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Monday, 17 January 2022

Pune-based Gennova Biopharmaceuticals developing vaccine for Omicron: Why this could be a game changer for India

As Omicron rages across India, causing a spike in COVID-19 cases, Pune's Gennova Biopharmaceuticals is developing an Omicron-specific vaccine.

The company, according to a spokesperson, has already filed its phase 2 data with Central Drugs Standard Control Organisation (CDSCO). "Gennova Biopharmaceuticals had filed its phase 2 data with CDSCO on Friday. The Omicron specific variant of vaccine is under development and will be ready for human clinical trials, subject to regulatory approvals," news agency ANI quoted the spokesperson of Gennova Biopharmaceuticals as saying.

Here’s what we know so far about this new vaccine.

The new vaccine is an mRNA vaccine in which a small part of the virus’s genetic code (RNA) is injected into a person to stimulate the recipient’s immune response. It contains instructions for human cells to make proteins that mimic part of the novel coronavirus, spurring the immune system into action. No actual virus is contained in the vaccines.

According to Gennova, the vaccine — HGCO19 — was found to be “safe, tolerable and immunogenic” by the CDSCO after the firm submitted interim clinical data of the phase I study.

The company is carrying out trials across 10-15 sites in Phase II and 22-27 sites in Phase III. Gennova is using the DBT-ICMR clinical trial network sites for this study.

News agency Reuters reported that Gennova Biopharmaceuticals’s Omicron-specific COVID-19 vaccine candidate could be ready in a month or two.

The development of this vaccine is a significant achievement for the country, Dr VK Paul, COVID-19 task force chief was quoted by Times of India as saying.

Paul said that the thermos-stable vaccine, using the existing cold-chain infrastructure, and the platform could be useful beyond COVID too.

Will this vaccine be effective against Omicron?

According to Medical News Today, a UK website for medical information, a study by researchers at the Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard showed that two doses of mRNA (Pfizer-BioNTech or Moderna) or one dose of viral vector (Johnson & Johnson) COVID-19 vaccines were insufficient to produce adequate immunity to a lab-created Omicron variant.

The Omicron pseudovirus infected cells at a higher rate than other pseudovirus variants. The results demonstrated a booster dose of an mRNA COVID-19 vaccine provided the best immune protection from the Omicron variant.

Pfizer also working on an Omicron vaccine

In early January, Pfizer CEO Albert Bourla said a vaccine that targets the Omicron variant of COVID-19 would be ready in March, and the company had already begun manufacturing the doses.

Bourla said the vaccine would also target the other variants that are circulating.

With inputs from agencies

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