India’s first mRNA-based Omicron-specific booster vaccine approved

Pune-based Gennova Biopharmaceuticals on Tuesday announced that its mRNA COVID-19 booster vaccine, GEMCOVAC-OM, against the Omicron variant of SARS-CoV2 has received emergency use authorisation from the Drugs Controller General of India (DCGI). “A booster dose against SARS-CoV2 is still required in the country. Original vaccines have shown limited efficacy against the Omicron lineage. An updated vaccine is required and yes, we anticipate enough demand in the market for the precautionary dose,” said Dr Sanjay Singh, CEO of the Pune-based Gennova Biopharmaceuticals Ltd said today.

The launch is expected within two to three weeks in New Delhi where details on the cost and anticipated demand will be announced. At present, 12 lakh booster doses of GemCOVAC-OM are available at the Central Drugs Laboratory (CDL), Kasauli, which has the mandate of national regulations of vaccines produced indigenously for the domestic market.

The launch is expected within two to three weeks in New Delhi where details on the cost and anticipated demand will be announced

More than 220 crore doses of Covid vaccine have been administered in the country so far and according to official data till April this year, around 24 per cent of the fully vaccinated population in the country had received booster shots. Active cases of Covid are now 0.01 percent of total infections, according to the Union Ministry of Health and Welfare. With Covid lying low and a tepid uptake of boosters across the country, Dr Singh is unfazed by the volley of questions raised at a virtual media conference on the relevance of a booster dose in such a scenario. “GEMCOVAC-OM has demonstrated robust immune responses in phase 3 clinical trials conducted at 20 centres across 13 cities in India. In Phase-II/ III trials, approximately 3,000 individuals received GEMCOVAC-OM and the vaccine was safe and well tolerated. The currently approved vaccines used as precautionary/ booster doses are designed against the ancestral strain of SARS-CoV-2. Although these will increase the antibody titers, their ability to neutralise the circulating Omicron variant of SARS-CoV-2 is limited. Developing antibodies and memory immune responses specific to the Omicron variant would reduce the probability of infection and hospitalisation and prevent future waves of the pandemic. The Made-in-India GEMCOVAC-OM specifically addresses this gap,” he said.

“After US top biotech firms Moderna and Pfizer, we are the third company to develop an mRNA COVID-19 booster vaccine – the first in India – to do so against the highly transmissible Omicron variant,” Dr Singh added.

Those who are 18 years of age and older can take the vaccine as a booster dose. This can be administered safely to individuals who have received two doses of either Covaxin or Covishield. The vaccine is stable at 2-8 °C and is a lyophilized (freeze-dried) vaccine. It is delivered intradermally using a device called Tropis, developed by PharmaJet, USA . Almost a year ago, the country’s first homegrown mRNA Covid-19 vaccine developed at Pune’s biotech firm had received emergency use and while the Drug Controller General Of India had approved the two-dose mRNA vaccine, authorities at Gennova Biopharmaceuticals admitted that there was not much uptake. “Look, we were granted approval at a time when people had already been immunized with the existing vaccines,” the CEO said. “Of the 70 lakh doses produced at risk, several were used while some were wasted,” Dr Singh said.

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“There is a realisation that COVID-19 will remain and keep mutating, and, therefore, we need to be prepared with vaccines to deal with emerging variants. The mRNA platform, which was developed in association with the Department of Biotechnology, Government of India, provides an opportunity for a quick turnaround for vaccine development for any variants of concern in the future, if any,” he added. Samit Mehta, COO, of Gennova Biopharmaceuticals Limited, said: “Gennova has successfully developed India’s first Omicron-variant vaccine within a few months. Being aware of the accessibility challenges the world witnessed for the COVID-19 vaccines, we are happy that we are providing a vaccine based on state-of-the-art technology, the mRNA.”