P.T. Jyothi Datta
Mumbai, Sept. 1
WYETH is poised to bring its blockbuster a billion-dollar pediatric vaccine for pneumococcal diseases into India. The vaccine is touted to be the first and only vaccine indicated for children up to two years of age.
The estimated Rs 300-crore company is in the process of getting regulatory clearance from the Drug Controller General of India (DCGI) and expects to launch in India "very shortly", said the Wyeth Ltd's Medical Director, Dr Shilpa Patil.
Pneumococcal diseases are illnesses caused by the bacteria Streptococcus pneumoniae or "Pneumococcus".
And when this bacteria affects the brain it causes meningitis; when it invades the lungs it causes bacterial pneumonia; when it affects the bloodstream, it causes bacteremia.
The vaccine assumes significance given that more than one million children below the age of five years are estimated to die every year of pneumococcal infections in developing countries alone.
Dr Patil told Business Line that the vaccine would be imported from global sites in the US or Europe.
The company will also undertake post-marketing surveillance, the official said.
No details were available on how the vaccine would be priced, but it would be administered in a three-plus-one (booster-shot) schedule, Dr Patil said.
Wyeth is already in the process of putting its logistics together to distribute the product.
While the product will be sold through pediatricians, it is not part of the Government programmes in India.
It is, however, part of the immunisation schedule in the US, Australia and Canada, the official said.
The vaccine is advised for infants below two years and sometimes for children below five years, as they are at the greatest risk for invasive pneumococcal disease.
About 25 to 60 per cent of them are carriers of pneumococci in their throats.
The risks of meningitis and bacteremia are greatest during the first two years of life, the company said.