The Drugs Controller General of India (DCGI) on June 4 approved Corbevax as a precaution dose for those aged 18 and above.
Corbevax has become the first Covid-19 vaccine in India to be approved by the DCGI as a heterologous Covid-19 booster dose.
Corbrvax is also offered in a single-dose vial, making it more convenient for vaccine administration. It eliminates vaccine wastage, which is a major advantage for private hospitals.
The Drugs Controller General of India (DCGI) has also granted emergency use authorisation (EUA) to Cadila for its ZyCoV-D for an additional dose of 3mg with a two-jab inoculation schedule 28 days apart for those aged above 12 years.
India began administering precaution doses of vaccines to healthcare and frontline workers and those aged 60 and above with comorbidities from January 10.
As India began vaccinating children of 12 to 14 age group from Wednesday morning, Prime Minister Narendra Modi tweeted, "Today is an important day in India's efforts to vaccinate our citizens. Now onwards, youngsters in the 12-14 age group are eligible for vaccines and all those above 60 are eligible for precaution doses. I urge people in these age groups to get vaccinated".
Corbevax is India's third indigenous Covid-19 vaccine after Covaxin and Zydus Cadila's ZyCoV-D vaccine.
The Corbevax vaccine is administered through intramuscular route with two doses, scheduled 28 days apart, and is stored at 2 to 8 degrees Celsius temperature and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial and 10 mL (20 doses) vial pack.
In an application sent to the DCGI on February 9, Srinivas Kosaraju, the head of Quality and Regulatory Affairs of Biological E Limited said the firm had received approval for conducting phase 2/3 clinical study of Corbevax among children and adolescents aged 5-18 years in September.
India's Drug Regulator approved India's first indigenously developed RBD protein sub-unit vaccine against COVID-19, Corbevax, for restricted use in emergency situation.
The recombinant protein sub-unit vaccine developed from the RB) of the spike protein on the viral surface is adjuvanted with Dynavax's CpG 1018 and alum. Comprehensive Phase 3 clinical trials involving more than 3,000 subjects between the ages of 18 and 80 at 33 study sites across India, demonstrated the vaccine to be safe, well tolerated and highly immunogenic.
"This announcement is an important first step in vaccinating the world and halting the pandemic. Our vaccine technology offers a path to address an unfolding humanitarian crisis, namely the vulnerability the low- and middle-income countries face against the delta variant, Hotez said.
The Hyderabad-based company, Biological E said these capacities will enable it to deliver 300 million doses as promised to the Government of India. Soon, the company plans to deliver more than one billion additional doses globally.
All the recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.
Biological E, the Hyderabad-based vaccine maker, expects the rollout of its Covid-19 vaccine 'Corbevax' by the end of November and is looking to supply nearly 10 crore doses on the day of its launch
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