Prevnar® 13
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The Business:
Manufacturer: Pfizer
Pfizer's total sales 2018: $53.6 billion. Reference: 2018 Financial report
Pfizer's vaccine sales 2018: $5.8 billion (Prevnar 13 only). Reference: Financial report, page 18
Prevnar® 13's global sales in 2018:$5,802 million. Reference: 2018 Annual Report p 24
British Columbia Center for Disease Control expense, F/Y 2018/19 for Prevnar® 13$8,972,332 Reference: BCCDC FOIA request by TMOV, 12-06-19
 
The Product:
Description of Vaccine: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
 
Type of vaccine: Pneumococcal Conjugate. Given by Intramuscular injection
Primary medical reference: Package insert for Canada


Concerning Ingredient(s)
Ingredient (follow link to independent info) Quantity Units Reference
aluminum as aluminum phosphate 125 mcg Package Insert




Reported Serious Adverse Events and Awards Given for Injuries from this type of vaccine ( Pneumococcal Conjugate)
(These numbers may include only 1% of actual adverse events, according to the DHS's own study, p 6, line 12, which states, 'Likewise, fewer than 1% of vaccine adverse events are reported.')
CDC Vaccine Type PNEUMOCOCCAL, 13-VALENT VACCINE (PREVNAR)
Serious adverse events, USA, during 2018 (Definition of serious: Note 1, Source: Note 2)960
Number of injury awards paid by VICP (USA) for this vaccine type from 1988 until September 1, 2019 (Note 3)62
Serious adverse events following immunization, Canada, during 2018, for the group [Pneu-C, Pneu-C-10, Pneu-C-13, Pneu-C-7, Pneu-P, Pneu-P-23] which includes this type of vaccine. (Note 4)109 (Includes pneumococcal conjugate and pneumococcal polysaccharide)



Adverse reactions
Age of patient Intensity Adverse reaction Frequency Reference
6 weeks to 5 years n/a decreased appetite very common (> 10%) Canadian Product Monograph, p 59
6 weeks to 5 years n/a irritability very common (> 10%) Canadian Product Monograph, p 59
6 weeks to 5 years n/a drowsiness/increased sleep very common (> 10%) Canadian Product Monograph, p 59
6 weeks to 5 years n/a restless sleep/decreased sleep very common (> 10%) Canadian Product Monograph, p 59
6 weeks to 5 years n/a fever very common (> 10%) Canadian Product Monograph, p 59
6 weeks to 5 years n/a any pain, tenderness, redness, swelling or hardness at the vaccination-site very common (> 10%) Canadian Product Monograph, p 59
6 weeks to 5 years n/a diarrhea, vomiting common (> 1% and < 10%) Canadian Product Monograph, p 59
6 weeks to 5 years n/a rash common (> 1% and < 10%) Canadian Product Monograph, p 59
6 weeks to 5 years n/a fever > 39°C common (> 1% and < 10%) Canadian Product Monograph, p 59
6 weeks to 5 years n/a pain or tenderness at the vaccination-site interfering with movement common (> 1% and < 10%) Canadian Product Monograph, p 59
6 weeks to 5 years n/a crying uncommon (> 0.1% and < 1%) Canadian Product Monograph, p 59
6 weeks to 5 years n/a seizures (including febrile seizures) uncommon (> 0.1% and < 1%) Canadian Product Monograph, p 59
6 weeks to 5 years n/a urticaria or urticaria-like rash uncommon (> 0.1% and < 1%) Canadian Product Monograph, p 59
6 weeks to 5 years n/a redness, swelling, or hardness at the vaccination-site > 7.0 cm uncommon (> 0.1% and < 1%) Canadian Product Monograph, p 59
6 weeks to 5 years n/a hypotonic-hyporesponsive episode (collapse or shock-like state) rare (> 0.01% and < 0.1%) Canadian Product Monograph, p 59
6 weeks to 5 years n/a hypersensitivity reaction including swelling of the face and/or lips, difficulty in breathing rare (> 0.01% and < 0.1%) Canadian Product Monograph, p 59
very premature babies (born at or before 24 weeks gestation) n/a longer gaps than normal between breaths see product monograph Canadian Product Monograph, p 59
5 to 17 years n/a decreased appetite Very common: >= 10% Canadian Product Monograph, p 59
5 to 17 years n/a irritability Very common: >= 10% Canadian Product Monograph, p 59
5 to 17 years n/a any pain, tenderness (including impaired movement), redness, swelling or hardness at the vaccination-site Very common: >= 10% Canadian Product Monograph, p 59
5 to 17 years n/a drowsiness/increased sleep Very common: >= 10% Canadian Product Monograph, p 59
5 to 17 years n/a restless sleep/decreased sleep Very common: >= 10% Canadian Product Monograph, p 59
5 to 17 years n/a hives (urticaria) Common: <= 10% and > 1% Canadian Product Monograph, p 59
5 to 17 years n/a fever Common: <= 10% and > 1% Canadian Product Monograph, p 59
18 or older n/a decreased appetite Very common: > 10% Canadian Product Monograph, p 60
18 or older n/a headache Very common: > 10% Canadian Product Monograph, p 60
18 or older n/a diarrhea; vomiting (in adults aged 18-49 years) Very common: > 10% Canadian Product Monograph, p 60
18 or older n/a rash Very common: > 10% Canadian Product Monograph, p 60
18 or older n/a New joint pain/aggravated joint pain Very common: > 10% Canadian Product Monograph, p 60
18 or older n/a new muscle pain/aggravated muscle pain Very common: > 10% Canadian Product Monograph, p 60
18 or older n/a chills Very common: > 10% Canadian Product Monograph, p 60
18 or older n/a fatigue Very common: > 10% Canadian Product Monograph, p 60
18 or older n/a any pain, tenderness, redness, swelling or hardness at the injection site Very common: > 10% Canadian Product Monograph, p 60
18 or older n/a limitation of arm movement Very common: > 10% Canadian Product Monograph, p 60
18 or older n/a vomiting (in adults aged 50 years and over) Common (< 10% and >= 1%) Canadian Product Monograph, p 60
18 or older n/a fever Common (< 10% and >= 1%) Canadian Product Monograph, p 60
18 or older n/a nausea Uncommon (< 1% and >= 0.1%) Canadian Product Monograph, p 60
18 or older n/a Hypersensitivity reaction including swelling of the face and/or lips, difficulty breathing Uncommon (< 1% and >= 0.1%) Canadian Product Monograph, p 60
18 or older n/a enlarged lymph nodes (lymphadenopathy) in the region of the injection site Uncommon (< 1% and >= 0.1%) Canadian Product Monograph, p 60
unspecified n/a anaphylactic/anaphylactoid reaction including shock (cardiovascular collapse) see product monograph Canadian Product Monograph, p 60
unspecified n/a angioneurotic edema see product monograph Canadian Product Monograph, p 60
unspecified n/a erythema multiforme see product monograph Canadian Product Monograph, p 60
unspecified n/a vaccination-site dermatitis see product monograph Canadian Product Monograph, p 60
unspecified n/a vaccination-site urticaria see product monograph Canadian Product Monograph, p 60
unspecified n/a vaccination-site pruritus see product monograph Canadian Product Monograph, p 60



Other Ingredient(s)
Ingredient Quantity Units Notes
saccharide for Streptococcus pneumoniae serotype 1 2.2 mcg
saccharide for Streptococcus pneumoniae serotype 3 2.2 mcg
saccharide for Streptococcus pneumoniae serotype 4 2.2 mcg
saccharide for Streptococcus pneumoniae serotype 5 2.2 mcg
saccharide for Streptococcus pneumoniae serotype 6A 2.2 mcg
saccharide for Streptococcus pneumoniae serotype 7F 2.2 mcg
saccharide for Streptococcus pneumoniae serotype 9V 2.2 mcg
saccharide for Streptococcus pneumoniae serotype 14 2.2 mcg
saccharide for Streptococcus pneumoniae serotype 18C 2.2 mcg
saccharide for Streptococcus pneumoniae serotype 19A 2.2 mcg
saccharide for Streptococcus pneumoniae serotype 19F 2.2 mcg
saccharide for Streptococcus pneumoniae serotype 23F 2.2 mcg
saccharide for Streptococcus pneumoniae serotype 6B 4.4 mcg
CRM197 carrier protein 34 mcg
sodium chloride 4.25 mg
polysorbate 80 100 mcg
succinic acid 295 mcg


Notes:

Note 1- USA - Definition of serious adverse events: According to the CDC's Vaccine Adverse Events Reporting System (VAERS), events are classified as serious when any of the following outcomes are associated with the event: Death, Permanent Disability, Life Threatening, Hospitalized, Existing Hospitalization Prolonged, Congenital Anomaly or Birth Defect.

Note 2- United States Department of Health and Human Services (DHHS), Public Health Service (PHS), Centers for Disease Control (CDC) / Food and Drug Administration (FDA), Vaccine Adverse Event Reporting System (VAERS) 1990 - last month, CDC WONDER On-line Database. Accessed at http://wonder.cdc.gov/vaers.html on Sep 28, 2019 1:51:20 AM. A most user-friendly interface for you to access the VAERS database is here. It is presented by the National Vaccine Information Center and is called MedAlerts.

Note 3- VICP is the National Vaccine Injury Compensation Program, Monthly Statistics Report

Note 4- Canada - Definition of serious Adverse Events Following Immunization are those which are life-threatening, result in hospitalization or a prolongation of hospitalization, result in persistent or significant disability, or where the outcome is a birth defect or death, as defined by the World Health Organization. Source: Adverse Events Following Immunization (AEFI) Bi-annual Report from July 1 to December 31, 2018. and Adverse Events Following Immunization (AEFI) Bi-annual Report from January 1 to June 30, 2018.



Babies and children normal body temperature: 97.9°F to 100.4°F (36.6°C to 38.0°C).
Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Ref
Grade 1 - Mild
Grade 2 - Moderate
Grade 3 - Severe
Grade 4 - Life-threatening
Grade 5 - Death