Serum Institute yet to get go-ahead for next phase of trials
Serum Institute yet to get go-ahead for next phase of trials
ADVERTISEMENT
As swine flu deaths in the city near the 200 mark, there is some more bad news. The indigenous H1N1 vaccine being developed by the Serum Institute of India (SII) is likely to get delayed.
Having completed Phase I trials successfully, and even submitted the data a fortnight ago, the SII is yet to get a go-ahead from the Drug Controller General of India for the next phase of trials.
Officials of the SII said that the file is caught in red-tape and no word has yet come on why approval is pending. "We applied a couple of weeks ago for permission to start Phase II clinical trials for H1N1 vaccine.
Neither have we received permission, nor have they stated any doubts or have any queries. Frankly, we don't know why it is taking so long when this is a high priority subject," said Dr Surendra Jadhav, executive director, SII.
On the deadline for the vaccine reaching the masses, Jadhav said he was unsure how much the delay in permissions would affect the market release of the H1N1 vaccine.
"It is unlikely that the vaccine will come out in the next month and the longer they take for approvals, the longer will be the delay in market release of the vaccine. We have no choice but to wait," added Jadhav.
The Phase I trials of the H1N1 vaccine on 50 volunteers was successfully completed in Ahmedabad. The Phase II trials in which 300 volunteers are involved are to take place in Pune, Ahmedabad, Bangalore, Lucknow and Ludhiana. The SII is working on two types of vaccines, a nasal and an injectable one.
Subscribe today by clicking the link and stay updated with the latest news!" Click here!
