Biological E seeks EUA for Corbevax as booster in adults vaccinated with Covishield, Covaxin

Biological E has submitted an application to Indias drug regulator seeking emergency use authorisation for its Covid vaccine Corbevax as a booster dose in adults fully vaccinated with Covishield or Covaxin sources said on WednesdayThe Drugs Controller General Of India DCGI had already approved Corbevax Indias first indigenously developed RBD protein subunit vaccine for restricted use in emergency situations for those aged five and aboveCurrently it is being used to inoculate children in the age group of 12 to 14 yearsAccording to the EUA application submitted to DCGI Biological E in a phase3 placebocontrolled clinical study based on the drug regulators nod has evaluated the safety and immunogenicity of Corbevax as a singledose booster in Covidnegative adults fully vaccinated with either Covishield or CovaxinThe study was conducted on 416 subjects aged 18 to 80 who were vaccinated with two doses of either Covaxin or Covishield with the last jab administered at least six months prior to giving the booster dose of CorbevaxThe results showed a significant boost in immunogenicity in terms of neutralizing antibodies after 28 days when compared with placebo cohort in both Covishield and Covaxin armsThe safety profile of Corbevax was found similar to that of the earlier clinical trials an official source told PTI quoting the Hyderabadbased firm as having mentioned in the EUA applicationThe firm said We are now submitting the marketing authorization application for grant of permission Corbevax for restricted use in an emergency situation as a booster dose at six months after completion of primary immunization with two doses of Covishield or Covaxin in individuals aged 18 years and aboveAs of now the precaution dose is of the same Covid19 vaccine used for administering the first and second dosesIndia began administering precaution doses of Covid vaccines to healthcare and frontline workers and those aged 60 and above with comorbidities from January 10The comorbidity clause was removed in March making all people aged above 60 years eligible for the precaution dose of Covid vaccineIndia on April 10 began administering precaution doses of Covid19 vaccines to all aged above 18 years at private vaccination centresAll those above the age of 18 who have completed nine months after the administration of the second dose are eligible for the precaution doseThis story has been sourced from a third party syndicated feed agencies Midday accepts no responsibility or liability for its dependability trustworthiness reliability and data of the text Midday managementmiddaycom reserves the sole right to alter delete or remove without notice the content in its absolute discretion for any reason whatsoeverThis story has been sourced from a third party syndicated feed agencies Midday accepts no responsibility or liability for its dependability trustworthiness reliability and data of the text Midday managementmiddaycom reserves the sole right to alter delete or remove without notice the content in its absolute discretion for any reason whatsoever