According to official sources, an Indian pharmaceutical company has produced an Omicron variant-specific COVID-19 vaccination that would be tested on people in the near future.
Gennova Biopharmaceuticals has also submitted phase 2 data for its original mRNA vaccine candidate and has completed the phase 3 trial enrollment process, according to reports. Last year, the government announced that the vaccine candidate had been proven to be “safe, tolerable, and immunogenic” in trial participants.
“Pune-based Gennova Biopharmaceuticals has submitted phase 2 data of mRNA vaccine and has also completed the recruitment of phase 3 data. Drugs Controller General of India’s (DCGI) Subject Expert Committee (SEC) is expected to review the data soon,” official sources were reported as saying by ANI.
The sources added that the mRNA vaccine developed by Gennova Biopharmaceuticals for the Omicron variant will be tested on humans for efficacy and immunogenicity soon.
Separately, international news agency Reuters reported that Gennova Biopharmaceuticals’s Omicron-specific COVID-19 vaccine candidate could be ready in a month or two.
A source said on the condition of anonymity that the product is likely to undergo a small trial in the country before it could be made available as a booster or standalone vaccine.
Gennova is a unit of drugmaker Emcure Pharmaceuticals which has a presence in some 70 countries.
Pfizer Inc, which has also developed an mRNA vaccine for the COVID-19 disease, has said that it is likely to introduce its redesigned vaccine that specifically targets the Omicron variant by March.
If Gennova’s original vaccine candidate gets emergency-use approval, it would become India’s first mRNA COVID-19 vaccine similar to the ones developed by Pfizer and Moderna.