Biological E seeks DGCI nod for phase-3 trial of Corbevax as booster dose
Pharma company Biological E has reportedly sought approval from Indian drug regulators to conduct the third-phase clinical trial of its Covid-19 vaccine that would serve as a booster dose for those who are fully vaccinated with Covishield and Covaxin.
In a statement, the Hyderabad-based company has said a lot of study has suggested that antibodies decline even among inoculated individuals and many countries have already begun or are planning to start booster doses for its citizens. Hence, it wants to evaluate the safety of the single-dose vaccine, Corbevax, in vaccinated people.
At present, the indigenously developed Corbevax, an RBD protein sub-unit vaccine, is undergoing its second and third-phase trials for being administered to adults between 18 and 80 years and the results are expected to be declared in a few days.
In September, the DCGI had also granted permission to Biological E to conduct phase 2/3 clinical trials of the vaccine in children aged between 5 and 18 years with certain conditions.
A PTI report said the Hyderabad-based firm has, meanwhile, put in an application seeking the approval of the Drugs Controller General of India (DCGI) to conduct the phase-three 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 government last week said the science relating to the use of booster doses of Covid-19 vaccines is still evolving and the developments are being closely watched.
NITI Aayog Member (Health) Dr VK 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.
"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 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 provided financial assistance to Biological-E in terms of grant-in-aid of over ₹100 crore and also partnered with it 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.
(With PTI inputs)