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Biological E seeks approval of Corbevax as booster for Covishield, Covaxin recipients

By Livemint
This comes days after the DCGI approved Corbevax for restricted use in emergency situations for those aged five and above (AFP)

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. 

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Dive Deeper:
Mix and match of Covid-19 vaccine for booster shots unlikely to be allowed: Report
As of now, mixing of Covid-19 vaccines is not allowed in the country, which means the precaution dose is of the…
Citizens, students going abroad can take booster shot of COVID vaccine, says Mandaviya
NTAGI has recommended that these people can take precautionary dose before stipulated nine-month waiting period
Centre to allow precaution dose before 9-month waiting period but there's a catch
An official announcement, however, is yet to be made by the Union Health Ministry
‘People travelling abroad can shorten booster dose gap’
NTAGI will meet again to review the data for immunization of kids between 5 & 12 yrs.NTAGI has recommended to…
One subscription that gives you access to news from hundreds of sites
NTAGI recommends reducing gap between booster shot, second dose for those flying aboard
The panel of technical experts have recommended that those individuals who wish to travel abroad may take the booster dose…
Covid updates: India reports 2,827 cases, 24 deaths in a day
India's death toll due to Covid has climbed to 5,24,181 with 24 fatalities recorded in a day
Get all your news in one place