Meningitis A vaccine breaks barrier: first to gain approval to travel outside cold chain

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MenAfriVac, a meningitis A vaccine, recently received approval to be kept in a controlled temperature chain at temperatures of up to 40 degrees Celsius for up to four days.

“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,” Michel Zaffran, the director of Optimize, a PATH-World Health Organization collaboration, said. “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.”

A team of experts consisting of experts from WHO, PATH, Health Canada and the Serum Institute of India, Ltd., analyzed the heat stability of MenAfriVac prior to approval for travel outside the cold chain.

“Vaccines save and improve lives wherever they are used, but reaching the millions of children in last mile communities like those in rural Africa continues to challenge us,” Orin Levine, the director of vaccine delivery at the Bill & Melinda Gates Foundation, said. “Today’s announcement marks a new milestone because it allows us to extend the delivery of the MenAfriVac vaccine from the traditional cold chain and reach more people across Africa, safely and efficiently.”

From Dakar to Addis Ababa, a region known as the meningitis belt, as many as 450 million people are at risk from meningitis. Meningitis A epidemics occur every seven to 14 years and can be devastating to young adults and children.

“The new flexibility in delivering this vaccine represents a huge step forward,” Zaffran said. “It took the work of a dedicated team to break through political, operational, and regulatory barriers to get this vaccine re-labeled.”

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