The Subject Expert Committee (SEC) of India’s drug regulatory authority is scheduled to meet on Tuesday, January 4, to examine the use of Bharat Biotech's intranasal COVID vaccine as a booster or a third dose. It has been learnt that Bharat Biotech had proposed to use this vaccine as a booster dose in people who have already been vaccinated with Covaxin or the Serum Institute of India (SII)-manufactured Covishield. As per sources, the SEC of the Drug Controller General of India (DCGI) is scheduled to meet at noon on January 4.
The Hyderabad-based biotechnology company, in its application, has proposed to use its intranasal vaccine - BBV154 - as a heterologous booster dose in people who have already been inoculated with two doses of either Bharat Biotech’s Covaxin or SII’s Covishield.
As per the trial schedule, Bharat Biotech will conduct clinical trials on 5,000 healthy subjects of which 2,500 have received Covishield and another 2,500 have been inoculated with Covaxin. The intranasal booster dose will be administered after a time period of six months from the second COVID-19 vaccine.
In December 2021, the company had sought permission to conduct a phase 3 clinical trial of its intranasal COVID-19 vaccine as a booster dose from the DCGI. The intranasal vaccine which is expected to be suitable for both children and adults is a needle-free, non-invasive, and easy to administer vaccine. Bharat Biotech’s ‘game changer’ nasal vaccine, however, is yet to be approved by India.
On December 25, addressing the nation, Prime Minister Narendra Modi had assured that soon the country will develop a nasal vaccine and the world’s first DNA vaccine. Three big announcements made by PM Modi on December 25, include: Children between the ages of 15 to 18 will be vaccinated from 3 January 2022; Healthcare and frontline workers will be provided with "precautionary doses" from 10 January 2022; and people above 60 years of age who have co-morbidities can avail a 'precaution dose' of the COVID vaccine on doctor's advice from 10 Jan 2022.
It should be mentioned that amid the soaring COVID-19 cases, in a hopeful development, India has successfully vaccinated more than 40 lakh teenagers who are in the age group of 15-18 years, against COVID, on the first day of the vaccination for youngsters on January 3 till 8:30 pm.
India on Monday, January 3, reported 33,750 fresh coronavirus infections with 10,846 recoveries in the last 24 hours. According to data provided by the Union Health Ministry, out of the total infections, active cases account for less than 1%, which is currently at 0.42%, the lowest since March 2020. The COVID recovery rate stands at 98.20%. To date, the country has administered 1,46,71,75,846 COVID vaccine doses under the nationwide vaccination drive.