SEC to review Bharat Bio’s intranasal jab for use as booster soon

The Subject Expert Committee (SEC) under India’s drug regulator will soon review Bharat Biotech‘s application for approval of its intranasal vaccine as a booster dose, people in the know told ET.

The company has done clinical trials for the vaccine used as a heterologous booster dose after Covishield and Covaxin – and has submitted the data to the Drugs Controller General of India (DCGI) for the review.

Hyderabad based Bharat Biotech has sought market authorisation approval from Drugs Controller General of India (DCGI) for their intranasal heterologous booster in the 5-18 age group.

“The SEC will soon take up their application for review and evaluate their data as a booster dose,” said a person in know of the matter.

Clinical trials were conducted to evaluate Incovacc (intranasal vaccine) as a primary dose schedule and as a heterologous booster dose for subjects who have previously received 2 doses of the two commonly administered covid vaccines in India.

Earlier this month the drug regulator approved the country’s first intranasal vaccine-Incovacc by Bharat Biotech for primary immunisation of those above 18 years.

“We are proud to announce the approval of Incovacc, a global game changer in Intra Nasal vaccines technology and delivery systems. Despite the lack of demand for Covid-19 vaccines, we continued product development in intra-nasal vaccines to ensure that we are well prepared with platform technologies for future infectious diseases. We thank the ministry of health, the CDSCO, the department of biotechnology, government of India, and Washington University St. Louis for their support and guidance. Incovacc has been designed for efficient distribution and easy administration,” Dr Krishna Ella, chairman & managing director, Bharat Biotech had earlier said.

(With inputs from health)