According to reports, Biological E has submitted an application to India’s medicines authority requesting emergency use authorization for its Covid vaccine Corbevax as a booster dose in people fully vaccinated with Covishield or Covaxin. Corbevax, India’s first indigenously manufactured RBD protein subunit vaccine, has already been licensed for limited use in emergency settings for persons aged five and up by the Drugs Controller General of India (DCGI). It is now being used to immunize youngsters aged 12 to 14 years old.
According to the EUA application submitted to DCGI, Biological E assessed the safety and immunogenicity of Corbevax as a single-dose booster in Covid-negative people fully vaccinated with either Covishield or Covaxin in a phase-3 placebo-controlled clinical research based on the drug regulator’s approval. The trial included 416 participants aged 18 to 80 who were vaccinated with two doses of either Covaxin or Covishield, with the last vaccine provided at least six months before receiving the booster dose of Corbevax.
‘The results demonstrated a substantial increase in immunogenicity in terms of neutralizing antibodies after 28 days in both Covishield and Covaxin arms as compared to the placebo cohort. Corbevax’s safety profile was determined to be comparable to that of previous clinical studies ‘, according to an official source, the Hyderabad-based business listed in the EUA application.
‘We are now submitting the marketing authorization application for the grant of permission Corbevax for restricted use in an emergency situation as a booster dose six months after completion of primary immunization with two doses of Covishield or Covaxin in individuals aged 18 years and above,’ the company stated.
As of present, the prophylactic dosage is the same COVID-19 vaccination used for the first and second doses. From January 10, India began distributing precautionary doses of Covid vaccines to healthcare and frontline workers, as well as people aged 60 and up with comorbidities.
The comorbidity provision was eliminated in March, making all adults over the age of 60 eligible for the prophylactic dosage of Covid vaccination. On April 10, India began delivering COVID-19 vaccine prophylactic doses to all adults over the age of 18 at private vaccination centres. All persons above the age of 18 who have completed nine months after the second dosage are eligible for the prophylactic dose.