NeisVac-C®
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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
NeisVac-C®'s global sales in 2018:N/A. Reference: 0
British Columbia Center for Disease Control expense, F/Y 2018/19 for NeisVac-C®$1,386,140 Reference: BCCDC FOIA request by TMOV, 12-06-19
 
The Product:
Description of Vaccine: Meningococcal Group C-TT Conjugate Vaccine, Adsorbed
 
Type of vaccine: Meningococcal C 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 hydroxide Al3+ 0.5 mg Package Insert




Reported Serious Adverse Events and Awards Given for Injuries from this type of vaccine ( Meningococcal C 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 Not listed by CDC
Serious adverse events, USA, during 2018 (Definition of serious: Note 1, Source: Note 2)0
Number of injury awards paid by VICP (USA) for this vaccine type from 1988 until September 1, 2019 (Note 3)45 (Includes Meningococcal C Conjugate and Meningococcal Quadrivalent Conjugate)
Serious adverse events following immunization, Canada, during 2018, for the group [Men-C, Men-C-ACYW-135, Men-C-C, Men-B] which includes this type of vaccine. (Note 4)78 (Includes Meningococcal C Conjugate and Meningococcal Quadrivalent Conjugate)



Adverse reactions
Age of patient Intensity Adverse reaction Frequency Reference
all ages n/a injection site redness 5% to 50% Monograph, p 7
all ages n/a injection site tenderness or pain 14% to 71% Monograph, p 7
all ages n/a injection site swelling 8% to 31% Monograph, p 7
all ages n/a pain in limb 32% Monograph, p 7
all ages n/a headache 7% to 26% Monograph, p 7
infants and toddlers n/a crying and irritability 22% to 53% Monograph, p 7
infants and toddlers n/a drowsiness/somnolence/impaired sleeping 12% to 53% Monograph, p 7
infants n/a vomiting/nausea/diarrhea 12% Monograph, p 7
infants n/a loss of appetite 27% Monograph, p 7
all ages n/a fever 1% to 7% Monograph, p 7
children n/a loss of appetite 1% to 7% Monograph, p 7
children n/a vomiting/nausea/diarrhea 3% to 5% Monograph, p 7
older children and adults n/a muscle pain 6% to 7% Monograph, p 7
children n/a pain in limb 2% Monograph, p 7
all ages n/a drowsiness/somnolence/impaired sleeping 3% to 8% Monograph, p 7
all age groups n/a lymphadenopathy Very rare: <= 0.01% Monograph, p 7
all age groups n/a idiopathic thrombocytopenic purpura Very rare: <= 0.01% Monograph, p 7
all age groups n/a anaphylaxis Very rare: <= 0.01% Monograph, p 8
all age groups n/a hypersensitivity reactions including bronchospasm, facial oedema and angioedema Very rare: <= 0.01% Monograph, p 8
all age groups n/a dizziness Very rare: <= 0.01% Monograph, p 8
all age groups n/a convulsions including febrile convulsions Very rare: <= 0.01% Monograph, p 8
all age groups n/a faints Very rare: <= 0.01% Monograph, p 8
all age groups n/a hypoaesthesia Very rare: <= 0.01% Monograph, p 8
all age groups n/a paraesthesia Very rare: <= 0.01% Monograph, p 8
infants n/a hypotonia Very rare: <= 0.01% Monograph, p 8
all age groups n/a seizures Very rare: <= 0.01% Monograph, p 8
very premature infants n/a apnea Very rare: <= 0.01% Monograph, p 8
all age groups n/a vomiting and nausea Very rare: <= 0.01% Monograph, p 8
all age groups n/a rash Rare: >= 0.01% and < 0.1% Monograph, p 8
all age groups n/a urticaria Very rare: <= 0.01% Monograph, p 8
all age groups n/a pruritis Very rare: <= 0.01% Monograph, p 8
all age groups n/a petechiae and/or purpura Very rare: <= 0.01% Monograph, p 8
all age groups n/a arthralgia Very rare: <= 0.01% Monograph, p 8



Other Ingredient(s)
Ingredient Quantity Units Notes
Neisseria meningitidis group C polysaccharide 10 mcg
tetanus toxoid 10-20 mcg
sodium chloride 4.1 mg


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