Pneumosil > vaccine
“Moving towards equitable access to vaccination.”
The Serum Institute vaccine is designed to protect children in low-resource countries from the kinds of pneumococcus that cause the most disease where they live at less than two-thirds of the usual cost.
The vaccine was developed by Serum Institute and PATH through a collaboration originating in 2008 and with funding contributed by the Bill & Melinda Gates Foundation.
Pneumosil
Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (10-valent) is a sterile suspension of saccharides of the capsular antigens of Streptococcus pneumoniae serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F individually conjugated by using 1-cyano-4-dimethylamino pyridinium tetrafluoroborate chemistry (CDAP) to non-toxic diphtheria CRM197 protein. The polysaccharides are chemically activated and then covalently linked to the protein carrier CRM197 to form the glycoconjugate.
Description:
Individual conjugates are compounded and then polysorbate 20 and aluminium phosphate are added to formulate the vaccine.
Composition:
Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (10-valent) 0.5 ml – 1 doseEach dose of 0.5 ml contains:
Saccharide for serotypes 1, 5, 9V, 14, 19A, 19F, 23F, 7F, 6A – 2 mcg each Saccharide for serotype 6B – 4 mcgConjugated to CRM197 carrier protein Aluminium (as Aluminium phosphate) 0.125 mg
Dose:
0.5 ml by intramuscular injectionKey Points
- Pneumosil is a well-designed vaccine with relevant serotypes yet more affordable than existing PCVs and provide comparable protection by targeting the most prevalent serotypes of the bacterium causing serious illness in developing countries.
- As a PCV, Pneumosil is the same kind of vaccine as the paediatric pneumococcal vaccine already on the market and targets serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F.
- Pneumosil is a WHO prequalified for its procurement by United Nations Agencies and GAVI. This marks an important milestone towards accelerated access of this much needed affordable vaccine for the countries with high disease burden.
- Pneumosil developed through a collaboration spanning over a decade between Serum Institute of India Pvt Ltd and PATH and with funding from Bill and Melinda Gates foundation. Through the collaboration, the vaccine has advanced from preclinical and clinical development to WHO pre-qualification.
- Pneumosil safety and immunogenicity profile is favourable to both currently available licensed and WHO pre-qualified PCVs worldwide. Various seroprevalence assessment estimates Pneumosil serotype coverage similar to other PCVs in high disease burden countries including countries with high seroprevalence of 6A and 19A.
- WHO pre-qualification opens door for this vaccine being accessible that countries can afford and sustain their pneumococcal immunization programme.
Serum Institute – A Leader in Conjugate Vaccines
- Hib Conjugate Vaccine (and also as combination product with DTP)
- MenAfriVac ® (Men A-TT Conjugate Vaccine)
- PNEUMOSIL (Pneumococcal Conjugate Vaccine)
- Poly Meningococcal Conjugate Vaccine
- Maximum number of WHO pre-qualified Vaccines (# 25 Vaccines)
- Excellent supply track record with UNICEF and PAHO for many decades
- Network and Reach to 170+ countries
- Largest supplier of Hib and Meningococcal A Conjugate Vaccines to UNICEF at affordable prices
- Polysaccharides (Hib and Meningococcal A polysaccharides - as process intermediate) produced at SIIPL are used by WHO Reference Laboratory i.e. National Institute of Biological Standards and Control (NIBSC) UK as Reference (Gold) Standards for testing and release of Vaccines from different manufacturers. This is a recognition of the Scientific expertise that exists at SIIPL.