In a breakthrough, a key India-made meningitis vaccine can now be transported or stored for up to four days without refrigeration, which could help combat the disease in poor countries.
According to researchers, the meningitis A vaccine known as MenAfriVac, created to meet the needs of Africa's meningitis belt, can now be kept in a controlled temperature chain (CTC) at temperatures of up to 40 Degree Celsius for up to four days.
Costing less than USD 0.50 per dose, the innovative vaccine that is manufactured by Serum Institute of India Ltd. (SIIL) has dramatically reduced disease burden in the first countries to introduce it, according to recently-published findings.
The decision could help increase campaign efficiency and coverage and save funds normally spent maintaining the challenging cold chain during the "last mile" of vaccine delivery.
The outcome of the review and decisions of the Drugs Controller General of India (DCGI), supported by a Health Canada analysis and confirmed by the World Health Organisation (WHO) Vaccines Pre-qualification Programme, was revealed during the ASTMH conference in Atlanta by Godwin Enwere, medical director for the Meningitis Vaccine Project.
The regulatory approval has the effect of permitting the re-labelling of MenAfriVac, while ensuring that the vaccine remains effective and safe throughout its life cycle.
MenAfriVac is the first vaccine designed specifically to help health workers eliminate meningococcal A epidemics from Africa's "meningitis belt," which includes 26 countries from Senegal to Ethiopia.
"The potential for some vaccines to remain safely outside the cold chain for short periods of time has been widely known for over 20 years," said Dr Michel Zaffran, director of Optimise, the PATH-WHO collaboration aimed at improving immunisation systems and technologies.
"But this is the first time that a vaccine intended for use in Africa has been tested and submitted to regulatory review and approved for this type of use. And we expect this announcement to build momentum for applying the CTC concept to other vaccines and initiatives, allowing us to save more lives in low-income countries," Zaffran said.
Evidence of the heat stability of MenAfriVac was validated by a team of experts from WHO, PATH, SIIL, and Health Canada.