Features of the Vaccine:
The vaccine, known as R21/Matrix-M, was developed using US firm Novavax's adjuvant technology. An adjuvant is a substance added to enhance the immune response of a vaccine.
This vaccine has demonstrated effectiveness in various settings, from regions with high seasonal malaria transmission to those with year-round transmission. While the efficacy of three doses declined after a year, a booster shot restored its effectiveness.
One of its significant advantages is its cost, with a price tag of $2-4 per dose, making it comparable to other childhood vaccines and facilitating rapid scale-up at the country level.
Phase III trials included 4,800 children aged 3-5 years from Burkina Faso, Kenya, Mali, and Tanzania.
Why the Delay in Vaccine Development:
The delay in developing vaccines for diseases like malaria is attributed to various challenges. "Neglected" diseases, including malaria,
tuberculosis, and HIV-AIDS, predominantly affect developing and underdeveloped countries. For some of these diseases, the return on investment for vaccine manufacturers is lower,
resulting in significant funding shortfalls. Malaria, for example, faces a $3.8-billion funding gap globally each year.
The intricate genetic makeup of the malaria-causing parasite has also posed technological challenges for vaccine development.
Potential Impact of the New Vaccine:
Malaria remains a significant global health challenge, with 247 million cases and 619,000 deaths reported in 2021. Nearly half a million children, primarily in Africa, succumb to malaria annually.
Despite progress in India, where malaria cases fell from 338,494 in 2019 to 176,522 in 2022, it continues to be prevalent. With the Serum Institute of India (SII) announcing the capacity to produce over 100 million doses annually (soon to be 200 million), this vaccine,
coupled with other public health measures, could contribute to India's goal of malaria elimination by 2030.
Availability in India:
The vaccine is expected to be available globally by mid-2024, but its availability in India remains uncertain. Indian regulations require clinical trials to be conducted within the country.
The next steps include completing the WHO prequalification process, which assesses the quality, safety, and efficacy of medicinal products. This step would enable international procurement for a broader rollout.
The partnership between Oxford University and SII, previously successful with Covishield, is not new.
Existing Malaria Vaccine:
Another malaria vaccine was developed by GSK, a UK drugmaker, and received approval in 2021. However, only 18 million doses are available and will be allocated to 12 African countries over 2023-2025.
Given the high demand compared to the supply, the scalability of the new vaccine becomes crucial in protecting more children rapidly, as endorsed by the WHO.