WHO prequalifies Serum's meningitis vaccine for infant use
This article was originally published in Scrip
The World Health Organization (WHO) has prequalified an India-made meningitis A vaccine for use in infants – a move that will facilitate routine immunization of babies in the meningitis belt of sub-Saharan Africa.
The WHO decision means that the new, 5μg dose of MenAfriVac (meningococcal A conjugate vaccine) made by the Serum Institute of India meets international standards of quality, safety, and efficacy and can be administered to children less than one year of age in Africa. MenAfriVac was earlier authorized for use in children and young adults, aged 1-29 years.
A statement from Meningitis Vaccine Project (MVP) – a partnership between the health non-profit PATH and WHO and the Serum Institute of India – said in the four years since its introduction in Africa, MenAfriVac had had an ''immediate and dramatic'' impact in breaking the cycle of meningitis A epidemics.
"But epidemics will return when rising numbers of unprotected newborns become a larger proportion of the total population over time. Now, with this decision, health officials will be able to ensure that population-wide protection is sustained by routinely immunizing infants," Dr Marie-Pierre Préziosi, director of MVP, said.
Earlier, a study published in The Lancet found the MenAfriVac vaccine had a huge impact on cases of meningitis, with the incidence of meningitis of any kind dropping by 94% following a mass immunization campaign in Chad, West Africa.
The MVP, which was formed in June 2001 with the goal of eliminating epidemic meningitis as a public health problem in sub-Saharan Africa, was one of the earliest product development partnerships funded by the Bill & Melinda Gates Foundation.
Serum Institute
Meanwhile, the Pune-based Serum Institute indicated that MenAfriVac was, in general, comparable to newer vaccines such as GSK's Nimenrix (meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine), though the latter had not been launched when trials on MenAfriVac were done.
''Based upon the literature, we can say that in terms of efficacy both the vaccines are comparable with respect to invasive meningococcal disease caused by meningococcus group A,'' Dr Suresh Jadhav, executive director of Serum, told Scrip.
He also said that Serum was working on a pentavalent meningococcal vaccine involving serotypes A, C, Y, W-135, X, which was ''more relevant'' to the meningitis belt countries.
On the duration of protection offered by MenAfriVac and whether a booster may be required, Dr Jadhav said that based on the conjugate vaccine experience, in an age group of 2 to 55 years, a single dose was ''good enough'' for life long immunity. However, in infants below one year of age, an additional booster dose was recommended.
The MVP statement referred to clinical studies that were conducted to determine the safety, immunogenicity, and optimal dosage and immunization schedule for administering MenAfriVac to infants and toddlers alongside other routine childhood vaccines in the African meningitis belt countries.
Results from two infant clinical studies in Ghana and Mali and vaccine introduction impact data were presented to the WHO Strategic Advisory Group of Experts on Immunization (SAGE) in October 2014. The experts concluded that a one-dose schedule at nine months of age or older was recommended to achieve sustainable disease control following the initial mass campaigns in 1-29 year olds, MVP said.
MenAfriVac, which is said to have been developed at less than one tenth the cost of a typical new vaccine, was priced below $0.50 per dose when it was launched in 2010. The current price for the 10 mcg composition is $0.60 per dose while the WHO-prequalified 5mcg composition is priced at around $0.50 per dose, Dr Jadhav said.
Serum said that while MenAfriVac was generally targeted at the Sub-Saharan African meningitis belt, demand from other countries could also be met if required. MenAfriVac, which received marketing authorization for India in 2012, is also available for sale in the country.
Since vaccination campaigns began in 2010, MenAfriVac had been administered to more than 215 million people in 15 countries of the African meningitis belt including Cameroon, Chad, Ethiopia, Ghana, Mali, Nigeria, Senegal, Sudan and Togo.
The WHO was already working with African countries to ensure a smooth transition from mass campaigns to routine immunization. Seven countries (Burkina Faso, Cameroon, Chad, Ghana, Mali, Niger, and Nigeria) are expected to introduce MenAfriVac in their routine systems as early as this year, while mass vaccination campaigns would continue in remaining countries.