The third and the final phase of the clinical trial of ‘Covaxin’- Bharat Biotech’s vaccine for protection against the coronavirus, is all set to begin at AIIMS-Patna from Friday (December 4).
AIIMS-P to begin phase-3 vaccine trial from Dec 4PATNA: The third and the final phase of the clinical trial of ‘Covaxin’- Bharat Biotech’s vaccine for protection against the coronavirus, is all set to begin at AIIMS-Patna from Friday (December 4).
So far, 300 volunteers have enrolled for the trials. The first lot of vials from Hyderabad would reach AIIMS- P by December 3.
Covaxin is one of the first indigenous vaccines developed against Covid-19 and is derived from a strain of SARS-CoV-2 isolated by the Indian Council of Medical Research (ICMR)-Delhi and the National Institute of Virology (NIV), Pune.
AIIMS-P is in the list of 21 medical institutes selected across the country by ICMR where the third phase trial would be conducted. It is the only institute in Bihar which has been selected for the trial.
Dr CM Singh, AIIMS-P superintendent and principal investigator of the vaccine trial told this newspaper on Wednesday that the first dose of 0.5 ml intramuscular injection would be given to the registered volunteers after screening.
“As part of the trial application, a dose of 0.5 ml would be given on day zero and day 28. After receiving the dose, the volunteers would be in observation for half-an-hour and will be monitored for the next few days over the telephone,” he said.
H added, “The trial protocol requires follow-ups on day 28, 42, 104 and 194, which means over six months.”
The follow-up sampling is to check the level of immunogenicity (amount of antibody produced in a healthy body to fight against the SARS CoV-2 virus, which causes the disease).
Talking about the criteria on which the volunteers will be selected for the trial, Dr Singh said only healthy individuals above 18 years of age will be selected through a screening process and medical examination. “Around 300 people have registered for the clinical trial. However, we aim to administer 1,000 people in the final trial,” he said.