Corbevax heterologous COVID-19 booster is anticipated to receive final government clearance soon: Sources

According to reports, the Union administration is contemplating providing final permission to the Corbevax heterologous COVID-19 booster for ‘Restricted Use in Emergency Situation’ soon. The National Technical Advisory Group on Immunisation (NTAGI) endorsed Biological E’s Corbevax as a heterologous booster for adults in the month of July.

Previously, Biological E’s Corbevax got DCGI clearance for a heterologous COVID-19 booster injection for Restricted Use in Emergency Situations on June 4, 2022. It is India’s first vaccination to receive DCGI clearance for a heterologous COVID-19 booster dose.

Biological E Limited (BE), a Hyderabad-based pharmaceutical and vaccine company, announced that the Drug Controller General of India (DCGI) has approved its Corbevax COVID-19 vaccine as a heterologous COVID-19 booster dose for individuals aged 18 years and above after 6 months of administration of primary vaccination (two doses) of Covaxin or Covishield vaccines for restricted use in emergency situations.

Corbevax Vaccine to be Licenced as a Heterologous COVID-19 Booster

“BE’s Corbevax vaccine is the first in India to be licenced as a heterologous COVID-19 booster.” BE recently provided its clinical trial data and submitted it to the DCGI, which granted their approval for administering Corbevax vaccine as a heterologous booster dose to people who have already taken two doses of either Covishield or Covaxin after a detailed evaluation and deliberation with Subject Experts Committee (SEC),” according to a statement from Biological E.

“BE’s clinical trial data demonstrated that the Corbevax booster dosage offered a significant augmentation in immune response as well as the good safety profile necessary for a successful booster,” the company stated.

“We are extremely thrilled with this clearance, which will meet the demand for COVID-19 booster dosages in India,” stated Mahima Datla, Managing Director of Biological E Limited. We’ve reached a new milestone in our COVID-19 immunisation journey. This clearance supports Corbevax’s continued world-class safety standards and high immunogenicity.”

“BE conducted a multicenter Phase III placebo-controlled heterologous booster clinical trial in 416 subjects aged 18 to 80 who had previously received two doses of either Covishield or Covaxin at least 6 months prior to the administration of Corbevax as a booster dose,” Biological E stated in a statement.

“The booster dose of Corbevax significantly enhanced neutralising antibody titers in the Covishield and Covaxin groups as compared to placebo,” it stated.

Meanwhile, according to the Ministry of Health and Family Welfare, India registered a total of 12,751 new COVID-19 cases in the previous 24 hours, bringing the overall number of infections to 4,41,74,650.

The death toll from Covid has risen to 5,26,772 with 42 more fatalities.

India presently has 1,31,807 active cases, accounting for 0.31 percent of all cases.

Also Read: To prevent future COVID-19 outbreaks, universal immunisation is required: Research

The current recovery rate is 98.50 percent. In the previous 24 hours, 16,412 recoveries from the virus were recorded, bringing the overall number of recoveries to 4,35,16,071.

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