Lagatar24 Desk
New Delhi, Jan 5: The Subject Experts Committee (SEC) of the Drug Controller General of India (DCGI) on Wednesday granted ‘in principle’ approval to Bharat Biotech for conducting a ‘Phase III superiority study & Phase III booster dose study’ for its intranasal COVID vaccine for those who have taken both the doses of Covaxin or Covishield.
India had approved the administration of a third ‘precaution dose’ to fully vaccinated individuals with comorbidities on December 26.
On the basis of a doctor’s consultation, the booster shot, also known as the “precaution dosage,” will be given to frontline employees and fully vaccinated adults over 60 years of age with comorbidities. From January 10 onwards, a booster shot inoculation drive will be held.
Bharat Biotech had previously proposed clinical trials for patients vaccinated with Covishield and Covaxin, according to the news agency ANI. The pharmaceutical company intends to perform clinical studies on 5,000 people, half of whom will be vaccinated with Covishield and the other half with Covaxin.
The SEC has also requested that the pharmaceutical be required to submit protocols for approval. India will receive an intranasal vaccine by March, according to ANI’s sources. Inoculating large groups of people would be easier with an intranasal vaccination.
The third dose will be given to the specified group with the same registration ID as the previous two doses. After six months of receiving the second dose, an individual is eligible for the third dose. The user merely needed to click on the comorbidity area, and the documents would be validated at the vaccination site.
Notably, Bharat Biotech, which also developed Covaxin, had gained emergency use authorization for its vaccine, which was to be given to youngsters aged 12 to 18.