Pune-based Gennova Biopharmaceuticals is in discussion with the central government on pricing and procurement of its mRNA technology-based Covid vaccine, which was approved for emergency use earlier this week, people familiar with the matter said on Wednesday.
“The discussions are currently on over pricing etc. and also the deployment strategy will be decided based on what NTAGI (National Technical Advisory Group on Immunisation) recommends,” said a senior central government official, requesting anonymity.
The vaccine, Gemcovac-19, is India’s first mRNA vaccine and only the third in the world to have received some form of authorisation for use during the pandemic.
Company executives too confirmed they were in talks with the government. “I would not like to put a timeline to it but we should hear from the government soon on this as we are in active discussions. We would then know whether government will procure from us or we will be allowed to individually reach out to private players,” said Samit Mehta, chief operating officer, Gennova Biopharmaceuticals, adding that the company was ready with 7 million tested and approved vaccine doses to be rolled out at short notice.
“The 7 million doses have been tested by the government lab in Kasauli (CDL) and ready to be rolled out,” said Mehta during a press briefing on Wednesday. As for the pricing, Mehta said even though it has not been decided as yet, still it would be very competitive as compared to the peers (other mRNA vaccines).
The company, which is a subsidiary of Emcure Pharmaceuticals Ltd, has an annual production capacity of 200 million doses.
Since a majority of the population is now vaccinated against Covid-19, the company is eyeing the booster dose segment, paediatric dose, and global supplies, for which it has begun preparations. The centres where the additional clinical trials will be conducted across the country have also been identified, according to the company spokesperson.
The company has already submitted trial protocol for the booster dose of GEMCOVAC-19 with other vaccines, and also plans to conduct trials in the paediatric population parallel. “The subject expert committee will review and guide us through the process. For booster we have a candidate ready that is tweaked to address the Omicron variant,” said Mehta.
The company hasn’t made its phase 2/3 trial data public yet even though it is in the process of getting it published.
In a statement on Wednesday, the company said, “GEMCOVAC™-19 has reached the primary end point of the Phase III clinical trial. The clinical data was evaluated by the Central Drugs Standard Control Organisation (CDSCO). The vaccine was found to be safe, well-tolerated and immunogenic.”
The company is also looking to supply to countries in Latin America and South East Asia, he said, adding that it is in discussions with 25-30 countries through parent Emcure’s network.
The company said there was no major adverse events observed in at least 4,000 healthy adult volunteers who took part in clinical trials across stages.
“Adverse events were not severe enough to draw attention. Most were self-resolved. There were no cases of myocarditis or any other cardiac issues in any of the volunteers,” said Mehta.
Unlike other mRNA vaccines such as the ones developed by Moderna and Pfizer that need to be stored at sub-zero temperatures, Gennova’s vaccine remains stable in 2-8 degrees Celsius, which is an added advantage from the storage point of view, especially in rural areas and developing countries where logistics can be an issue.
The company applied for emergency use authorization in March, this year.