New Delhi: The human trial for the indigenously developed Covid-19 vaccine Covaxin has begun at AIIMS Delhi, institute director Randeep Guleria announced Monday.
The All India Institute Of Medical Sciences (AIIMS) was given the go-ahead by its Ethics Committee and has begun the recruitment process for the trial, Guleria said, which will include a total of 100 healthy volunteers between the ages of 18 and 55.
“All trial sites combined will have a total sample size of 1,125 healthy volunteers. Out of this, 375 will be studied in phase one. In AIIMS Delhi, 100 healthy volunteers will be recruited,” said Guleria, who added that they were looking to conclude the recruitment process as “quickly as possible”.
The 100 subjects will be divided into a placebo arm and vaccine arm. Various departments will closely monitor the trial group for side effects.
Phase one will also include three variations of the vaccine with two different doses to test the efficacy of each dosage.
Once the safety of the vaccine is established in phase one, phase two of the trial will commence, which will recruit 750 people between the ages of 12 and 65.
“If we find [the vaccine] is safe, immunogenetic (has the ability to provide enough antibodies) and has no issues of side effects, we should be able to have a result in the next two to three months. But we must follow up with subjects for 28 days and then again at a later stage,” Guleria said.
Covaxin was developed by Bharat Biotech, and is backed by the Indian Council of Medical Research (ICMR) and the National Institute of Virology.
The vaccine became the subject of controversy when a letter from the ICMR to all 12 trial sites asked principal investigators to expedite their trials such that the vaccine could be ready for a public roll out by 15 August. Clinical trials take a minimum of a few years to establish safety of the vaccine before trials can be expanded to a wider group of people.
Following the blowback, the ICMR said the letter was intended to remove “red tape” but in no way called for cutting short the scientific process or rigour for readying a vaccine.
‘No community transmission at national level’
On a question on how prevalent Covid-19 is in the country, Guleria said there was “no evidence” for community transmission at a national level yet.
“If you look at the country’s data and the ICMR’s sero-surveillance data, there is not much evidence to show that at a national level community transmission is happening,” he said.
India reported a total of 11,18,043 Covid-19 cases Monday, of which 3,90,459 were active. Number of recoveries far outpaced active cases at 7,00,086 while 27,497 people had so far succumbed to the disease.