Biotechnology product - Prevnar

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Biotechnology product - Prevnar

  1. 1. By Omita Trivedi and Neha Gandhi 1
  2. 2. Biotechnology applies scientific disciplines including chemistry, engineering, physicsand computing to living organisms to create innovative products and techniques.Health Biotechnology is the largest sector of biotechnology that creates productsIncluding therapies and drugs, vaccines and new diagnostic and testing equipment.  Therapeutics – new biologic drugs include skin grown for burn victims, gene and stem cell therapies, new drugs and personalized medicine  Diagnostics –test kits for HIV, or diabetes provide new, lower cost, options to test for devastating diseases quickly and effectively  Medical Devices– biosensors, stents, prostheses  Vaccines - over 25 companies make innovative vaccines for childhood and adult diseases By Omita Trivedi and Neha Gandhi 2
  3. 3. Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Prevnar®,is a sterile solution of saccharides of the capsular antigens of Streptococcuspneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F individually conjugated todiphtheria CRM197 protein. At least 90 Capsular Serotypes are known based on the structural and chemical structure of the capsular polysaccharides By Omita Trivedi and Neha Gandhi 3
  4. 4. S. pneumoniae is an important cause of morbidity and mortality in persons of allages worldwide. The organism causes invasive infections, such as bacteremia andmeningitis, as well as pneumonia and upper respiratory tract infections includingotitis media and sinusitis. In children older than 1 month, S. pneumoniae is the mostcommon cause of invasive disease.Every year in Canada, over half a million cases of pneumococcal disease are reported ininfants and children, and thousands of Canadian children will undergo ear tube insertionto treat otitis media. The total annual treatment costs for pneumococcal disease amounts tonearly 200 million dollars a year. Increased resistance to penicillin and other important classes of antimicrobials hascomplicated the management of S. pneumoniae infections in recent years By Omita Trivedi and Neha Gandhi 4
  5. 5. People at increased risk• Children aged under two years• Children under five years with underlying medical conditions predisposing them to invasive pneumococcal disease• Indigenous children, especially in central Australia• People aged 65 years and over• People with weakened immune systems• People with chronic diseases such as diabetes, lung disease, cancer or kidney disease• People who have impaired spleen function or have had their spleen removed• Tobacco smokers. By Omita Trivedi and Neha Gandhi 5
  6. 6.  The immune response to most antigens is T-dependent and involves the collaboration of CD4+ T-cells and B-cells, recognizing the antigen in a linked fashion. CD4+ T-cells (T-helper cells) provide signals to B-cells directly through cell surface protein interactions, and indirectly through the release of cytokines. These signals result in proliferation and differentiation of the B-cells and production of high-affinity antibodies. This also facilitates generation of memory B-cells that rapidly mobilize and secrete antibodies upon re-exposure to the same antigen. By Omita Trivedi and Neha Gandhi 6
  7. 7.  Pneumococcal capsular polysaccharides (PSs), while varied in chemical structure, are T- independent antigens. In the absence of T-cell help, PS stimulated B-cells predominantly produce IgM antibodies; and no memory B-cells are generated. As vaccines, PSs are associated with poor or absent immunogenicity in infants less than 24 months of age and failure to induce immunological memory at any age. Conjugation of PSs to a protein carrier (CRM 197) overcomes the T-cell–independent nature of PS antigens. Protein carrier-specific T-cells provide the signals needed for maturation of the B-cell response and generation of B-cell memory. By Omita Trivedi and Neha Gandhi 7
  8. 8. Efficacy was assessed in a randomized, double-blinded clinical trial in aMultiethnic population at Northern California Kaiser Permanente (NCKP) fromOctober 1995 through August 20, 1998, in which 37,816 infants were randomized toreceive either Prevnar® or a control vaccine (an investigational meningococcalgroup C conjugate vaccine [MnCC]) at 2, 4, 6, and 12-15 months of age.Prevnar® was administered to 18,906 children and the control vaccine to 18,910children. By Omita Trivedi and Neha Gandhi 8
  9. 9. TABLE 1 Efficacy of Prevnar® Against Invasive Disease Due to S. pneumoniae in Cases Accrued From October 15, 1995 Through August 20, 1998 20,21 Prevnar® Control* Number of Cases Number of Cases Efficacy 95% CI Vaccine serotypes Per protocol 0 17 100% 75.4, 100 Intent-to-treat 0 22 100% 81.7, 100 All pneumococcal serotypes Per protocol 2 20 90.0% 58.3, 98.9 Intent-to-treat By Omita Trivedi and Neha Gandhi 9
  10. 10. Prevnar® is indicated for active immunization of infants and toddlers againstinvasive disease caused by S. pneumoniae due to capsular serotypes included inthe vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F).The routine schedule is 2, 4, 6, and 12-15 months of age.Prevnar® is also indicated for active immunization of infants and toddlers againstotitis media caused by serotypes included in the vaccine. However, for vaccineserotypes, protection against otitis media is expected to be substantially lower thanprotection against invasive disease. By Omita Trivedi and Neha Gandhi 10
  11. 11. Hypersensitivity to any component of the vaccine, including diphtheria toxoid, is acontraindication to use of this vaccine.This vaccine will not protect against s. pneumoniae disease caused by serotypes unrelatedto those in the vaccine, nor will it protect against other microorganisms that causeinvasive infections such as bacteremia and meningitis or non-invasive infections such asotitis media.This vaccine should not be given to infants or children with thrombocytopenia or anycoagulation disorder that would contraindicate intramuscular injection unless thepotential benefit clearly outweighs the risk of administration. If the decision is made toadminister this vaccine to children with coagulation disorders, it should be given withcaution.Immunization with Prevnar® does not substitute for routine diphtheria immunization. By Omita Trivedi and Neha Gandhi 11
  12. 12. Prevnar® is for intramuscular use only. Prevnar® SHOULD UNDER NOCIRCUMSTANCES BE ADMINISTERED INTRAVENOUSLY. The safety andimmunogenicity for other routes of administration (eg, subcutaneous) have notbeen evaluated.Fever, and rarely febrile seizure, have been reported in children receiving Prevnar®.Minor illnesses, such as a mild respiratory infection with or without low-gradefever, are not generally contraindications to vaccination. The administration ofPrevnar should be postponed in subjects suffering from acute severe febrile illness. By Omita Trivedi and Neha Gandhi 12
  13. 13. Children receiving therapy with immunosuppressive agents (large amounts ofcorticosteroids, antimetabolites, alkylating agents, cytotoxic agents) may notrespond optimally to active immunization.As with other intramuscular injections, Prevnar® should be given with caution tochildren on anticoagulant therapy.Simultaneous Administration with Other Vaccines:During clinical studies, Prevnar® was administered simultaneously with DTaP andHbOC, IPV, Hep B vaccines, MMR, and Varicella vaccine. Thus, the safetyexperience with Prevnar® reflects the use of this product as part of the routineimmunization schedule. By Omita Trivedi and Neha Gandhi 13
  14. 14. The majority of the safety experience with Prevnar® comes from the NCKP EfficacyTrial in which 17,066 infants received 55,352 doses of Prevnar®, along with otherRoutine childhood vaccines through April 1998Of the 17,066 subjects who received at least one dose of Prevnar® in the efficacytrial, there were: 24 hospitalizations (for 29 diagnoses) within 3 days of a dose from October 1995 through April 1998. 162 visits to the emergency room (for 182 diagnoses) within 3 days of a dose from October 1995 through April 1998. Urticaria-like rash was reported in 1.3%-6% of children in the period from 3 to 14 days following immunization, and was most often reported following the fourth dose when it was administered concurrently with MMR vaccine. One case of a hypotonic-hyporesponsive episode (HHE) was reported in the efficacy study following Prevnar® and concurrent DTP vaccines in the study period from October 1995 through April 1998. By Omita Trivedi and Neha Gandhi 14
  15. 15. In the Kaiser efficacy study in which 17,066 children received a total of 55,352Doses of Prevnar® and 17,080 children received a total of 55,387 doses of theControl vaccine (investigational meningococcal group C conjugate vaccine[MnCC]), seizures were reported in 8 Prevnar® recipients and 4 control vaccine recipients within 3 days of immunization from October 1995 through April 1998. twelve deaths (5 SIDS and 7 with clear alternative cause) occurred among subjects receiving Prevnar®, of which 11 (4 SIDS and 7 with clear alternative cause) occurred in the Kaiser efficacy study from October 1995 until April 20, 1999. By Omita Trivedi and Neha Gandhi 15
  16. 16. In addition to reports in clinical trials, the following adverse events have been reportedsince market introduction of Prevnar® worldwide. The following adverse events wereincluded based on strength of causal association, severity, or frequency of reporting forPrevnar®. Administration site conditions: injection site dermatitis, injection site urticaria, injection site pruritus Blood and lymphatic system disorders: lymphadenopathy localized to the region of the injection site Immune system disorders: hypersensitivity reaction including face edema, dyspnea, bronchospasm; anaphylactic/anaphylactoid reaction including shock Psychiatric disorders: crying Skin and subcutaneous tissue disorders: angioneurotic edema, erythema multiforme Respiratory: apnea By Omita Trivedi and Neha Gandhi 16
  17. 17. For intramuscular injection only. Not to be injected intravenously.The dose is 0.5 mL to be given intramuscularly.The vaccine should be injected intramuscularly. The preferred sites are the anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in toddlers and young children.The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel. By Omita Trivedi and Neha Gandhi 17
  18. 18. Vaccination schedule for infants and toddlersDose: Dose 1*† Dose 2† Dose 3† Dose 4‡Age at Dose: 2 months 4 months 6 months 12-15 months* Dose 1 may be given as early as 6 weeks of age.† The recommended dosing interval is 4 to 8 weeks.‡ The fourth dose should be administered at approximately 12-15 months of age,and at least 2 months after the third dose. By Omita Trivedi and Neha Gandhi 18
  19. 19. By Omita Trivedi and Neha Gandhi 19
  20. 20. Product Information Product Type – Vaccine Route of Administration - Intramuscular NDC Product Code (Source) – 0005-1970Marketing Information Marketing Category – BLA Application Number - BLA103905 Marketing Start Date - 03/01/2000Labeler Wyeth Pharmaceutical Division of Wyeth Holdings Corporation, a subsidiary of Pfizer Inc. (054065909)Establishment Name Wyeth Pharmaceutical Division of Wyeth Holdings Corporation, a subsidiary of Pfizer Inc. ID/FEI – 883534067 - Manufacture, Analysis, API Manufacture ID/FEI – 054065909 - Analysis, API Manufacture, Manufacture By Omita Trivedi and Neha Gandhi 20
  21. 21. The 6 additional serotypes are 1, 3, 5, 6A, 7F, and 19ALike Prevnar 7, Prevnar 13® does not provide 100% protection against vaccineserotypes or protect against nonvaccine serotypes. By Omita Trivedi and Neha Gandhi 21
  22. 22. Prevnar 13® builds upon the scientific foundation of Prevnar® 7 by providingcoverage against 6 additional serotypes that can cause IPD in young children.This includes serotype 19A, which is the leading cause of IPD in children lessthan 5 years of age and has become increasingly resistant to multipleantibiotics.Approved for use in children 6 weeks through 5 years of age and for adultsover 50 years of age.The vast majority of Health Care Providers have converted to Prevnar 13.Like Prevnar 7, Prevnar 13® does not provide 100% protection against vaccineserotypes or protect against nonvaccine serotypes. By Omita Trivedi and Neha Gandhi 22
  23. 23. • For infants and toddlers, Prevnar 13 is to be administered as a four-dose series at 2, 4, 6, and 12-15 months of age.• Children who have received one or more doses of Prevnar 7 may transition to Prevnar 13 to complete the four-dose immunization series.• Children 15 months to 5 years of age who have received four doses of Prevnar 7 may receive one dose of Prevnar 13 to elicit immune responses to the six additional serotypes. By Omita Trivedi and Neha Gandhi 23
  24. 24. Prevnar 13 is to be administered as a single dose of 0.5 mL to adults 50years and older including those previously vaccinated with apneumococcal polysaccharide vaccine.Overdose with Prevnar 13 is unlikely due to its presentation as a pre-filledsyringe.However, in infants and children there have been reports of overdose withPrevnar 13 defined as subsequent doses administered closer thanrecommended to the previous dose. In general, adverse eventsreported with overdose are consistent with those that have been reported withdoses given in the recommended pediatric schedules of Prevnar 13. By Omita Trivedi and Neha Gandhi 24
  25. 25. Product Information Product Type – Vaccine Route of Administration - Intramuscular NDC Product Code (Source) – 0005-1971Marketing Information Marketing Category – BLA Application Number – BLA125324 Marketing Start Date - 03/01/2010Labeler Wyeth Pharmaceutical Division of Wyeth Holdings Corporation, a subsidiary of Pfizer Inc. (054065909)Establishment Name Wyeth Pharmaceutical Division of Wyeth Holdings Corporation, a subsidiary of Pfizer Inc. ID/FEI – 883534067 – API Manufacture, Analysis, ID/FEI – 054065909 - Analysis, Manufacture By Omita Trivedi and Neha Gandhi 25
  26. 26. 1. http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7abf4185-109d-4e3c- 5da7-0b06589216372. http://www.biotech.ca/en/what-biotech-is/benefits.aspx3. http://www.pfizerpro.com/resources/salesrep_private/minisites/prevnar/docs/ PrevnarExitLetter.pdf4. Kim et al. Analytical Biochemistry Vol 347, Issue 2, Pages 262–2745. Pletz et. al. International Journal of Antimicrobial Agents, 2008 By Omita Trivedi and Neha Gandhi 26

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