Biological E has filed an application with the Drugs Controller General of India (DCGI) seeking approval to conduct the Phase 3 study of its Covid-19 vaccine Corbevax.

The Phase 3 study will assess Corbevax, the second indigenously developed Covid-19 vaccine, as a booster dose for use in people vaccinated with Covishield or Covaxin.

Corbevax is an RBD protein sub-unit vaccine, currently under Phase 2/3 clinical trials in adults aged 18 years to 80 years, and the results are expected this month.

Last month, Biological E has received the DCGI approval to initiate the Phase 2/3 study of its Covid-19 vaccine in children and adolescents aged 5 to 18 years.

Corbevax was developed by Biological E, in partnership with Baylor College of Medicine in Houston, US, and biopharmaceutical firm Dynavax Technologies.

In its application submitted to DGCI, Biological E stated: “Currently there are several literatures indicating the decline in antibodies in the vaccinated individuals, and that several countries have begun or are in the process of administering booster dose to the people who have completed the primary vaccination.

“In view of this, we are herewith submitting the application for grant of NOC to conduct a Phase 3 clinical study to evaluate the immunogenicity and safety of Corbevax when administered to Covid-19-negative adult volunteers primed with either Covishield or Covaxin.”

The Central Drugs Standard Control Organisation (CDSCO)’s Subject Expert Committee (SEC) on Covid-19 is expected to review the matter in its next meeting, The Press Trust of India reported.

In June this year, India’s Union Health Ministry announced that Biological E will supply 300 million doses of Corbevax to the central government by December this year.

The firm has been developing the Covid-19 vaccine with support from the Department of Biotechnology and its PSU Biotechnology Industry Research Assistance Council (BIRAC).

NITI Aayog member Dr V K Paul, at a press conference, said: “This is an evolving science and a paradigm of information, that data is still emerging. We are watching this science very very carefully through our NTAGI system.

“We know that Covaxin has done a study on booster doses and those results can be available anytime.

“We also know that WHO has not given a clear-cut recommendation on the matter, we are watching science as it emanates and in India also, there are studies which are looking at this aspect.”