Bharat Biotech's intranasal booster vaccine can be a game-changer if it provides mucosal immunity against COVID-19, said Dr Sanjay Rai, Professor for Community Medicine at AIIMS as the clinical trials for the vaccine commenced on Friday.
The clinical trials for phase three of the BBV154 vaccine developed by the Hyderabad-based firm started at the All India Institute of Medical Sciences (AIIMS) Delhi today.
"We don't know the result. Currently, we are in a phase three trial and if this vaccine is going to provide a mucosal immunity, then definitely that will be again a game-changer," Dr Rai told ANI.
The registration for the phase three clinical trials of the vaccine can be done either via email or on WhatsApp. People above the age of 18 years with a vaccination history of more than five months but less than seven months are eligible to participate in the trial, Dr Rai said.
Elaborating on the eligibility, he further elaborated that those registering for the trials should have taken the second dose of the COVID-19 vaccine between August 10 and October 10, last year.
"I believe the recruitment will be over in one week's time," Dr Rai said.
This trial will be heterologous on both, those who have taken two doses of Covaxin or Covishield.
The Drugs Controller General of India (DCGI) had granted permission to the Hyderabad-based pharmaceutical company to conduct clinical trials of intranasal booster vaccine dose in the country in January 2021.
The NOC letter by DCGI reads: "Central Licensing Authority hereby permits Bharat Biotech International limited to conduct clinical trials of the new drug or investigational new drug."
The dosage form of the vaccine is liquid for the intranasal route of administration and every single dose contains 0.5ml. The trials of the intranasal vaccine will take place at nine different places in the country.
( With inputs from ANI )
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