Biological E Seeks Regulator's Nod For Phase-3 Trial Of Booster Dose

Hyderabad-based pharmaceutical company Biological E has sought permission from India's drug regulator to conduct the phase-3 clinical trial for its COVID-19 vaccine Corbevax as a single booster dose for those who have been fully vaccinated with Covishield or Covaxin.

Currently, phase 2/3 clinical trials of the second indigenously developed Corbevax, an RBD protein sub-unit vaccine to be administered in adults aged 18 years to 80 years, is underway and the results are likely to be declared this month.

The company, meanwhile, has put in an application seeking the nod of the Drugs Controller General of India (DCGI) to conduct the phase-3 clinical study of Corbevax as a single booster dose in those fully inoculated with either Covishield or Covaxin.

"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," it said.

"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," stated the application submitted to DGCI last week.

The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) is likely to take up the matter in its next meeting.

The DCGI in September also granted permission to the Biological E to conduct phase 2/3 clinical trials of the vaccine in children aged between 5 and 18 years with certain conditions.

The government last week said that the science relating to the use of booster doses of COVID-19 vaccines is still evolving and the developments are being closely watched.

At a press conference, NITI Aayog Member (Health) Dr V K Paul had said there are several studies that are looking into the subject of booster doses.

"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," he had said.

"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," he had said.

Biological E will supply 30 crore doses of Corbevax to the central government by December, as announced by the Union Health Ministry in June. The Union Health Ministry finalised arrangements with the Hyderabad-based vaccine manufacturer to reserve 30 crore COVID-19 vaccine doses, an official statement had said.

The Biological-E's COVID-19 vaccine candidate has been developed with support from the Department of Biotechnology and its PSU Biotechnology Industry Research Assistance Council (BIRAC) from the preclinical stage to phase-3 studies.

The Department of Biotechnology has not only provided financial assistance in terms of grant-in-aid of over Rs 100 crore but has also partnered with Biological-E to conduct all animal challenge and assay studies through its Research Institute Translational Health Science Technology Institute (THSTI), Faridabad, a health ministry statement earlier had stated.

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