India's first mRNA Covid vaccine will be priced competitively, says company

Gemcovac does not require sub-zero temperatures for storage and transport, unlike two other international doses

India’s first mRNA Covid-19 vaccine Gemcovac-19 will be priced competitively with its global peers — Pfizer-BioNTech and Moderna’s vaccines, Gen¬nova Biophar-maceuticals said. Trials for use as a universal booster shot would also begin soon, and there are plans to conduct paediatric trials as well.

The vaccine’s unique selling point is that it does not require sub-zero temperatures like its peers to remain stable, but can be transported at 2-8 degrees Celsius. The vaccine can be rolled out in the private market with necessary government approvals, while Gen¬nova continues to work on trials for positioning Gemc¬ovac-19 as the universal booster. So far, India has not allowed heterologous boosting of vaccines.

Samit Mehta, chief operating officer, Gennova Biopharmaceuticals said that while no final decision has been taken on pricing, it would be priced very competitively with its global mRNA peers. Pfizer-BioNTech's mRNA vaccine sells for $19.5 a dose in the US while Moderna's shot is priced at $25 a dose.

Meanwhile, Pune based Gennova is also gearing up to double its vaccine manufacturing capacity from a current 180-200 mn doses a year to 400 mn doses in the next four to five months. Mehta said that they are working to double their bulk production capacity to 1 bn annual doses too. Gennova’s parent Emcure Pharmaceuticals had spare injectables capacity where the company is currently manufacturing the vaccine.

Mehta said that Emcure also has lyophilisation capacities (freeze drying) which is essential for making this vaccine. Mehta said that the discussions arou¬nd pricing the vaccine are on, but it would be priced competitively with its global mRNA peers. The vaccine received the emergency use authorization from the Drugs Controller General of India (DCGI) recently, and the company is now gearing up for a launch provided the necessary government approvals come through.

Mehta said that they have a stockpile of 7 mn doses of their mRNA vaccine which are also approved by the Central Drugs Laboratory, Kasauli. He added that they have a capacity to make 12-15 mn doses a month now at their plants.

“We have developed a version of the vaccine specifically for the Omicron variant. This is the version we will now test as the universal booster after Covishield and Covaxin – the two widely used vaccines in India,” Mehta said, adding that they have already submitted trial protocols with the Central Drugs Standards Organisation (CDSCO).

The addressable market for Gemcovac-19 will be booster doses as more than 95 percent of India has already been vaccinated. The company is eying two more avenues – overseas markets and also supplies to the World Health Organisation (WHO). Gennova has plans to apply for WHO prequalification.

Mehta said that they are actively in discussion with 25-30 emerging markets and that one of the Latin American nations is close to granting an emergency use authorization to their mRNA vaccine.

The firm claimed that since this vaccine is given in lower doses, and induces the same efficacy, the instances of adverse side effects were few and self-resolving during the trials. They see global demand for their vaccine as it remains stable at 2-8 degree Celsius making the supply chain management relatively easier.

With the first mRNA vaccine on the block, Gennova now plans to develop several vaccines using this platform – tuberculosis, herpes zoster etc. “We are pursuing the paediatric trials project for Gemcovac-19 simultaneously along with the Omicron version. The other candidates are in pre-clinical stages and would soon go into the clinic,” Mehta told reporters here.