NEW DELHI: Indian Council of Medical Research on Tuesday announced that two home-grown COVID-19 vaccine candidates have completed phase 1 clinical trial now but researchers associated with one potential vaccine told this newspaper that the study is still underway.
It could be nearly a month before the vaccine trial could enter phase 2, they told The New Indian Express.
"At present, we have 3 vaccines in India which are in different phases of clinical testing," said ICMR director general Dr Balram Bhargava in a press conference on Tuesday.
"The 2 vaccines- Bharat Biotech vaccine & DNA vaccine of Zydus Cadila have completed phase 1 and have embarked on phase 2 while the third is Oxford (University) vaccine."
Dr Bhargava, last month, had drawn massive criticism for shooting a stern letter to the Principal Investigators (PIs) at the institutions selected for Covaxin trial, asking them to fast-track the process so that it can be launched for public use by August 15.
Covaxin is a potential vaccine against Covid 19 by Bharat Biotech, developed with support from the National Institute of Virology.
PIs involved in its trial, contrary to what Dr Bhargava said in the press conference, said that it will take at least a month for the first phase of the trial to be completed.
"The vaccine has to be given in two doses at a gap of 2 weeks and after 28 days the blood samples of the volunteers is to be evaluated mainly to assess for safety and to also see if its generating immunogenic response," said Dr Prabhakar Reddy, the PI for the trial at the Nizam’s institute of Medical Sciences, Hyderabad.
NIMS, Hyderabad is one of the 12 trial sites where Covaxin is being tried in 750 volunteers in phase 1.
"However, we have given just the first dose yet and it will take some time to complete the interim analysis," he said.
The same was also confirmed by PIs at various centres including SRM Hospital and Research Center, Kancheepuram, Institute of Medical Sciences and SUM Hospital, Jajapur and AIIMS, Delhi.
Dr Sanjay Rai, PI for the trial at AIIMS, Delhi--where the phase 1 trial began only on July 23, said that it will take about a month for the phase 1 study to be completed.
"We can move to phase 2 once the blood samples from the volunteers—2 weeks after they have received the second dose—are thoroughly evaluated for crucial health parameters," he said.
For the vaccine candidate by Zydus Cadila, the phase 1 trial however was to be carried out at only one site in Ahmedabad and it has been completed now, said sources.
"A report from the data safety monitoring board is expected on phase 1 trial on Wednesday after which phase 2 trial will start at 8 centres—the screening for phase 2 meanwhile has begun," said one of the PIs involved in the trial.
Meanwhile phase 2 and 3 trials for vaccine candidates by Oxford University, for which Serum Institute of India, is a manufacturing partner will be conducted across 17 sites in the country, said Dr Bhargava in the press briefing.