For the first time ever, the organic E’s Corbevax was approved by the Drug Control General on Saturday India (DGCI) as an asymptomatic COVID-19 booster dose for adults. Individuals 18 years of age and older can now be administered Corbevax as a booster dose six months after the primary vaccination (two doses) of Covaxin or CoviShield vaccines.
The Corbevax vaccine was approved by the DCGI last December and has also been approved for testing a booster dose. In April this year, the drug regulator approved the vaccine for children aged 5-12 years. Corbevax was already being used to vaccinate 12-14 year olds.
Corbevax, India’s indigenously developed receptor binding domain (RBD) or protein sub-unit vaccine against COVID-19, uses a similar technology that has been used for decades to make hepatitis B vaccines Is. The vaccine is administered via the intramuscular route in two-dose prescribed 28 days apart.
Mahima Datla, Managing Director, Biologicals E Ltd, said in a statement, “We are extremely pleased with this approval, which will meet the requirement of COVID-19 booster doses in India. We have crossed another milestone in our COVID-19 vaccination journey. This approval once again demonstrates the world-class safety standards and high immunogenicity of Corbevax.”
on the part of booster test, included participants between or equal to 18 and 80 years of age and six months before the last dose of the primary vaccine was received. A total of 360 subjects were enrolled in one of two groups for safety and immunogenicity assessment.
All participants received a 0.5 ml single dose of Corbevax intramuscularly. Participants were followed up for 28 days for any safety issues.
The phase-3 clinical study primarily evaluated the immune response and safety of the single-dose Corbevax vaccine for booster protection against Covid-19, as per the protocol approved by the DCGI. News18.com,
In May, Biologicals E reduced the price of each dose of Corbevax from Rs 840 to Rs 250 at private immunization centres. A single dose of vaccine at a vaccination center now costs Rs 400, which includes taxes and administration charges.
Corbevax is entirely developed and manufactured by BE Limited in association with Texas Children’s Hospital and Baylor College of Medicine. BE has so far supplied 10 crore doses of jab to the central government.
(with PTI inputs)
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