Indian vaccine manufacturer Biological E has received approval from the Drugs Controller General of India (DCGI) for its Covid-19 vaccine Corbevax as a heterologous booster dose for people aged 18 years and above.
Corbevax is a protein sub-unit Covid-19 vaccine, which has been developed from a component of the spike protein on the virus’s surface that helps to develop immune response against the virus.
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It has the receptor binding domain (RBD) protein as an antigen, aluminium hydroxide and CpG 1018 as adjuvants formulated in Tris buffer.
The vaccine has been approved for restricted use during emergency and will be given after six months of the first two doses of either Covaxin or Covishield vaccines.
Biological E managing director Mahima Datla said: “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.”
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By GlobalDataThe company stated that the regulatory approval for the vaccine was based on data obtained from a multicentre Phase III placebo controlled heterologous booster clinical trial.
The study was conducted in 416 participants aged 18 to 80 years who were previously vaccinated with first two doses of Covaxin or Covishield.
Findings from the trial showed that Corbevax increased the neutralising antibody titers in the Covishield and Covaxin groups compared to placebo group.
As indicated by cytokine expression analysis, the booster dose also demonstrated significant Th1 skewed cellular immune response after stimulation of the T-cells.
Biological E stated that the booster vaccine was safe and well tolerated, and no severe or adverse events were reported for three months after the booster dose was given.
