Hindustan Times (Noida)

GENNOVA’S MRNA VACCINE GETS CLEARANCE FOR PHASE 2/3 CLINICAL TRIALS

- Rhythma Kaul letters@hindustant­imes.com

NEW DELHI: India’s first domestical­ly developed mrna-based Covid-19 vaccine candidate has been found safe in its interim Phase 1 clinical trials, and the national drugs regulator has granted approval to its maker, Pune-based Gennova Biopharmac­euticals, to begin Phase 2/3 trials, the Union ministry of science and technology said on Tuesday.

The developmen­t of HGCO19 is a key step in India’s target of vaccinatin­g all adults by the end of the year as senior government officials have said that — subject to trials and approval — they are targeting administra­tion of 60 million doses of this vaccine by the end of December.

“Vaccine Subject Expert Committee reviewed the interim Phase I data and found that HGCO19 was safe, tolerable, and immunogeni­c,” said ministry said in a statement.

NEW DELHI: India’s first domestical­ly developed mrna-based Covid-19 vaccine candidate has been found safe in its interim Phase 1 clinical trials, and the national drugs regulator has granted approval to its maker, Pune-based Gennova Biopharmac­euticals, to begin Phase 2/3 trials, the Union ministry of science and technology said on Tuesday.

The developmen­t of HGCO19, the country’s first vaccine based on messenger-rna (MRNA) technology, is a key step in India’s target of vaccinatin­g all adults by the end of the year as senior government officials have said that — subject to trials and approval — they are looking at availabili­ty of 60 million vaccine doses by December.

The candidate could join a club of mrna-based vaccines currently consisting of just two American vaccines – by Pfizerbion­tech and Moderna Inc – both of which have the highest efficacy among those currently being administer­ed globally.

“Gennova Biopharmac­euticals Ltd., the Pune-based biotechnol­ogy company, working on the nation’s first mrnabased Covid-19 vaccine, submitted the interim clinical data of the Phase I study to the Central Drugs Standard Control Organisati­on (CDSCO), the Government of India’s National Regulatory Authority (NRA). Vaccine Subject Expert Committee (SEC) reviewed the interim Phase I data and found that HGCO19 was safe, tolerable, and immunogeni­c in the participan­ts of the study,” science and technology ministry said in a statement issued on Tuesday.

The company began Phase 1 trial in April. HGCO19’S developmen­t is being supported by central government’s Department of Biotechnol­ogy-biotechnol­ogy Industry Research Assistance Council (DBT-BIRAC).

“It is a matter of great pride that Nation’s first mrna-based vaccine is found to be safe and the Drugs Controller General of India (DCGI) has approved Phase 2/3 trials. We are confident that this will be an important vaccine for both India and the world. This is an important milestone in our indigenous vaccine developmen­t mission and positions India on the global map for novel vaccine developmen­t,” said Renu Swarup, secretary, DBT, and chairperso­n,

BIRAC.

According to the company, the study will be conducted across the country at around 10-15 sites in Phase 2, and 22-27 sites in Phase 3. Gennova plans to use the Dbt-indian Council of Medical Research (ICMR) clinical trial network sites for this.

Swarup earlier said that DBT was hand-holding Gennova from the start, and had also provided seed funding for the developmen­t of HGCO19.

Gennova developed this vaccine candidate in collaborat­ion with HDT Biotech Corporatio­n, United States.

“After establishi­ng the safety of our mrna-based Covid-19 vaccine candidate HGCO19 in Phase 1 clinical trial, Gennova’s focus is to start Phase 2/3 pivotal clinical trial. In parallel, Gennova is investing in scaling up its manufactur­ing capacity to cater to the nation’s vaccine requiremen­t,” said Sanjay Singh, chief executive officer, Gennova Biopharmac­euticals Ltd.

Gennova submitted the proposed Phase 2 and Phase 3 study titled “A Prospectiv­e, Multicentr­e, Randomized, Active-controlled, Observer-blind, Phase II study seamlessly followed by a Phase III study to evaluate the safety, tolerabili­ty, and immunogeni­city of the candidate HGCO19 (Covid-19 vaccine) in healthy subjects” that was approved by the office of the DCGI, CDSCO.

THE CANDIDATE COULD JOIN A CLUB OF MRNA-BASED JABS CURRENTLY CONSISTING OF JUST 2 AMERICAN VACCINES

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