Nagpur: After getting a final nod of the drug controller General India (DCGI) for the second and third phase test of the Nasal Covaxin, Bharat Biotech Ltd will launch a national trial with Nagpur to be one of the sites.
The Government of Medical College and Hospital (GMCH) is likely to host the trial, said the source.
GMC has not received formal confirmation, but fulfills the required criteria.
The first phase of the nasal covaxine was held at the Gillurkar Multispecialty hospital in Nagpur where the volunteers were mostly from the city.
The results of this phase are quite positive to get approval for the second and third phase trial for the company.
However, now the volunteers of the vidarbha that have not been explored and less infected will be included in the trial.
The sample size of 50 in the first phase, is set to increase to 550 in the second and third phase.
To serve this purpose, GMCH, tertiary care hospitals where patients come from the periphery, preferably as sites.
A senior official who coordinated the trial of Covaxin at Nagpur told Ti that Bharat Biotech was now willing to have people from remote areas where sero’s low partnership.
“As far as regarding Nagpur, Sero’s ponytails are very high and we experience it during the child’s population trial too.
So, it is a strategic decision to have volunteers from remote areas.
GMCH may be the center, but at first, no one from the Nagpur will be given a nose vaccine , “said the official.
The doctor at GMCH also confirmed that they had completed all the necessary formalities but declined to comment.
Bharat Biotech has planned to launch a nose vaccine as a booster dose for those who have received a covaxin dose.
Dr.
Krishna Ella, Chair and Managing Director of Bharat Biotech, said the company worked on a combination of Covaxin followed by the nose vaccine.
“Those who have taken both doses of Covaxin and finishing six months may get a nose vaccine dose as additional protection.
But this will happen only after the third phase of the trial gets positive results,” said a senior doctor related to the trial at the GMCH.
Nasal Covaxin Phase II & III trials to focus on remote areas
