JOIN USDCGI nod to Bharat Biotech for study on mixing Covaxin and its nasal vaccine: Report
The Drug Controller General of India (DCGI) has given its nod to Bharat Biotech to conduct a study on mixing Covaxin and its own intranasal vaccine to evaluate the immunogenicity and efficacy, according to a report by CNN-News18.
“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 aware of the development told the news agency.
The subject expert committee of Central Drugs Standard Control Organisation (CDSCO) recommended that Bharat Biotech use both drops and spray for clinical trials, the publication reported.
DH could not independently verify the report.
The study, if conducted, will be the first of its kind involving the mixing of an injectible and a nasal vaccine.
An expert panel of CDSCO had July 29 recommended giving approval to Bharat Biotech for carrying out a study on interchangeability of its Covaxin and the under-trial adenoviral intranasal vaccine candidate BBV154, but asked the Hyderabad-based firm to remove the word "interchangeability" from the study title and submit a revised protocol for approval.
The CDSCO had granted permission to conduct of phase-I clinical trial of intranasal adenoviral vector Covid-19 vaccine (BBV154) -- in the age group of 18 years and above – to Bharat Biotech on February 12.
Most vaccines are administered by injection through intramuscular or subcutaneous route. But, intranasal vaccines are administered as a nasal spray and offer a needle-free approach for vaccine administration
On Wednesday, the DCGI gave its approval for a study on the mixing of Covishield and Covaxin.