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Serum Institute set for flu vaccine launch in July

Alka Kshirsagar

Meningitis vaccine trial in final stage

Pune June 14 The Serum Institute of India (SIIL) is launching its conjugate vaccine against haemothillus type B influenza next month under the brand name Hibpro, even as a new meningococcal conjugate vaccine has entered the final phase of trial.

Following clearance from the Drug Controller General of India, Hibpro — a vaccine for bacterial influenza — will be launched for use in India as well as for export to neighbouring countries in July. The expected volume is 100 million doses per year, Dr S.S. Jadhav, Executive Director, SIIL, said.

Referring to the conjugate meningococcal vaccine against meningitis A, Dr Jadhav said that if the Phase 3 trials for the drug are successful then commercial production would begin by the middle of next year. The volumes expected are 40-50 million doses a year.

Should SIIL begin producing the vaccine, it will add around Rs 70 crore to the Poonawala group's topline, which was around Rs 960 crore this year, and should see 20 per cent growth this fiscal. Though at the committed cost of 40 cents per dose the meningococcal vaccine will not contribute much to the bottomline, the intangible returns will be priceless.

Meningitis control

SIIL is developing the meningococcus conjugate vaccine for the Meningitis Vaccine Project (MVP) — a partnership between World Health Organization (WHO) and the Seattle-based non-profit PATH. The Bill and Melinda Gates Foundation pledged $70 million for meningitis control in Africa, including $6.5 million to the Pune institute.

Following the success of Phase 1 trials in India last year, 600 toddlers in Mali and Gambia participated in the Phase 2 trials.

These showed it was safe and produced antibody levels almost 20 times higher than those produced by polysaccharide (un-conjugated) vaccine, meaning that disease protection could last several years. Phase 3 trials will be held in three African countries, and one Indian city later this year.

The vaccine could eventually slash the incidence of epidemics in the 21 sub-Saharan countries that form the "meningitis belt". It is expected to block infection by the serogroup A meningococcus, and therefore extend protection even to the unvaccinated — a phenomenon known as "herd immunity".

According to Dr. F. Marc LaForce, MVP Director, the vaccine will eliminate meningococcal epidemics that have afflicted the continent for more than 100 years.

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