Pune-based Gennova Biopharmaceuticals Limited has received approval from the Central Drugs Standard Control Organization (CDSCO) for conducting a clinical trial of its mRNA vaccine, Gemcovac-19, against the Omicron variant of COVID19.
“The Central Licencing Authority hereby permits Gennova Biopharmaceuticals Limited to conduct clinical trial of the new drug or investigational new drug as per protocol,” Drug Controller General of India, VG Somani, while granting the permission to the company, said.
The DCGI has also said that merely granting the permission to conduct clinical trial with the vaccine does not convey that, based on the clinical trial data generated with the vaccine, permission to market this vaccine in the country will automatically be granted to the company.
The mRNA vaccine of Gennova will have Omicron variant sub-lineage BA.1 as an ingredient and will be tested for active immunization against COVID-19 caused by the Omicron variant.
Gennova will be conducting the clinical trials for the variant vaccine on 10 different sites, CDSCO added.
"The formulation intended to be used in the clinical trial shall be manufactured under GMP conditions using validated procedures and shall have ongoing stability programme," the DCGI has told company.
The company has been told that only CDL, Kasauli certified batches shall be used in the clinical trial.
"A variant specific vaccine is being worked upon after looking at the prospect of mutations of COVID19. Currently, the existing vaccines have provided the protection, but this mRNA vaccine can be an important tool for countering the new variant of concern, which may emerge in future," Dr. NK Arora, chairman of the covid-19 working group of the National Technical Advisory Group on Immunization (NTAGI), told Moneycontrol.
He further said that the mRNA vaccine after the completion of trial and publication of data may be included in the vaccination program as booster doses.
"Once the study is completed, the mRNA may well be included in vaccination program as booster dose," he added.
Meanwhile, a highly placed source in Health Ministry said that Gennova is in last leg of pricing negotiations with the union government for its mRNA COVID19 vaccine Gemcovac-19.
Gemcovac-19 despite a nod from DCGI has not yet been included in the vaccination program for COVID19 in India.
While Gennova is facing a lawsuit in a Seattle court by a US start-up, but the company executive said there won't be any impact on the mRNA vaccine rollout plan.
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