Bharat Biotech backed COVAXIN starts clinical trials, 375 people enrolled
India is witnessing a staggering rise in the number of infections day by day and is now the third-worst affected country hit by the pandemic, after USA and Brazil.
Experimental medicines and therapies have helped the officials achieve a good recovery rate so far. Globally, top medical minds are involved in the development of a novel coronavirus vaccine which could help achieve mass inoculation and contain the spread to an extent. In India too, development is happening in an advanced way. Of nearly seven candidates in play, 2 homegrown vaccines have now proceeded to start clinical trials of their prototypes.
COVAXIN proceeds to trials
Hyderabad based Bharat Biotech International Limited (BBIL), which is involved in the development of the vaccine announced the initiation of phase I of its clinical trials, for which, 385 people have been recruited so far. According to reports, the trials began on July 15 where 12 hospitals across the nation were chosen to participate.
The vaccine, which uses an inactive version of the virus is being co-developed in partnership with Indian Council of Medical Research (ICMR) and National Institue of Virology (NIV), Pune.
AIIMS Patna selects 18 healthy volunteers for the trial
The news comes after AIIMS Patna announced its participation for the same. The medical institute in Patna will be conducting the clinical trials on 18 volunteers who are between the age of 18 to 55. The medical reports are being closely analyzed before the vaccine doses are administered.
How will the trials happen?
BBIL, which is known to be one of the leading vaccine makers in India and has previously collaborated with global firms for vaccine production said that the first phase of the trial will be randomized double-blind clinical trials, wherein some of the volunteers will be administrated a vaccine dose while others will be given a placebo, to see how the vaccine works. While phase I usually involves 30-40 participants, COVAXIN's trials are being advanced and involve a larger pool of candidates.
Zydus Cadila has initiated human trials as well
While COVAXIN was the first vaccine to be regulated by the Drug Controller Board of India (DGCI) in early July, Ahmedabad based Zydus Cadila's novel COVID-19 vaccine, ZyCOV-D became the first one to proceed with the human trials. The news was announced on July 16 by the country's health minister, Dr HarshVardhan.
The development of ZyCOV-D was accelerated after pre-clinical studies and animal testing showed beneficial results. Zydus Cadila chairman, Pankaj Patel also concurred saying that they are hopeful of having the vaccine available for the masses by early 2021 and finish phase III in the next 3 months.
"We are expecting the phase-1 and phase-2 studies to be completed in 3 months...Thereafter if the data is convincing. The vaccine will be approved for use"
He also added that the company is ramping up production to meet with any sort of emergency if needs arise.
Vaccine an important tool for us, says ICMR
Not only is ICMR making sure that India's vaccine development meets safety and standards, but the medical board also firmly believes that a vaccine is crucial to control the pandemic spread in the country. At a recent briefing, ICMR head, Balram Bhargava said testing and development is on the right track.
“India is well-known as the pharmacy of the world... any vaccine candidate that’s produced or developed in any part of the world will ultimately have to be scaled-up in India or by China."
"Efforts are being taken to ensure that not a single day is wasted for regulatory or approval purpose, without compromising on the science, quality, and ethics part of it...Approximately 1,000 human volunteers are participating in clinical trials for each of the two vaccine candidates and pre-clinical experiments for these as well as other vaccines are also being done at the National Institute of Virology, Pune."
What other vaccines are being worked on globally?
World over, out of 110+ candidates, at least 5 vaccine makers are involved in phase I and phase II studies of their prototypes. Oxford University and Moderna, two of the most talked-about candidates right now are in phase III of their testing and it is expected that a model will be ready before 2020 ends. A lot of crucial phase testing and development is going on right now and countries have signed pacts with the two for the same.
When can we expect an Indian vaccine?
While trials on COVAXIN and ZyCoV-D continue to be fast-tracked, officials still remain tight-lipped about their availability for the masses. Meanwhile, Serum Institute of India (SII), which is overseeing the production of many vaccines told a media house that they are ready to produce up to 100 million doses in the next three months if approvals are met with.