Gennova Biopharmaceuticals is awaiting approval of its Gemcovac-19 vaccine for restricted emergency use in adults.
Gennova Biopharmaceuticals Ltd on Wednesday said it is ready with 70 lakh dosages of its Gemcovac-19 vaccine, the first indigenously developed mRNA vaccine against Covid-19 to be approved for restricted emergency use in adults. The company, which is a subsidiary of Emcure Pharmaceuticals Ltd, has an annual capacity of producing 200 million dosages of the vaccine and is awaiting the government's nod to roll it out in the market.
Gemcovac-19 received Emergency Use Authorization (EUA) from the Drugs Controller General of India (DCGI) on Tuesday. Addressing a virtual press conference, Gennova Biopharmaceuticals Ltd, Chief Operating Officer Samit Mehta said Gemcovac-19 is the first mRNA vaccine developed in India and the only third mRNA vaccine to be approved for Covid-19 in the world.
In contrast to other mRNA vaccines that require to be stored at sub-zero temperatures, Gemcovac-19 can be stored at 2-8 degrees. That makes it "unique in its deployability in countries like India" and other similar nations, Mehta said, highlighting the advantages of Gemcovac-19 in terms of logistics and transportation.
Gemcovac-19 will be available for adults above 18 years of age. It is a two-dose vaccine to be administered intramuscularly with a gap of 28 days. When asked about the company's ability to supply the vaccine, he said, depending on the government's stand, Gennova has "seven million (70 lakh) dosages ready for immediate supplies".
The company said it aims to produce around 40-50 lakhs of doses per month and the capacity can be quickly doubled. Mehta said that Gennova has an annual capacity to produce 200 million formulation dosages. As for the Active Pharmaceutical Ingredient (API) of the vaccine, it has the capacity to produce 500 million dosages annually and the plan is to double it to 1 billion dosages this year. On the market rollout of Gemcovac-19, he said, it would depend on what stand the government takes, either for its procurement or to make it available in the private market.
Commenting on the pricing of the vaccine, Mehta said, "It has not been fixed. There is still an ongoing discussion with the government." However, he said, it would be "competitive" as compared to the other two mRNA vaccines of Moderna and Pfizer. In India, he said, as per the emergency use authorization Gemcovac-19 will be used for adults who have not been vaccinated against Covid-19 so far.
The company, however, is planning to seek approval for using its vaccine for booster dose and trials will be conducted for mix-and-match with other Covid-19 vaccines. Also, it will target pediatric usage parallelly. On the safety of the vaccine, he said, there were "no adverse events" in over 4,000 adult volunteers who took part in clinical trials across stages.
Gennova said its Covid-19 vaccine has reached the primary endpoint of Phase III clinical trial. The clinical data were evaluated by the Central Drugs Standard Control Organisation (CDSCO). The vaccine was found to be safe, well-tolerated, and immunogenic. Mehta further said that WHO prequalification for supplying Gemcovac-19 to the global health organization would be the next step for the company.
The company is looking to supply to countries in Latin America and southeast Asia, he said, adding that it is in discussions with 25-30 countries through parent Emcure's network. The exports of Gemcovac-19 could also be through the Indian government's supplies to other countries as part of vaccine diplomacy and supplies to WHO, Mehta said.
"Beyond India, Gennova aims at providing sustainable access to low-and middle-income countries around the world to the vaccine to blunt the spread of the pandemic," the company said.