The first Indian vaccine candidate for COVID-19 was granted permission for the human trials just four days ago. The Indian Council of Medical Research said on Friday that they wanted to "launch the vaccine for public health use latest by August 15".
On 2nd July, the Director-General of the council Balram Bhargava wrote to 12 institutions participating in the trial to "fast track all approvals". He also added that the participants who would be tested should be enrolled "no later than 7th July".The letter also mentioned that this vaccine is currently "the top priority of the government".
What is Covaxin?
It is an “inactivated” vaccine — one made by using particles of the Covid-19 virus that were killed, making them unable to infect or replicate. Injecting particular doses of these particles serves to build immunity by helping the body create antibodies against the dead virus, according to BBIL.
In general, a vaccine is developed and tested over a number of stages.
- Stage I: R&D,
- Stage II: Pre-clinical,
- Stage III: Clinical trials,
- PHASE I
- PHASE II
- PHASE III
- Stage IV: Regulatory review,
- Stage V: Manufacturing,
- Stage VI: Quality control
For Covid-19, this has been fast-tracked.
- Stage I: R&D,
- Stage II: Pre-clinical,
- Stage III: Clinical trials,
- PHASE I
- PHASE II
- PHASE III
- Stage IV: Manufacturing
Approved vaccine for human trials based on Phases:-
Phase 1: This phase of the clinical trial is small and is used to determine the safety profile.
Phase 2: The sample size for phase two is bigger and it looks at the immune responses triggered by the vaccine.
Phase 3: A vaccine is commercially available only after the phase 3 trial. It has a much bigger sample size with thousands of participants.
The trial document for the Covaxin does not mention anything about the phase 3 and there appears to be some confusion in the sequence of phase 1 and phase 2 trial.
More than a dozen Covid-19 vaccines from over 100 candidates globally are currently being tested in humans, and some have shown potential in early-stage trials. However, no vaccine has yet been approved for commercial use.
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