1. By Omita Trivedi and Neha Gandhi 1

2. Biotechnology applies scientific disciplines including chemistry, engineering, physics
and computing to living organisms to create innovative products and techniques.
Health Biotechnology is the largest sector of biotechnology that creates products
Including 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
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3. Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Prevnar®,
is a sterile solution of saccharides of the capsular antigens of Streptococcus
pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F individually conjugated to
diphtheria 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
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4. S. pneumoniae is an important cause of morbidity and mortality in persons of all
ages worldwide. The organism causes invasive infections, such as bacteremia and
meningitis, as well as pneumonia and upper respiratory tract infections including
otitis media and sinusitis. In children older than 1 month, S. pneumoniae is the most
common cause of invasive disease.
Every year in Canada, over half a million cases of pneumococcal disease are reported in
infants and children, and thousands of Canadian children will undergo ear tube insertion
to treat otitis media. The total annual treatment costs for pneumococcal disease amounts to
nearly 200 million dollars a year.
Increased resistance to penicillin and other important classes of antimicrobials has
complicated the management of S. pneumoniae infections in recent years
By Omita Trivedi and Neha Gandhi
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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
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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
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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
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8. Efficacy was assessed in a randomized, double-blinded clinical trial in a
Multiethnic population at Northern California Kaiser Permanente (NCKP) from
October 1995 through August 20, 1998, in which 37,816 infants were randomized to
receive either Prevnar® or a control vaccine (an investigational meningococcal
group 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 18,910
children.
By Omita Trivedi and Neha Gandhi
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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
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10. Prevnar® is indicated for active immunization of infants and toddlers against
invasive disease caused by S. pneumoniae due to capsular serotypes included in
the 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 against
otitis media caused by serotypes included in the vaccine. However, for vaccine
serotypes, protection against otitis media is expected to be substantially lower than
protection against invasive disease.
By Omita Trivedi and Neha Gandhi
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11. Hypersensitivity to any component of the vaccine, including diphtheria toxoid, is a
contraindication to use of this vaccine.
This vaccine will not protect against s. pneumoniae disease caused by serotypes unrelated
to those in the vaccine, nor will it protect against other microorganisms that cause
invasive infections such as bacteremia and meningitis or non-invasive infections such as
otitis media.
This vaccine should not be given to infants or children with thrombocytopenia or any
coagulation disorder that would contraindicate intramuscular injection unless the
potential benefit clearly outweighs the risk of administration. If the decision is made to
administer this vaccine to children with coagulation disorders, it should be given with
caution.
Immunization with Prevnar® does not substitute for routine diphtheria immunization.
By Omita Trivedi and Neha Gandhi
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12. Prevnar® is for intramuscular use only. Prevnar® SHOULD UNDER NO
CIRCUMSTANCES BE ADMINISTERED INTRAVENOUSLY. The safety and
immunogenicity for other routes of administration (eg, subcutaneous) have not
been 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-grade
fever, are not generally contraindications to vaccination. The administration of
Prevnar should be postponed in subjects suffering from acute severe febrile illness.
By Omita Trivedi and Neha Gandhi
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13. Children receiving therapy with immunosuppressive agents (large amounts of
corticosteroids, antimetabolites, alkylating agents, cytotoxic agents) may not
respond optimally to active immunization.
As with other intramuscular injections, Prevnar® should be given with caution to
children on anticoagulant therapy.
Simultaneous Administration with Other Vaccines:
During clinical studies, Prevnar® was administered simultaneously with DTaP and
HbOC, IPV, Hep B vaccines, MMR, and Varicella vaccine. Thus, the safety
experience with Prevnar® reflects the use of this product as part of the routine
immunization schedule.
By Omita Trivedi and Neha Gandhi
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14. The majority of the safety experience with Prevnar® comes from the NCKP Efficacy
Trial in which 17,066 infants received 55,352 doses of Prevnar®, along with other
Routine childhood vaccines through April 1998
Of the 17,066 subjects who received at least one dose of Prevnar® in the efficacy
trial, 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
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15. In the Kaiser efficacy study in which 17,066 children received a total of 55,352
Doses of Prevnar® and 17,080 children received a total of 55,387 doses of the
Control 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
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16. In addition to reports in clinical trials, the following adverse events have been reported
since market introduction of Prevnar® worldwide. The following adverse events were
included based on strength of causal association, severity, or frequency of reporting for
Prevnar®.
 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
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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
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18. Vaccination schedule for infants and toddlers
Dose: 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
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19. By Omita Trivedi and Neha Gandhi
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20. Product Information
 Product Type – Vaccine
 Route of Administration - Intramuscular
 NDC Product Code (Source) – 0005-1970
Marketing Information
 Marketing Category – BLA
 Application Number - BLA103905
 Marketing Start Date - 03/01/2000
Labeler
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
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21. The 6 additional serotypes are 1, 3, 5, 6A, 7F, and 19A
Like Prevnar 7, Prevnar 13® does not provide 100% protection against vaccine
serotypes or protect against nonvaccine serotypes.
By Omita Trivedi and Neha Gandhi
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22. Prevnar 13® builds upon the scientific foundation of Prevnar® 7 by providing
coverage against 6 additional serotypes that can cause IPD in young children.
This includes serotype 19A, which is the leading cause of IPD in children less
than 5 years of age and has become increasingly resistant to multiple
antibiotics.
Approved for use in children 6 weeks through 5 years of age and for adults
over 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 vaccine
serotypes or protect against nonvaccine serotypes.
By Omita Trivedi and Neha Gandhi
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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
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24. Prevnar 13 is to be administered as a single dose of 0.5 mL to adults 50
years and older including those previously vaccinated with a
pneumococcal polysaccharide vaccine.
Overdose with Prevnar 13 is unlikely due to its presentation as a pre-filled
syringe.
However, in infants and children there have been reports of overdose with
Prevnar 13 defined as subsequent doses administered closer than
recommended to the previous dose. In general, adverse events
reported with overdose are consistent with those that have been reported with
doses given in the recommended pediatric schedules of Prevnar 13.
By Omita Trivedi and Neha Gandhi
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25. Product Information
 Product Type – Vaccine
 Route of Administration - Intramuscular
 NDC Product Code (Source) – 0005-1971
Marketing Information
 Marketing Category – BLA
 Application Number – BLA125324
 Marketing Start Date - 03/01/2010
Labeler
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
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26. 1. http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7abf4185-109d-4e3c-
5da7-0b0658921637
2. http://www.biotech.ca/en/what-biotech-is/benefits.aspx
3. http://www.pfizerpro.com/resources/salesrep_private/minisites/prevnar/docs/
PrevnarExitLetter.pdf
4. Kim et al. Analytical Biochemistry Vol 347, Issue 2, Pages 262–274
5. Pletz et. al. International Journal of Antimicrobial Agents, 2008
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