Phase 1 vaccine trial will be conducted on healthy people aged 18-55 years who have no co-morbidity, said AIIMS director
The institute is among the 12 sites where human trials for Covaxin will be conducted
Days after announcing that All India Institute of Medical Sciences (AIIMS) will conduct the human clinical trial of India's first "indigenously" developed Covid-19 vaccine candidate Covaxin, AIIMS Director Dr Randeep Guleria said the trial will be conducted in three phases. A total of 1,125 samples have been collected, which will be used for trials in the first two phases, he added.
"Phase 1 vaccine trial will be conducted on healthy people aged 18-55 years who have no co-morbidity. A total of 1125 samples have been collected of which 375 people will be studied in the first phase and 750 people between 12-65 years will be studied in the second phase," said Guleria.
"To test the efficacy and effectiveness of the vaccine a trial will be conducted under phase-3. The trail will be conducted in AIIMS," he added.
"Launching of vaccine depends on its overall trial, we will have check the effectiveness of the vaccine for at least 6 months. By end of this year or early next year, there are chances that we will have a vaccine," said Dr Sanjay Rai, Head of Community Medicine Dept, AIIMS, New Delhi.
The institute is among the 12 sites where human trials for Covaxin will be conducted.
Any healthy individual who wishes to participate in the trial can send in an email on Ctaiims.firstname.lastname@example.org or send an SMS or call on 7428847499. The first and second phase in AIIMS (Delhi) will choose only 100 participants out of 375 volunteers and the remaining will participate at other sites.
AIIMS Ethics Committee on Saturday gave its approval for conducting the human clinical trial of the indigenously developed Covid-19 vaccine candidate Covaxin.
Earlier, human dosing of the vaccine developed by Bharat Biotech India (BBIL) in collaboration with ICMR’s National Institute of Virology (NIV) also started on Wednesday, with the vaccine being given to participants at All India Institute of Medical Sciences, Patna and Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) at Rohtak in Haryana, a spokesperson said in a statement on Friday, according to a Mint report.
The country's drug regulator had recently given a green signal for human clinical trials for Covid-19 vaccine candidate Covaxin, which has been developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV).
Apart from this, Pharma major Zydus Cadila had also last week started clinical trials of its Covid-19 vaccine candidate with the first human dosing.
Vaccine major Serum Institute of India, which is working on the AstraZeneca Oxford vaccine, plans to start human trials in India in August 2020.
Moreover, the AIIMS director Guleria today said there was not much evidence of community transmission of novel coronavirus at national level. However, there are certain hotspots across the country where local virus spread is happening, he added.
He added that certain areas have hit their peak in terms of cases recorded. Delhi seems to have done so because the cases have declined significantly. However, according to the director, certain other areas are yet to reach the peak as cases seem to be increasing there.
The national capital had witnessed a surge in the cases of novel coronavirus cases over the past one month. However, the number of active cases has seen a dip over the past few weeks.
Speaking at a press conference in New Delhi, Guleria also added that India's coronavirus-related mortality rate is much lower than that of the world's average rate. He said, "If you look at the data from Southeast Asia, not just India, the mortality rate is much lower than what happened in Italy and Spain or what is happening in the United States."
On Sunday, India’s Case Fatality Rate fell below 2.5% for the first time since the pandemic outbreak, the government said.
"The Case Fatality Rate is progressively falling and currently, it is 2.49%. India has one of the lowest fatality rates in the world," the Ministry of Health and Family Welfare said.
The ministry further said that many states have conducted the population surveys to map and identify the vulnerable population like the elderly, pregnant women and those with co-morbidities.
Meanwhile, India today saw a record single-day spike of 40,425 fresh coronavirus cases, pushing its tally to 11,18,043 while the death toll due to the infection rose to 27497, according to the health ministry data. 681 fatalities were reported in 24 hours.
However, 7,00,086 people having recovered covid so far in India while the number of active cases stand at 3,90,459. In 24 hours, 22,664 patients recovered. The number of recovered Covid-19 patients now exceeds active cases in India by 3,09,627.
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