Biological E Limited on Saturday introduced that its COVID-19 vaccine Corbevax has been accredited by the Drug Controller General of India (DCGI) as a heterologous booster dose.
A press launch from the vaccine maker mentioned the Corbevax could be administered as a booster dose to people aged 18 years and above after six months of administration of main vaccination (two doses) of Covaxin or Covishield vaccines for restricted use in emergency scenario.
BE’s Corbevax is the primary such vaccine in India to be accredited as a heterologous COVID-19 booster within the nation, it mentioned.
Recently, BE furnished its medical trials information to the DCGI which after an in depth analysis and deliberations with Subject Experts Committee, granted their approval for administering Corbevax as a heterologous booster dose to individuals who have been vaccinated.
BE’s medical trial information confirmed that its Corbevax booster dose offered important enhancement in immune response and glorious security profile required for an efficient booster.
Mahima Datla, Managing Director, Biological E Limited, mentioned, “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.” BE has performed a multi-centre Phase-III placebo managed heterologous booster medical trial in 416 topics from 18 to 80 years of age who have been beforehand vaccinated with two doses of both Covishield or Covaxin not less than six months previous to the administration of Corbevax as a booster, the discharge added.
Corbevax is completely developed and manufactured by BE Limited in affiliation with Texas Children’s Hospital and Baylor College of Medicine as a recombinant protein sub-unit vaccine towards COVID-19.
BE has equipped 100 million doses of the jab to the Central authorities to this point.
Source: www.financialexpress.com”