The Drug Controller General of India (DCGI) has recently approved Pune-based Gennova Biopharmaceuticals’ two-dose mRNA COVID-19 vaccine ‘GEMCOVAC-19’ for emergency use in adults aged 18 years and above. It is expected to be available soon in the country. However, the homegrown vaccine is likely to see low penetration in the Indian market, says GlobalData, a leading data and analytics company.

According to GlobalData’s ‘Pharmaceutical Intelligence Center’, India has so far administered more than 1.98 billion COVID-19 vaccine doses (as of 07 July 2022).

According to the government’s web portal, ‘CoWIN’, 93% of the eligible population (12 years and above) in India received at least one dose of the COVID-19 vaccination, while 83% of the eligible population are fully vaccinated as of 07 July 2022. In contrast, penetration for the precautionary dose (terminology used for a booster dose in India) is significantly low at <5%.

Neha Myneni, Pharma Analyst at GlobalData, comments: “While the majority of India’s eligible population have completed their initial dosing of the COVID-19 vaccines, the mRNA platform is likely to be an option in the medium to long-term as a booster dose. GEMCOVAC-19 has currently not received approval for use as a booster dose in India. Hence, GlobalData expects low market penetration as the proportion of the eligible population yet to receive a COVID-19 vaccine is comparatively small.”

GEMCOVAC-19 is the third mRNA vaccine option worldwide for COVID-19, though only approved in India. The leading mRNA vaccines are Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax. However, in India, Moderna’s Spikevax is the only approved mRNA vaccine alternative for COVID-19, however it is not yet available for use.

GlobalData learns that The National Technical Advisory Group on Immunization (NTAGI) could consider GEMCOVAC-19 for inclusion in India’s ongoing national program for COVID-19 vaccination, which signals its possible market launch soon.

Myneni continues: “GEMCOVAC-19’s approval surely paves the way for further development of homegrown mRNA vaccines for other deadly diseases in India. However, its success post-launch will likely depend on the government’s decision to procure and deploy the vaccine, as the majority of the vaccinations in India are driven by the government (40,530 vaccination sites run by the government vs. 1,396 sites run by private institutions).”

Earlier cases like ZyCoV-D (the world’s first DNA-based COVID-19 vaccine) and Sputnik V did not receive as much success as anticipated in India due to the above reason (the market penetration of these two vaccines in India is <2%).

Myneni concludes: “With limited opportunity in India, particularly in adult patients who have not received their primary vaccine series, Gennova Biopharmaceuticals can aim for other lower and middle-income countries where COVID-19 vaccination rates are still low. In such cases, there may be unmet need for primary vaccination and GEMCOVAC-19 can emerge as the leading option, provided the vaccine’s clinical results are made available.”