The Drug Controller General of India (DCGI) has allowed Hyderabad-based Bharat Biotech to conduct a study on mix and match of their two coronavirus vaccines — Covaxin and Adenoviral Intranasal Vaccine — in order to evaluate the immunogenicity and safety in healthy volunteers.
“A phase 2/3 randomised, multi-centric, clinical trial of heterologous prime boost combination of SARS-CoV-2 vaccines BBV 152 (Covaxin) with BBV154 (adenoviral intranasal vaccine) has been granted by the drug regulatory body,” a government official in the know of the development told CNN-News18.
The application for interchangeability study protocol of Covaxin and Adenoviral Intranasal vaccine was presented to the Subject Expert Committee by Bharat Biotech on July 29.
Covaxin is currently being administered in the country, while phase 1 clinical trials data of the adenoviral intranasal vaccine was submitted to the Central Drugs Standard Control Organisation in June.
The subject expert committee of CDSCO has recommended that Bharat Biotech should use both drops and spray for clinical trials.
A section of experts and recent studies advocated using vaccines based on two different platforms to trigger a better immune response in beneficiaries. This will be the first-of-its-kind study on mix and match of injectable and nasal Covid-19 vaccines.
Covaxin is an inactivated vaccine and is developed with the whole virion cell-derived platform. The vaccine is being manufactured by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
The adenoviral intranasal coronavirus vaccine is a single-dose jab based on the chimpanzee adenovirus vectored technology. It is being developed by the Hyderabad-based vaccine maker in collaboration with the University of Washington School of Medicine at St Louis.
The DCGI has earlier given a go-ahead to Christian Medical College (CMC) in Vellore to conduct a study on mixing Covishield and Covaxin.
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