Immunization, Vaccines and Biologicals

Immunization highlights: 2012

Innovation in immunization supply systems

MenAfriVac the first vaccine to gain approval to travel outside cold chain

In October, MenAfriVac, a vaccine against Meningitis A manufactured by Serum Institute of India, received final regulatory approval to be kept outside the cold chain for up to four days at up to 40°C, in a controlled temperature chain (CTC). A pilot project using the CTC approach was conducted in Benin in November as part of the mass vaccination campaign. The pilot was conducted jointly by the Government of Benin, WHO African Region, the Meningitis Vaccine Project (a WHO-PATH partnership to develop MenAfriVac) and Optimize—the WHO-PATH collaboration leading the CTC activities.

In total, over 155 000 people were vaccinated as part of the pilot project, using guidance and training materials developed by WHO’s Immunization Practices Advisory Committee (IPAC). Overall, 100% of supervisors and over 98.7% of vaccinators said if given the choice between using the CTC approach and the regular cold chain for future campaigns, they would choose the CTC approach.

MenAfriVac is the first vaccine intended for use in Africa approved for this type of use, setting a regulatory path for other heat-stable vaccines. The new regulatory approval for this innovative vaccine ― which costs less than US$0.50 per dose ― could help increase vaccination campaign efficiency and coverage across the Meningitis Belt.

"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. 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 controlled temperature chain concept to other vaccines and initiatives, allowing us to save more lives in low-income countries.”

Michel Zaffran, Director of Optimize, the WHO-PATH collaboration to improve immunization systems and technologies.

Related links

Progress and impact of new meningitis vaccine

As October 2012, with the support of the GAVI Alliance, UNICEF, PATH, WHO, and their partners, along with the commitment of national governments, MenAfriVac vaccination campaigns have taken place in Benin, Burkina Faso, Cameroon, Chad, Ghana, Mali, Niger, Nigeria, Senegal, and Sudan and cases of meningitis A in these countries have dropped dramatically. Evidence of herd immunity has already been detected. Recently published studies strongly suggest that epidemics that have ravaged the 26 countries in Africa’s meningitis belt for more than a century can be brought to an end. Read more at: