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Meningitis A vaccine breaks barrier; first to gain approval to travel outside cold chain
Date:11/14/2012

ATLANTA, 14 November 2012Signaling a potential breakthrough for immunization programs in resource-poor countries, researchers today announced at the American Society of Tropical Medicine and Hygiene (ASTMH) conference that regulatory authoritiesafter conducting a rigorous review of stability datawill for the first time allow a vaccine in Africa to be transported and stored for as long as four days without refrigeration or even an icepack.

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 40C for up to four days, a decision that 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 Organization (WHO) Vaccines Pre-qualification Programme, was revealed during a presentation this afternoon at the ASTMH conference in Atlanta by Godwin Enwere, MD, medical director for the Meningitis Vaccine Project. The regulatory approval has the effect of permitting the re-labeling of MenAfriVac, while ensuring that the vaccine remains effective and safe throughout its life cycle.

Costing less than US$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. 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.
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Contact: Coimbra Sirica
CSirica@burnesscommunications.com
301-943-3287
Burness Communications
Source:Eurekalert

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