New Delhi: Pune-based Gennova Biopharmaceuticals Thursday said India’s very own messenger RNA (mRNA)-based vaccine against Covid-19 could be stored at around 2 to 8 degrees Celsius unlike American pharma giant Pfizer’s much-hyped vaccine candidate, which needs ultra cold storage technology.
Pfizer, along with German biotechnology firm BioNTech SE, had Monday announced that their experimental vaccine — made through the same mRNA technology — has shown more than 90 per cent efficacy in stopping SARS-CoV-2 infections.
Since the announcement, mRNA technology-based vaccines have taken the lead in the race for a Covid vaccine but alongside, it is being labelled as the “most fragile vaccine” as health officials are worried about its distribution process as they need to be stored at minus 75 degrees Celsius (plus-minus 15 degrees).
But the Indian vaccine maker told ThePrint that while the emerging concerns about storage of mRNA vaccine are “genuine”, it added their technology would not require ultra cold conditions.
“The concerns for the ultra cold storage of mRNA-based vaccines are genuine,” said Sanjay Singh, CEO, Gennova Biopharmaceuticals, in an exclusive interview to ThePrint.
“The reason is that the ultra low temperature stabilises the mRNA against degradation. Since Gennova’s Covid-19 vaccine candidate is also an mRNA, it is also subjected to degradation,” he said.
Singh, however, added: “We focused our approach from day one, and scientists at Gennova are developing a novel technology to stabilise the mRNA at 2 to 8 degrees Celsius, which is much more amenable logistically for vaccine deployment.”
“There is no other alternative than to work towards an mRNA vaccine formulation that can be stored and shipped at 2 to 8 degrees Celsius.”
He also said their preliminary results on the vaccine candidate’s stability at 2 to 8 degrees Celsius are promising. “And trying our best to circumvent this gargantuan logistics challenge through technological excellence,” Singh added.
Trial likely to be completed by March
The trial for the vaccine, which was funded by the central government’s Department of Biotechnology, is likely to be completed by March.
“Our vaccine candidate, HGCO19, developed in collaboration with our US partner HDT Bio Inc, is currently being reviewed by the Indian regulatory agency to whom we have asked permission for conducting human clinical trials in India. This will be the first mRNA-based Covid-19 vaccine trial in India. The trial is expected to be completed by March 2021,” Singh said.
He said the human clinical trial’s consent is expected soon, and “we plan to start the clinical trial before the end of the year”.
Experts have welcomed the company’s efforts as a “positive step”.
“While there has been a lot of interest in the mRNA platform for Covid-19 vaccines, there have been many concerns, especially from a low-and-middle-income-countries’ (LMIC) perspective on the need for ultra cold chain requirements, which would be very difficult logistically to organise, as well as fairly costly,” said Anant Bhan, a researcher in global health, bioethics and health policy.
“In this light, the plans by Gennova to address this issue by working to keep their vaccine candidate stable at 2-8 degrees Celsius would be a positive step as this would make the cold chain maintenance and transport of the vaccine candidate more feasible.”
However, he added, “given this approach is under testing and would be a new innovation, it would need to go through adequate testing and quality checks, including in field conditions to inspire confidence”.
Using ‘self-amplifying’ mRNA giving company an edge
The company claimed it is using a “self-amplifying” mRNA, while others use a “non-amplifying” mRNA-based vaccine candidate against Covid-19.
“Compared to the ‘non-amplifying’ mRNA, the ‘self-amplifying’ mRNA provides robust and sustained antigen release, thereby requiring a comparatively lower dose. The ‘self-amplifying’ mRNA gives Gennova an advantage both in terms of production and scalability,” Singh said.
A government press statement issued in July on the Gennova’s vaccine candidate had stated the mRNA vaccine candidate demonstrated “safety, immunogenicity, neutralisation antibody activity in the rodent and non-human primate models”.
“The neutralising antibody response of the vaccine in mice and non-human primates was comparable with the sera from the convalescent patients of Covid-19, above the US-FDA recommended titre of 1:160 for neutralising antibodies,” the statement had added.
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