India based pharmaceutical companies are also in the vaccine race. Pune-based Gennova Biopharmaceuticals is planning to kick off early- to mid-stage human trials of its Covid-19 vaccine candidate “soon”. For this purpose, it would be enrolling around 620 participants across several sites over the next few months.

Gennova CEO-Dr Sanjay Singh said, “We have started the processes. We hope to start phase 1 soon. We will present our phase 1 data to the DCGI (Drug Controller General of India), before starting the second phase, and so the timeline for the trials to be completed will depend on these factors.”

“For phase 1, we have got two sites where we will be starting enrolment soon,” he said, adding that around 120 volunteers will be registered in the first phase at two sites, KEM Hospital, Pune, and a government hospital in Kolhapur. Singh further said, “We are looking at enrolling 500 participants for phase 2 trials and this will go into many sites. I hope it will be 6-10 sites.”

The DCGI, who heads India’s apex drug regulator, last week gave Gennova the green light for phase 1/2 trials. If successful, the vaccine may be the first indigenously developed vaccine using mRNA technology that could potentially use India’s existing cold chain capacity in its distribution.

This is the same platform used by Pfizer/BioNTech and Moderna and the US National Institutes of Health (NIH) to make their vaccine. Preliminary information released on the two vaccines with respect to late-stage trials shows that they have an efficacy of around 94-95 percent.

According to the Ministry of Science and Technology, Gennova’s candidate, known as HGCO19, is “stable” at 2°C to 8°C for two months. On the other hand, the Pfizer/BioNTech vaccine requires deep freeze technology to be stored at around -75°C and can be kept in 2°C to 8°C refrigerated units for up to five days. Moderna’s candidate can survive in these refrigerated temperatures for up to a month.