Updated on 18 March 2013
The company has state-of-the-art facilities and the best equipment for each and every step. "It gives us very good control over the manufacturing process in terms of quality and reproducibility. For example, our fermentors from Switzerland have a beautiful control system. Once you set the parameters, then it runs on its own, thereby guaranteeing the quality of the product. For downstream, we use the GE chromatography system. It gives good and consistent supply of the product. Thus we have the technology and process to scale-up from milligram to gram," he adds.
Once the product is manufactured, the company is responsible for its delivery to the Mumbai airport, from where Unicef takes on the responsibility. Thus, the product does not require much marketing efforts by Serum. "Unicef coordinates with the local health ministries for mass immunization campaigns. The program includes 25 sub-Saharan countries," says Dr Malviya. The company is committed to producing MenAfriVac for Unicef till 2017-18 for carrying out the large-scale immunization campaigns. After that, the company can take the product to other countries.
MenAfriVac has been introduced through a two-pronged approach. One is mass vaccination to gain immediate benefits and the other is through integrating it in the routine childhood vaccination programs. Comprehensive mass immunization campaigns for one-year to 29-year-olds with a single dose of MenAfriVac are the cornerstones in the vaccine introduction plan. The strategy aims to reduce bacterial carriage and transmission and thereby rapidly reduce disease-related morbidity and mortality rates. The first three countries for the phased vaccine plan were Burkina Faso, Mali and Niger. The first round of vaccination took place in September 2010 and about 100 million have already been vaccinated with this single-shot lifelong effective vaccine till now.
The Men A conjugate vaccine is filled in 5mL glass vials (type I, USP), stoppered with grey bromobutyl rubber closures, type-slotted and after freeze-drying closed with flip-off aluminium white color seal. The lyophilized vaccine vial contains a powder of Meningococcal group A polysaccharide conjugated to Tetanus Toxoid protein. The vaccine is provided along with MenAfrivac Diluent. The diluent ampoule contains aluminium phosphate as an adjuvant and a preservative. The vaccine also has a vaccine vial monitor label. It is supplied in a box containing 50 vials (10 doses in each vial) and a box containing five blister trays of 10 ampoules of diluent.