Ahmedabad-based pharma major Cadila Healthcare (Zydus Cadila), which is readying to start phase 3 clinical trials, claimed that its investigational candidate ZyCoV-D can remain stable even at room temperature for at least three months.
Speaking at a FICCI event, Pankaj Patel, chairman of Zydus Cadila said, “We feel this is a very stable vaccine and would not even need 2 to 8 degrees temperature, but can remain stable even at 30 degree Celsius for about three months at least.” At a cold chain temperature of 2 to 8 degrees, this can be stable for even longer.
This can be a major factor when planning nation-wide vaccine distribution as it would have minimal cold chain requirements when it reaches the hinterland.
Patel also informed that the firm has completed the phase 2 clinical trials and is now analysing the data. It would submit an application for phase 3 trial approval very soon. “So far we have not had any safety concern and even the data from the animal trials is very encouraging,” he added.
Zydus Cadila plans to finish the phase 3 efficacy studies before it applies for marketing authorisation nod from the drug controller, but Patel said that if there are policy changes globally or in India that allows accelerated approval based on phase 1 and 2 data, they would ‘more than happy’ to apply for the same.
ZyCoV-D, India’s first DNA plasmid vaccine has been developed at the Vaccine Technology Center in Ahmedabad.
What is a DNA plasmid vaccine? It is a relatively new vaccine technology and is also considered cost-effective for scaling up. Cells have DNAs in their chromosomes and also outside the chromosomes in a form called plasmids. Scientists insert the virus genetic material into such plasmids that they have obtained from bacteria. The plasmid is then inserted into the body and this triggers an immune response.