Why is it in the News?

The World Health Organization (WHO) on Thursday added the R21/Matrix-M malaria vaccine, developed by Oxford University and manufactured by Serum Institute of India, to its list of prequalified vaccines.

News Summary:

• The R21/Matrix-M malaria vaccine, developed by Oxford University and produced by the Serum Institute of India, has received prequalification from the World Health Organization (WHO), marking a significant step in global efforts to combat malaria.
• This achievement follows the prequalification of the RTS, S/AS01 vaccine in July 2022, making R21 the second malaria vaccine to gain the WHO's approval.
  • Prequalification means larger access to vaccines as a key tool to prevent malaria in children.
• The WHO employs rigorous international standards during the prequalification process, conducting a comprehensive evaluation to ensure the safety, efficacy, and adherence to global manufacturing standards of the vaccines.
• Ongoing measures, such as regular re-evaluation, site inspections, and targeted testing, are implemented to uphold prequalified vaccines’ continued safety and effectiveness.

What is a Prequalified Vaccine?

• The World Health Organization (WHO) defines a prequalified vaccine as one that has successfully completed a comprehensive three-step process prior to approval.
  • Thorough Data Evaluation: The first step involves a meticulous examination of relevant data associated with the vaccine.
  • Sample Testing: The second step includes rigorous testing of vaccine samples.
  • Manufacturing Site Inspection: The final step encompasses an inspection of the pertinent manufacturing sites by WHO.
• Only when the outcomes of these steps are positive does the vaccine earn inclusion in the WHO list of Prequalified Vaccines?

What is Malaria?

• Malaria is an infectious disease caused by the Plasmodium parasite, transmitted to humans through the bites of infected female Anopheles mosquitoes, which are active mainly during the night.
• While there are numerous types of Plasmodium parasites, only five affect humans and cause malaria.
• Plasmodium falciparum: Predominantly found in Africa, it is the most common and lethal malaria parasite globally, responsible for the majority of malaria-related deaths.
• Plasmodium vivax: Primarily found in Asia and South America, this parasite causes milder symptoms than Plasmodium falciparum but can persist in the liver for up to three years, leading to potential relapses.
• Plasmodium ovale: Relatively uncommon and typically found in West Africa, this parasite can remain dormant in the liver for several years without causing symptoms.
• Plasmodium malariae: Rare and primarily found in Africa.
• Plasmodium knowlesi: Extremely rare and identified in certain parts of Southeast Asia.

Malaria Transmission:

• Upon being bitten by an infected mosquito, the Plasmodium parasite enters the bloodstream, travels to the liver, and matures.
• It then re-enters the bloodstream, invading red blood cells where it undergoes multiplication.
• Periodically, infected blood cells burst, releasing more parasites into the bloodstream.
• While mosquitoes can become infected by biting an already infected person, malaria does not spread directly from person to person.

Symptoms of Malaria:

• The signs and symptoms of malaria encompass fever, chills, general discomfort, headache, nausea, vomiting, diarrhoea, abdominal pain, muscle or joint pain, fatigue, rapid breathing, rapid heart rate, and cough.
• Recognizing these symptoms is crucial for prompt diagnosis and treatment.

What is the Status of Malaria in India?

• Given its predominantly tropical climate, a significant portion of India has a historical prevalence of malaria, and the country holds the distinction of being where Nobel Prize winner Sir Ronald Ross discovered the malaria parasite cycle involving Anopheles mosquitoes as the definitive host.
• While India has made substantial progress in the direction of malaria elimination, there remains a considerable journey ahead.
• According to the World Malaria Report 2023, India contributed to 66% of malaria cases within the World Health Organization’s South-East Asia region in 2022.
• Additionally, India and Indonesia jointly accounted for approximately 94% of all malaria-related deaths in the region last year.
• The report highlighted that nearly 46% of all cases in the region were attributed to Plasmodium vivax, a protozoal parasite and human pathogen.

What are the Challenges in Malaria Elimination?

• Eliminating malaria in India faces several challenges, primarily stemming from the predominant engagement of the private sector in diagnosing and treating the disease.
  • This sector often encounters issues related to misdiagnosis and mistreatment.

Key challenges include:

• Limited Regulation in the Private Sector: Private doctors and clinics operate without an obligation to adhere to government guidelines, utilize recommended drugs, or report malaria cases to state authorities.
• Disproportionate Malaria Treatments in the Private Sector: In 2015, a substantial 86 million malaria treatments were procured in the private sector, in stark contrast to the meagre 2 million in the public sector.
• Proliferation of Artemisinin Monotherapy: The private sector annually acquires nearly 10 million injections of Artemisinin Monotherapy, a treatment strongly discouraged in India and globally due to its role in accelerating the development of lethal drug resistance.
• Irony of Drug Misuse: Remarkably, India, the largest supplier of high-quality approved malaria drugs globally, grapples with the ironic misuse of malaria drugs within its own borders.

Challenges in Creating a Malaria Vaccine:

The progress toward developing a malaria vaccine encounters various impediments:

• Absence of a Conventional Market: The absence of a conventional market poses a significant hindrance to the development of a malaria vaccine.
• Limited Developer Engagement: The involvement of only a few developers further complicates the landscape for malaria vaccine development.
• Technical Complexity: The technical intricacies associated with creating a vaccine against a parasitic infection, such as malaria, present substantial challenges.
• Complexity of Malaria Parasites' Life Cycle: Malaria parasites exhibit a complex life cycle, and there exists a limited understanding of the intricate immune response to malaria infection.
• Genetic Complexity of Malaria Parasites: The genetic complexity of malaria parasites, generating thousands of potential antigens, adds an additional layer of difficulty to the development of an effective vaccine.

Initiatives Taken by India for Malaria Eradication:

• Since 2000, India has successfully reduced malaria cases by more than half and malaria-related deaths by over 66%.
• In 2016, the country introduced its inaugural National Framework for Malaria Elimination (2016-2030), outlining a vision for a malaria-free nation by 2027 with complete elimination targeted by 2030.
• In 2019, the Government of India demonstrated its commitment by increasing funding for the National Vector Borne Disease Control Programme by over 25%.
• Furthermore, India augmented its support as a donor to the Global Fund to Fight AIDS, Tuberculosis, and Malaria, reaffirming its dedication to combating these vector-borne diseases on a global scale.