375 healthy volunteers; 150-day monitoring: AIIMS gets nod for Covaxin Covid vaccine trial

On July 18, All India Institute of Medical Sciences (AIIMS) Ethics Committee announced that its COVID-19 vaccine candidate Covaxin was entering the human phased clinical trials in a breakthrough development. Professor at the Centre for Community Medicine at AIIMS, Dr. Sanjay Rai, said that over 375 healthy volunteers would be enrolled starting July 20 to participate in the clinical trials of the experimental indigenous vaccine, as per a news agency report.  

"Today, we got approval from the AIIMS Ethics Committee for starting the human clinical trial of the indigenously developed Covaxin. We are launching the enrollment process from Monday,” Dr. Rai said. He added, “We are going to select healthy participants with no comorbidities and without a history of COVID-19. The age group of the study population is 18 to 55 years. This would be a randomized, double-blind, placebo-controlled clinical trial.”

Individuals would be administered with the dosage of the vaccine and would be kept under medical observations for almost 150 days. The vaccine has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), and AIIMS-Delhi is one of the 12 sites that was shortlisted by the Indian Council for Medical Research (ICMR) for the phase I and II human trials of Covaxin. In phase I trials, at least 100 volunteers would be from AIIMS to be included in the premier hospital’s search for a vaccine.  

Read: Record Number Of Samples Tested For COVID-19 On Tuesday: ICMR Officials

Read: ICMR To Conduct Pan-India Serosurvey As India's COVID Count Reach 7.9 Lakh

Speaking about the risk mitigation and concerns about the newfound vaccine, Dr. Rai said that several issues and speculations regarding the vaccine raised by AIIMS Ethics Committee some days ago were all addressed at the Ethics Committee meeting. He added, post a discussion, the panel approved to enter the vaccine in the human trials phase. "Any healthy individual who wishes to participate in the trial can send in an email on Ctaiims.covid19@gmail.com or send an SMS or call on 7428847499," Dr. Rai said, adding, that the “team will start their health screening before giving them vaccination”.  

Trials at 12 sites including AIIMS, Patna

Indian Council for Medical Research (ICMR) has commenced the trials at 12 sites including AIIMS, Patna, and few other places, according to reports. Director-General of Indian Council of Medical Research (ICMR) Dr. Balram Bhargava was quoted saying that the scientists have been making immense efforts to FastTrack the regulatory clearances for the experimental vaccine that would prove to be beneficial in combatting the coronavirus pandemic.  

Read: ICMR Clarifies Intent Of Aug 15 Deadline For COVID Vaccine; Says 'trials Yet To Begin'

Read: Latest News: From CBI Probing Tuticorin Deaths To ICMR Vaccine Update, All Headlines Here

(Image Credit: PTI)