Pre-market human trials of swine flu vaccine to check its efficacy on Indians may start in the next fortnight as the Indian Council of Medical research is in final stages of “positive” negotiations with an international pharmaceutical company in this regard.
“We will finalise the deal with the international vaccine manufacturing company by December 15 with which we will place the order. So far, negotiations have been positive,” a Health Ministry official said.
“Government is negotiating with three international vaccine manufacturers. By next fortnight, the phase IV trials are expected to begin. This will be done to check the safety and the immunogenicity of the foreign-made vaccine on Indian population,” Dr V. M. Katoch, DG, ICMR said.
Sources in the Health Ministry also said international vaccine manufacturer Glaxo Smith Kline has quoted the lowest price and is under consideration.
More than 21,000 people have been affected by swine flu virus in India. Nearly 700 deaths have been reported from different cities here.
Dr. Katoch said, “Since no Indian company is ready yet for the phase IV trial, we are considering the foreign brands as they are already tried, tested and in use in other countries.
“Zydus Cadila of Ahmedabad, the Indian swine flu vaccine manufacturing company, has recently got a nod from the Drug Controller General of India to carry out human studies of its vaccine. They can carry it out any time in December.”
