16 April 2012
By Umesh Isalkar
Three hospitals in Pune are among those selected for conducting final phase of multi–centric clinical trial of the intra–nasal trivalent influenza vaccine which will begin in the country from early next week. Developed by city–based Serum Institute of India (SII), the vaccine promises protection against three predominant strains of currently circulating influenza viruses including swine flu virus.
The vaccine is expected to reach the market by June end. The availability of the vaccine comes at a time when influenza–like illnesses (ILI) are usually on the rise during monsoon. The vaccine will be useful for anyone above two years of age. “The final phase of the clinical trial in humans will begin in three cities – Pune, Ahmedabad and Bangalore – from next week,” Prasad Kulkarni, medical director, SII told TOI on Sunday.
People from three different age groups – from 2 years to 17 years, 18 years to 50 years and 50 years and above – will undergo the trial for the next one–and–a–half months. “A total of 110 people from each age group will undergo trial at selected hospitals in Pune, Ahmedabad and Bangalore during the final phase,” Kulkarni said.
The vaccine will lend protection against H1N1, H3N2 and B/Brisbane influenza viruses in one intra–nasal shot. “The World Health Organisation has decided on the composition of the vaccine,” said Kulkarni. The vaccine has also included protection against swine flu virus (H1N1) which has now become like any other seasonal influenza strain, he added.
The vaccine is especially useful for people in flu risk groups, like those with chronic medical conditions and respiratory infections who continue to be at higher risk of catching the seasonal influenza.
“The vaccine in the final phase will be tested for its capacity to generate immunity, besides, a sort of re–verification of vaccine’s safety on a larger scale will also be done during the final phase,” said Rajeev Dhere, executive director of SII.
The trivalent influenza vaccine is formulated annually, based on the influenza strains projected to be prevalent in the next flu season, Dhere said.
The selection of viruses for seasonal flu vaccines is based on which influenza viruses circulate during the previous season. Sample viruses are collected by 130 national influenza centres in 101 countries and data on disease trends are analysed by four World Health Organisation Collaborating Centres for Reference and Research on Influenza.
Meanwhile, four lakh doses of intra–nasal swine flu vaccine Nasovac will arrive in the market in the first week of May. In the wake of resurgence of H1N1 virus, the SII has decided to roll out the doses. Only a month ago, the institute had to destroy several million doses of the vaccine as they had passed their expiry date.
Since March 14, H1N1 virus has claimed 20 lives in Maharashtra so far. Among them, 15 are from Pune district alone. The remaining three deaths were reported from Nashik and one each from Mumbai and Aurangabad.