar is designed to stop seven of about ninety bacteria which cause invasive pneumococcal disease. Each year, IPD kills approximately one million children worldwide.2 Since approval, Prevnar's efficacy in preventing invasive pneumococcal disease has been documented by a number of epidemiologic studies.345 The vaccine is however, primarily developed for the U.S. and European epidemiological situation, and therefore it has only a limited coverage of serotypes causing serious pneumococcal infections in most developing countries.6 Evidence supporting addition to routine vaccination schedules After introduction of the pneumococcal conjugate vaccine in 2000, several studies described a decrease in invasive pneumococcal disease in the United States. One year after its introduction, a group of investigators found a 69% drop in the rate of invasive disease in those age less than 2 years of age.7 By 2004, all-cause pneumonia admission rates had declined by 39% 95% CI 22-52 and rates of hospitalizations for pneumococcal meningitis decreased by 66% 95% CI 56.3-73.5 in children younger than 2. 8 9 Interestingly, rates of invasive pneumococcal disease among adults has also declined since the introduction of the vaccine.10 11 Although, it is more difficult to specifically attribute this decline in adults to the childhood pneumococcal conjugate vaccine since the adult pneumococcal 23-valent polysaccharide vaccine is also available. While an overall decline in invasive pneumococcal disease is well documented, concerns have been raised regarding a potential increase in the rate of infections caused by serotypes not covered in the vaccine. Recent data suggest that serotype replacement is increasing 1.61- and 1.28-fold increase in children and adults but remains minimal when compared to the significant reduction observed in the burden of this vaccine-preventable disease.12 Clinical study Prevnar was administered to nearly 20,000 children prior to licensure, and the side effects were evaluated. Rashes at the site of injection were noted in about one percent of children. Vaccination in the Developing World Pneumococcal disease is the leading vaccine-preventable killer of young children worldwide, according to the World Health Organization WHO, killing over 800,000 and up to a million children a year. Ninety percent of these deaths occur in the developing world.13 Historically 15-20 years pass before a new vaccine reaches one quarter of the population of the developing world.14 Pneumococcal vaccines Accelerated Development and Introduction Plan PneumoADIP is a GAVI Alliance GAVI funded project to accelerate the introduction of pneumococcal vaccinations into the developing world through partnerships between countries, donors, academia, international organizations and industry. With action now, a projected 5.4 million child deaths can be prevented by 2030. In May 2007, 30 of the 72 GAVI countries expressed interest in introducing pneumococcal conjugate vaccine between 2008 and 2010. These countries are Benin, Burundi, the Republic of Congo, Rep. of Cote d'Ivoire, Djibouti, the Democratic Republic of Congo, Ethiopia, Ghana, Guyana, Honduras, Indonesia, Kenya, Madagascar, Malawi, Mali, Mongolia, Nicaragua, Pakistan, Rwanda, Sao Tome and Principe, Senegal, Solomon Islands, Sri Lanka, Sudan, The Gambia, Timor Leste, Togo, Uganda, Yemen, and Zambia.15 Sales Prevnar is among Wyeth's top revenue producers, with sales in 2005 of $1.5 billion, up 43 percent from 2004.Wyeth Annual report Controversy Controversy has arisen regarding pneumococcal vaccine advertisements aired by Wyeth in Poland and Saudi Arabia. A television commercial for Prevnar, showing a dying child and its mother, was banned in Poland by the main pharmaceutical inspector GIF, Zofia Ulz, on April 3, 2007. According to Ulz, the ad was designed to provoke fear to attract customers. Wyeth responded by asserting the tactic was used to increase awareness of the potential danger represented by pneumococcal infections.16 In addition, Wyeth has been accused of conflict of interest in economic evaluations of Prevnar.17 The selling price of conjugate vaccines is clearly very high 18 19. The WHO, pneumo ADIP and other associations are taking steps to make cheaper, more effective vaccines available with partners in countries such as India, and Brazil.citation needed References and notes ^ Pneumococcal 7-valent Conjugate Vaccine Diphtheria CRM197 Protein. Wyeth 2006. ^ American Academy of Pediatrics. Committee on Infectious Diseases. Policy statement: recommendations for the prevention of pneumococcal infections, including the use of pneumococcal conjugate vaccine Prevnar, pneumococcal polysaccharide vaccine, and antibiotic prophylaxis 2000. Pediatrics 106 2 Pt 1: 362-6. PMID 10920169. ^ Whitney CG, Farley MM, Hadler J, Harrison LH, Bennett NM, Lynfield R, Reingold A, Cieslak PR, Pilishvili T, Jackson D, Facklam RR, Jorgensen JH, Schuchat A; Active Bacterial Core Surveillance of the Emerging Infections Program Network. Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine. N Engl J Med. 2003 May 1;34818:1737-46. PMID 12724479. ^ Poehling K, Talbot T, Griffin M, Craig A, Whitney C, Zell E, Lexau C, Thomas A, Harrison L, Reingold A, Hadler J, Farley M, Anderson B, Schaffner W 2006. Invasive pneumococcal disease among infants before and after introduction of pneumococcal conjugate vaccine. JAMA 295 14: 1668-74. doi:10.1001/jama.295.14.1668. PMID 16609088. ^ Whitney C, Pilishvili T, Farley M, Schaffner W, Craig A, Lynfield R, Nyquist A, Gershman K, Vazquez M, Bennett N, Reingold A, Thomas A, Glode M, Zell E, Jorgensen J, Beall B, Schuchat A 2006. Effectiveness of seven-valent pneumococcal conjugate vaccine against invasive pneumococcal disease: a matched case-control study. Lancet 368 9546: 1495-502. doi:10.1016/S0140-67360669637-2. PMID 17071283. ^ Barocchi MA, Censini S, Rappuoli R 2007. Vaccines in the era of genomics: the pneumococcal challenge. Vaccine 25 16: 2963-73. doi:10.1016/j.vaccine.2007.01.065. PMID 17324490. ^ Whitney CG, et al. N Engl J Med 2003;34818:1737-46 ^ Grijalva C, et al. Lancet 2007;3699568:1179-86 ^ Tsai CJ, et al. Clin Infect Dis 2008;46:1664-72 ^ Whitney CG, et al. N Engl J Med 2003;34818:1737-46 ^ Tsai CJ, et al. Clin Infect Dis 2008;46:1664-72 ^ Albrich WC, et al. Clin Infect Dis 2007;44:1569-76 ^ WHO 1999. Pneumococcal vaccines. WHO position paper. Wkly. Epidemiol. Rec. 74 23: 177-83. PMID 10437429. ^ PneumoADIP | Need for PneumoADIP ^ PneumoADIP | Vaccine Introduction ^ Controversial pneumococcal vaccine ad - Polish Market News. Retrieved on 2008-02-20. ^ Beutels P 2004. Potential conflicts of interest in vaccine economics research: a commentary with a case study of pneumococcal conjugate vaccination. Vaccine 22 25-26: 3312-22. doi:10.1016/j.vaccine.2004.03.001. PMID 15308354. ^ Barocchi MA et al., Vaccine 25 2007 2963-2973. Vaccines in the era of genomics: the pneumococcal challenge ^ Beall B, Vaccination with the pneumococcal 7-valaent conjugate: a successful experiment but the species is adapting. Expert Reviews Vaccines 63 297-301, 2007. Black S, Shinefield H, Fireman B, Lewis E, Ray P, Hansen J, Elvin L, Ensor K, Hackell J, Siber G, Malinoski F, Madore D, Chang I, Kohberger R, Watson W, Austrian R, Edwards K Mar 2000. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Northern California Kaiser Permanente Vaccine Study Center Group.. Pediatr Infect Dis J 19 3: 187-95. PMID 10749457. with followup paper: Black S, Shinefield H Dec 2002. Safety and efficacy of the seven-valent pneumococcal conjugate vaccine: evidence from Northern California.. Eur J Pediatr 161 Suppl 2: S127-31. doi:10.1007/s00431-002-1064-z. PMID 12494258. Lieu T, Ray G, Black S, Butler J, Klein J, Breiman R, Miller M, Shinefield H Mar 15 2000. Projected cost-effectiveness of pneumococcal conjugate vaccination of healthy infants and young children.. JAMA 283 11: 1460-8. doi:10.1001/jama.283.11.1460. PMID 10732936. Shinefield H, Black S, Ray P, Chang I, Lewis N, Fireman B, Hackell J, Paradiso P, Siber G, Kohberger R, Madore D, Malinowski F, Kimura A, Le C, Landaw I, Aguilar J, Hansen J Sep 1999. Safety and immunogenicity of heptavalent pneumococcal CRM197 conjugate vaccine in infants and toddlers.. Pediatr Infect Dis J 18 9: 757-63. doi:10.1097/00006454-199909000-00004. PMID 10493334. Shinefield H, Black S Apr 2000. Efficacy of pneumococcal conjugate vaccines in large scale field trials.. Pediatr Infect Dis J 19 4: 394-7. doi:10.1097/00006454-200004000-00036. PMID 10783042. External links Wyeth.com - Official Wyeth website ArabNews.com - 'Pharmaceutical Ads Scare Parents', Lulwa Shalhoub, Arab News July 4, 2007 Vaccine tied to superbug ear infection, Marilynn Marchione, Associated Press September 17, 2007 NVIC - Statement about Prevnar from the National Vaccine Information Center PneumoADIP - Pneumococcal vaccines Accelerated Development and Introduction Plan v d e Vaccines, Vaccination, Immunization, and Inoculation see also artificial induction of immunity Development Adjuvants Cancer vaccines DNA vaccination HIV Live vector vaccine Models Timeline Trial Administration Global: GAVI Policy Schedule Vaccine injury USA: ACIP VAERS VSD Vaccine court Vaccines live Anthrax BCG tuberculosis Flu MMR MMRV PolioOPV Rotavirus Smallpox Varicella Yellow fever Inactivated/toxoid inactivated virus: Flu HAV PolioIPV inactivated bacteria/toxoid: DTwP conjugate: Hib PCV Other subunit: Anthrax DTaP HPV recombinant DNA: HBV other: Anthrax PPV Controversy General A-CHAMP MMR NCVIA Pox party Safe Minds Thiomersal See also List of vaccine topics Epidemiology Eradication of infectious diseases Retrieved from http://en..org/wiki/Pneumococcal_conjugate_vaccine Categories: VaccinesHidden categories: All articles with statements | Articles with statements since February 2008 Views Article Discussion this page History Personal tools Log in / create account Navigation Main page Contents Featured content Current events Random article Search Go Search Interaction Community portal Recent changes Contact Donate to Help Toolbox What links here Related changes Upload file Special pages Printable version Permanent link Cite this page This page was last modified on 9 July 2008, at 17:27
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