NO side effects due to COVID vaccine phase-1 trial, phase-2 to have 100 volunteers
Posted on: 19/Aug/2020 10:01:27 AM
At an institute near Chennai city, 30 volunteers received indigenous Covaxin (vaccine for Covid-19) trial shots in phase-1 trials and they did not get any side effects.
The latest news is the preparations are underway to begin phase-2 trials by the end of August or by early September month. Before the end of this 2020, there would be concrete results from trials and this was according to some experts.
It is common knowledge that SRM has been one of the 12 institutions chosen by ICMR to conduct trials for the vaccine developed by Hyderabad based Bharat Biotech in association with ICMR and National institute of Virology.
The volunteers have been administered with 2 doses each of 0.05ml of the vaccine for provoking immune response. This was brought out by some doctors who were involved in the trials at SRM Medical College Hospital and Research Centre.
On 23RD July 2020, phase-1 trial began and it would assess the safety of the vaccine and phase-2 would assess the immunogenicity or the vaccine`s ability to provoke an immune response. Truth is phase-2 would be done using a larger sample.
As per Dr. Melvin George, associate professor of clinical pharmacology, SRM, till now no major safety issues have been witnessed. It is known that in the phase-1 trials, 30 volunteers per testing site in the age group 18 to 55 years were used. Now for the phase-2 trials, there would be as many as100 volunteers per site (a total of 750 volunteers across 12 sites).
For the phase-2 trials, the age group of the volunteers would be 12 to 65 years. Just like phase-1 trials, when the volunteers visited the hospitals, phase-2 would also be the same and the volunteers would have to visit the hospitals on day 28, 42, 104 and 194 and their response to the vaccination would be assessed.
