GlaxoSmithKline Biologicals SA
Serum Institute of India Pvt. Ltd.
EMA (Mosquirix)
CDSCO India (R21)
2015 (outside Europe under Article 58)
2023
2022
2023
Plasmodium falciparum circumsporozoite protein (CSP), recombinant
Plasmodium falciparum CSP-derived fusion antigen
Saccharomyces cerevisiae
Hansenula polymorpha
AS01E (Saponin QS-21 and 3-deacylated monophosphoryl lipid A)
Matrix-A (85 parts) and Matrix-C (15 parts) with phospholipid and cholesterol
None
None
Must be reconstituted with the AS01E adjuvant prior to use.
Not required
Lyophilised active component to be reconstituted with excipient diluent before use
Liquid: ready to use
2 doses in two vial set - powder and suspension (0,5ml/dose)
1 or 2 dose glass (type 1) vial (0.5ml/dose)
Intramuscular
Intramuscular
36 months
24 months
2 °C to 8 °C
2 °C to 8 °C
Type 14
Type 14
9.92 - carton of 50 two vials sets
7.03 (two-dose vial) carton of 50 vials
14.06 (one-dose vial) carton of 50 vials
First dose from 5 months of age; the minimum interval between any dose is 4 weeks.
First dose from 5 months of age; the minimum interval between any dose is 4 weeks.
Complete series with the same product whenever feasible; restarting the series is not recommended.
Complete series with the same product whenever feasible; restarting the series is not recommended.
To achieve prolonged protection, fourth dose should be given 6-18 months after the third dose.
To achieve prolonged protection, fourth dose should be given 6-18 months after the third dose.
Clinical trial and pilot data indicate that the most serious adverse event associated with RTS,S/AS01 is febrile seizures, occurring within 7 days (mainly within 2–3 days) post-vaccination, with an attributable risk of approximately 2.5 per 1,000 doses administered. The seizures resolved without long-term consequences. The most commonly reported adverse reactions were fever (27%) followed less frequently by irritability, and injection site reactions such as pain and swelling.
On the basis of clinical trial data, the most serious adverse reaction associated with R21/Matrix-M is febrile seizures within 7 days (mainly within 2–3 days) post-vaccination, with an attributable risk of 1 per 2800 doses of R21 Matrix-M administered. The seizures resolved without long-term consequences. The most commonly reported adverse reactions were fever (38%), followed less frequently by irritability, and injection site reactions such as pain and swelling.
Yes
Yes
Pricing information for UNICEF procurement can be found at: https://www.unicef.org/supply/documents/malaria-vaccine-price-data
UNICEF. Malaria vaccine questions and answers. https://www.unicef.org/supply/documents/malaria-vaccine-questions-and-a…
Pricing information for UNICEF procurement can be found at: https://www.unicef.org/supply/documents/malaria-vaccine-price-data
UNICEF. Malaria vaccine questions and answers. https://www.unicef.org/supply/documents/malaria-vaccine-questions-and-a…
N/A
N/A
