According to the EUA application submitted to DCGI, Biological E in a phase-3 placebo-controlled clinical study has evaluated the safety and immunogenicity of Corbevax as a single-dose booster in Covid-negative adults vaccinated with Covishield or Covaxin.
The company conducted the study on 416 subjects aged 18 to 80 who took the second jab at least six month ago.
"The 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 arms. The safety profile of Corbevax was found similar to that of the earlier clinical trials," PTI quoted a source from the firm as saying.
“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 above," it added.
Currently, the precaution dose being given is of the same Covid-19 vaccine used for administering the first and second doses.
This comes days after the Drugs Controller General Of India (DCGI) approved Corbevax, India's first indigenously developed RBD protein subunit vaccine, for restricted use in emergency situations for those aged five and above.
India's booster dose programme
India began administering precaution doses of Covid vaccines to healthcare and frontline workers and those aged 60 and above with comorbidities from 10 January.
The comorbidity clause was removed in March, making all people aged above 60 years eligible for the precaution dose of Covid vaccine.
On 10 April, the country began administering precaution doses of Covid-19 vaccines to all aged above 18 years at private vaccination centres.
All those above the age of 18 who have completed nine months after the administration of the second dose are eligible for the precaution dose.
With inputs from agencies.
