BOOSTRIX-POLIO

Image may differ from actual product
The Business:
Manufacturer: GlaxoSmithKline
GlaxoSmithKline's total sales 2018: £30.8 billion. Reference: GSK Key Facts
GlaxoSmithKline's vaccine sales 2018: £5.9 billion. Reference: 2018 Annual Report
BOOSTRIX-POLIO's global sales in 2018:. Reference: 0
British Columbia Center for Disease Control expense, F/Y 2018/19 for BOOSTRIX-POLIO$942,023 Reference: BCCDC FOIA request by TMOV, 12-06-19
 
The Product:
Description of Vaccine: (Combined diphtheria, tetanus, acellular pertussis (adsorbed) and inactivated poliomyelitis) vaccine
 Active immunizing agent against infection by diphtheria, tetanus, whooping cough and poliomyelitis
Type of vaccine: Tdap-IPV. Given by Intramuscular injection
Primary medical reference: Package insert for Canada


Concerning Ingredient(s)
Ingredient (follow link to independent info) Quantity Units Reference
aluminum salts 0.5 mg Package Insert




Reported Serious Adverse Events and Awards Given for Injuries from this type of vaccine ( Tdap-IPV)
(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 TETANUS, DIPHTHERIA AND ACELLULAR PERTUSSIS, AND INACTIVATED POLIO VIRUS
Serious adverse events, USA, during 2018 (Definition of serious: Note 1, Source: Note 2)7
Number of injury awards paid by VICP (USA) for this vaccine type from 1988 until September 1, 2019 (Note 3)
Serious adverse events following immunization, Canada, during 2018, for the group [Tdap, Tdap-IPV, Td-IPV, T, TD, Rab ] which includes this type of vaccine. (Note 4)



No further data


Other Ingredient(s)
Ingredient Quantity Units Notes
diphtheria toxoid at least 2.5 Lf
pertussis toxoid 8 mcg
filamentous haemagglutinin 8 mcg
pertactin (69 kDa OMP) 2.5 mcg
type 1 poliovirus 40 D-Antigen Units (DU)
type 2 poliovirus 8 D-antigen units
type 3 poliovirus 32 D-antigen units
tetanus toxoid >=5 Lf
medium 199 not shown
sodium chloride not shown
water for injection not shown
disodium phosphate residue from manufacturing
formaldehyde residue from manufacturing
glutaraldehyde residue from manufacturing
glycine residue from manufacturing
monopotassium phosphate residue from manufacturing
neomycin sulphate residue from manufacturing
polymyxin B sulphate residue from manufacturing
polysorbate 80 residue from manufacturing
potassium chloride residue from manufacturing


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