**Summary:**
This document addresses Lok Sabha Unstarred Question No. 3318, concerning India's first malaria vaccine, R21/Matrix-M, co-developed by the University of Oxford and the Serum Institute of India. The question sought details regarding regulatory approval, rollout timeline, impact on India's malaria elimination goals under the National Framework for Malaria Elimination (NFME), and government measures to ensure access, affordability, and large-scale deployment, particularly in highly affected regions.
The Minister of State in the Ministry of Health and Family Welfare, Smt. Anupriya Patel, responded that an expert committee reviewed the matter of malaria vaccine use in India. The committee recommended against adopting malaria vaccines at this time, as India does not meet the criteria for their use. The vaccines are indicated for moderate to high transmission settings with a risk of malaria deaths in children. Therefore, the vaccine has not received regulatory approval for use in the country.
Key Entities Referenced
R21 Matrix M: India's first malaria vaccine co-developed by the University of Oxford and the Serum Institute of India.
University of Oxford: A university that codeveloped the R21 Matrix M malaria vaccine.
Serum Institute of India: An organization that codeveloped the R21 Matrix M malaria vaccine.
National Framework for Malaria Elimination: A framework referred to in the context of India's malaria elimination goals.
SMT. ANUPRIYA PATEL: The Minister of State in the Ministry of Health and Family Welfare, who provided the answer to the parliamentary question.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health and family welfare policies and programs.
Malaria: A mosquito-borne infectious disease that is addressed by the malaria vaccine and elimination programs.
Lok Sabha: The lower house of the Parliament of India, where the unstarred question was raised.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 3318
TO BE ANSWERED ON08.08.2025
INDIA’SFIRSTMALARIAVACCINE
3318: SHRISUDHEER GUPTA:
SHRIDHAIRYASHEELSAMBHAJIRAO MANE:
SHRIMANISH JAISWAL:
SHRICHAVAN RAVINDRAVASANTRAO:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) whether India’sfirst malariavaccine,R21/Matrix-M, hasbeen co-developedbythe
University of Oxford andthe SerumInstitute of India and if so, the detailsthereof;
(b) whether the vaccinehasreceived regulatoryapproval for use inthe country;
(c) if so, the detailsthereof alongwith the timelinefor itsrollout;
(d) if not,the time by which it islikelytobe availableinthe market;
(e) the mannerinwhich the said developmentislikelytobe helpful inIndia’sMalaria
Eliminationgoalsunder National Frameworkfor Malaria Elimination (NFME); and
(f) the steps taken/beingtaken bythe Government toensure access, affordability andlarge
-scale deploymentof the vaccine,particularlyinhighlyaffected regions?
ANSWER
THEMINISTEROFSTATEINTHEMINISTRYOFHEALTHANDFAMILYWELFARE
(SMT.ANUPRIYAPATEL)
(a) to (f) The matter for use of Malaria vaccine in context of India has been reviewed in a
duly constituted expert committee which recommended that India does not fall within the
criteria for adopting Malaria vaccines as the vaccines are used for moderate to high
transmission settings with a risk of Malaria deathsinchildren.
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