Biological E seeks DCGI nod for phase-3 trial for Booster dose

Any persons who had already taken Covaxin or Covishied vaccines can take Corbevax as a booster dose

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DCGI CDSCO Regulator Drugs Controller General India
DCGI

Last Updated on January 6, 2024 by The Health Master

The Hyderabad-based Biological E vaccine manufacturing firm has recently sought the nod of Central drug regulator Drug Controller General of India (DCGI) for permitting it to conduct phase 3 clinical trials for a booster dose C-19 vaccine, which can be administered to fully vaccinated persons as a booster to further improve the immunity against the C-19 virus infections.

According to company sources, it is learnt that Biological E has developed Corbevax, a single booster dose vaccine to be administered to the fully vaccinated persons.

Any persons who had already taken Covaxin or Covishied vaccines can take Corbevax as a booster dose and enhance their immunity power against the deadly infectious disease.

After Bharat Biotech’s indigenously developed Covaxin, Biological E is the only second Indian company to have developed an indigenous Corbevax booster dose vaccine.

Currently, phase 2 clinical trials have come to an end and preparations for the conduct of phase three clinical trials are fast going on.

Biological E authorities informed that Corbevax is an RBD protein based sub-unit vaccine which can be administered in adults between the age group of 18 to 80 years.

The company authorities expressed hope that this vaccine will be released in the market in the next few months ahead once the phase-3 clinical trials are completed in the country.

A statement released by the Biological E observed that there are several literatures and research studies indicating decline in antibodies in the vaccinated individuals and that several countries have already started or are in the process of administering the booster dose vaccine to the fully vaccinated persons.

In view of this, the company had submitted an application for the grant of NOC to conduct a phase -3 clinical studies to evaluate the immunogenicity and safety of the Corbevax which administered to C-19 negative adult volunteers who had already administered with Covaxin or Covishield.

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