All Indian vaccines being developed against the coronavirus will have to be stored at 2-8 degrees Celsius as the logistics have been worked out while considering temperature as a factor, Department of Biotechnology Secretary Renu Swarup said on Tuesday.
Swarup said Bharat Biotech's COVID-19 vaccine Covaxin and Oxford-AstraZeneca's Covishield have robustly undergone immunoassay lab tests. “(For) all our vaccines, we are looking at right now..(we) are targeting 2-8 degree because our logistics are worked out on that basis and we are working on that,” Swarup said at a press briefing.
She said the DNA vaccine candidate being developed by Zydus Cadila, and the Biological E's mRNA vaccine work at storage temperatures of 2-8 degrees Celsius. Unlike the Pfizer and Moderna which requires a minus 70 degree Celsius (cold) chain, this (the Biological E's vaccine candidate) is basically at the 2-8 degree Celsius, Swarup said.
The Zydus Cadila candidate has been granted approval to conduct the phase-3 trial while the Biological E candidate is in its phase-1 clinical trial stage. Swarup said Dr Reddy's Laboratories has partnered with Russia's Gamaleya Institute and a vaccine is being developed for India targeting storage at 2-8 degrees Celsius.
“They (Dr Reddy's Laboratories) have started phase 2/3 trials in the country. They have completed the first part of the phase 2 trial on 1,000 subjects and they are now looking at interim data which is to be analysed. They also have large global trials, like the Astrazeneca and that data is also being looked at. What they are targeting is for India to try and see how it could be at 2-8 degrees,” Swarup said.
There are 30 vaccine candidates in India at different stages. The country's drugs regulator on Sunday granted emergency use approval to Oxford-AstraZeneca's Covishield and also to the indigenously developed Covaxin even though not enough data on the latter's efficacy and safety was available, which has triggered a debate.
Seeking to ally apprehensions on this, Swarup said, These two vaccines which have been spoken about right now, we have had the robust immunoassays which have been studied through within the laboratories. Referring to the Translational Health Science and Technology Institute (THSTI), Faridabad, an institute under the DBT, Swarup said the lab has sets of immunoassays — which are biochemical tests — that run all these vaccines through them.
So anything that comes out of this immunoassay lab gives you the confidence that it has gone through the robust assay system which gives you the immunogenicity and the safety data as we move forward, Swarup said.