Biological E seeks DCGI emergency use nod for Corbevax as booster in adults vaccinated with Covaxin, Covishield
According to the EUA application submitted to DCGI, Biological E in a phase-3 placebo-controlled clinical study, based on the drug regulator's nod, has evaluated the safety and immunogenicity of Corbevax as a single-dose booster in Covid-negative adults fully vaccinated with either Covishield or Covaxin.;
Advertisement
New Delhi: Biological E has submitted an application to India's 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 Wednesday.
The Drugs Controller General Of India (DCGI) had already approved Corbevax, India's first indigenously developed RBD protein subunit vaccine, for restricted use in emergency situations for those aged five and above.
Currently, it is being used to inoculate children in the age group of 12 to 14 years.
According to the EUA application submitted to DCGI, Biological E in a phase-3 placebo-controlled clinical study, based on the drug regulator's nod, has evaluated the safety and immunogenicity of Corbevax as a single-dose booster in Covid-negative adults fully vaccinated with either Covishield or Covaxin.
The 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 Corbevax.
As of now, the precaution dose is of the same COVID-19 vaccine used for administering the first and second doses.
India began administering precaution doses of Covid vaccines to healthcare and frontline workers and those aged 60 and above with comorbidities from January 10.
The comorbidity clause was removed in March, making all people aged above 60 years eligible for the precaution dose of Covid vaccine.
India on April 10 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.
Read also: Govt to expedite process of recognition of Biological E Corbevax by other countries
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.