In a first, Biological E’s Corbevax was on Saturday cleared by the Drug Control General of India (DGCI) as a heterologous Covid-19 booster dose for adults. Corbevax can now be administered as a booster dose to individuals aged 18 years and above after six months of administration of primary vaccination (two doses) of Covaxin or Covishield vaccines.
The Corbevax vaccine was approved by the DCGI last December and the nod for conducting trials of booster doses was also given. In April this year, the drug regulator approved the vaccine for children aged 5-12 years. Corbevax was already being used to vaccinate children in the age group 12-14 years.
Corbevax, which is India’s indigenously developed Receptor Binding Domain (RBD) or protein sub-unit vaccine against Covid-19, uses similar technology that has been used for decades to make hepatitis B vaccines. The vaccine is administered through an intramuscular route with a two-dose scheduled 28 days apart.
Mahima Datla, Managing Director, Biological E Limited, said in a statement, “We are very happy with this approval, which will address the need for Covid-19 booster doses in India. We have crossed yet another milestone in our Covid-19 vaccination journey. This approval reflects once again the sustained world-class safety standards and high immunogenicity of Corbevax.”
As part of its booster trial, participants between or equal to 18 to 80 years of age were included and took the last dose of the primary vaccine six months ago. A total of 360 subjects were enrolled on one of the two groups for safety and immunogenicity assessment.
All participants received a 0.5 ml single dose of Corbevax intramuscularly. The participants were followed up for a period of 28 days for any safety issues.
The phase-3 clinical study primarily evaluated the immune response and safety of a single-dose Corbevax vaccine for booster protection against Covid-19, according to the approved protocol by the DCGI accessed by News18.com.
In May, Biological E slashed the price of each dose of Corbevax to Rs 250 from Rs 840 at private vaccination centres. One dose of the vaccine at a vaccination centre now costs Rs 400, including the 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 supplied 100 million doses of the jab to the Central government so far.
(With PTI inputs)
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