Serum’s pneumococcal vaccine receives WHO prequalification

Serum’s pneumococcal vaccine receives WHO prequalification

The low-cost pneumococcal vaccine developed by Serum Institute of India, Pune named Pneumocil has recently been prequalified by the World Health Organisation against pneumococcal infections in children.

The vaccine which can now be procured by UN agencies and the vaccine alliance, Gavi, allows it to be accessed by low- and middle-income countries at a price of US $2 per dose which is 30% less than the current price of this vaccine, according to the company.

“We intend making the vaccine available to low- and middle-income countries for about $2 per dose, while countries pay nearly $3 when the vaccine is co-funded by Gavi,” said Dr. Rajeev Dhere, Executive Director of Serum Institute, in a news source.

A phase 3 trial was carried out among 2,250 children in Gambia, Africa.

The trial which led to the prequalification analysed the efficacy of Pneumocil against previously approved pneumococcal vaccine -Synflorix. 2,250 infants were immunised using Pneumocil at 6, 10, and 14 weeks and a booster dose were given to 675 infants at nine months age.

“The efficacy of our vaccine was comparable with the existing approved vaccine tested during the trial,” says Dr. Dhere.

Pneumocil is a conjugate vaccine designed using an optimised manufacturing process by the company as in their previous meningococcal vaccine.

Out of about 90 different existing serotypes of Streptococcus pneumoniae, 10 most prevalent serotypes observed in Asia, Latin America and Africa have been selected in the making of the vaccine. Therefore the vaccine confers wider protection against the bacteria.

The company has reported to have completed the phase-3 trial recently in India and will soon proceed to submit the data to the Drugs Controller General of India (DCGI) for licensing, according to The Hindu.