19 Aug 2020: India: Serum Institute's COVID-19 vaccine goes into Phase-2/3 trials
The clinical study will confirm the efficacy and safety of the shot, which could eventually help Indians protect themselves from the ongoing pandemic.
Here is more about the trial and the vaccine.
Trial: Study with 1,600 people across 17 sites
The potential vaccine, named Covishield, will be given to as many as 1,600 volunteers across 17 Indian sites, including AIIMS New Delhi and ICMR's research center in Gorakhpur.
According to news agency ANI, the volunteers will be split into two groups - one with 400 participants and the other with 1,200 - and randomized to be injected with Covishield or a placebo for comparison.
Fact: Participants have to be 18 or older
To be enrolled in the study, which involves vaccination with two doses at a gap of 28 days, the participants have to be 18 years old or more and healthy - with no history of COVID-19 or any other serious condition.
Goal: Goal to establish safety, immunogenicity
With the smaller cohort, SII plans to check the immunogenicity - ability to provoke an immune response - of the vaccine.
Meanwhile, the larger one will be used to determine how safe it is on the Indian population and whether there are any serious side effects.
Notably, neither the participants nor the workers administrating the shot will know what they are giving or receiving.
Data: Initial data has already shown efficacy
While the tests in India have just begun, the vaccine in question, internationally dubbed ChAdOx1 nCoV-19, has already shown promise in early Phase-1/2 trials.
In that study, published by medical journal Lancet, the shot generated a dual immune response, comprising antibodies and T Cells, in all the study participants.
The subjects did not witness any major adverse side effects.
Availability: Availability possible by the end of the year
Last week, Adar Poonwalla had said that if these trials are successful, the vaccine would be available for inoculation in India by December.
He claimed that the institute will begin at-risk vaccine manufacturing by the end of August to make sure sufficient supply remains available by the time of approval and distribution.
The manufacturing effort has been backed by funding from the Gates Foundation.