“Vaccine development is rocket science. In order to go to Mars, one needs to use the mRNA and DNA technology,” says NK Arora, metaphorically explaining the significance of two indigenously developed vaccine platforms that pave the way for vaccine development and innovation in India.

Late last month, Gennova Biopharmaceuticals, a subsidiary of Emcure Pharmaceuticals, received an emergency use approval from the Indian drug regulator for its 2-dose, thermostable mRNA covid-19 vaccine. “Nobody in the world has come up with 2-8 degrees thermostable mRNA vaccine, which puts this vaccine in a very different league,” says Arora, Chairman of India’s Covid-19 Working Group of National Technical Advisory Group on Immunisation (NTAGI).

A first for India and third in the world, Gennova’s mRNA (messenger ribonucleic acid) vaccine GEMCOVAC-19 is next-generation technology having a thermostable quality – meaning, it can be stored and transported at 2-8 degrees Celsius without requiring refrigeration of (-)80 degrees Celsius as is required for the other mRNA vaccines.

What excites scientists and authorities is, the thermostable mRNA vaccine can be distributed in low and middle income countries without a logistical fuss, thereby ensuring equity in access to the vaccine for people in remotest areas.

Sanjay Singh, Gennova Chief Executive Officer, focussed on two problems - stability and cost control on raw material. “The US had its first mRNA vaccines from Pfizer and Moderna, requiring temperature of (-)70 degrees to keep the vaccine stable. It took us longer to come with our vaccine, because we tried to solve this problem and offered a thermostable vaccine.”

DNA & RNA

In human biology, the DNA (deoxyribonucleic acid) is inside the nucleus of a cell. The DNA makes RNA. This RNA copies the DNA message in the nucleus and takes it to cytoplasm, where protein synthesis happens - which triggers an antibody response.

An mRNA vaccine directly gets into the cytoplasm and starts protein synthesis. Scientists find it easier, faster and an effective mode of generating antibody response. The DNA vaccine may fall short in efficacy against an mRNA vaccine. G Padmanabhan, senior biochemist and former director at Indian Institute of Science (IISc) believes that because the DNA has to get to the nucleus to make RNA, unlike an mRNA vaccine where the RNA directly goes to the cytoplasm and makes the protein, the latter holds more promise than the former.

Further, a DNA vaccine isn’t entirely new and existed for animal use. But as a human vaccine, in August 2021, Zydus Lifesciences received the regulatory nod for the world’s first plasmid DNA Covid-19 vaccine - for administration in adult population in three doses. The platform utilises nucleic acid as active ingredient.

“The major expertise required for development of plasmid DNA vaccine is developing a suitable construct which can enter the cell, process development and scale up for manufacturing and selection of suitable delivery device,” a Zydus spokesperson said adding that in case of emergence of new mutants, this plug-and-play technology can develop new constructs to be achieved rapidly in few weeks.

‘De novo developer’

The company may have missed the commercial advantage due to a late roll out of its Covid-19 vaccine, but is confident of addressing several unmet healthcare needs using this platform. “Having worked on this technology, we may explore its application in therapeutics vaccines and in gene therapy,” it said.

These vaccine innovations, Arora believes, has strengthened the confidence of Indian academicians, researchers and industry to make “our own vaccine.”

The platforms have ignited hope for vaccines against HIV, Hepatitis-C virus, malaria and Human papillomavirus (HPV). Research is on for malaria (parasite) vaccine using mRNA technology. In case of a new pandemic, as soon as genome sequencing is made available, a new vaccine can be developed within weeks, and then put to clinical trials.

Arora says the ecosystem has been built where India has moved from “vaccine contract-manufacturer to De novo vaccine developer.”

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