COVAXIN India’s Coronavirus Vaccine: Human Trials Begins
COVAXIN India’s Coronavirus Vaccine : COVAXIN , India’s first vaccine candidate for COVID-19 undergoes the first phase of human trials from today. ICMR has issued a statement recently that if everything goes right they will be able to launch the vaccine for the public by 15th August. 11 vaccine candidates have begun their human trials, out of 140, that are being developed by various firms across the globe. In India COVAXIN, developed by Hyderabad based Bharat Biotech is the first and a vaccine prepared by Zydus Cadila Healthcare limited will be the second to undergo Phase 1 of the human trial .
For a vaccine to be approved, there are many steps that have to be taken.
The general stages of the development cycle of a vaccine are:
- Exploratory stage
- Pre-clinical stage
- Clinical development
- Regulatory review and approval
- Quality control
The Clinical development stage involves Phase I , Phase II and Phase III of human trial. ICMR aims to complete the trial in a month which actually takes around a year to complete.
Out of seven Indian Vaccine candidates, Bharat Biotech is one of the two vaccines that have been given a green signal to start with their phase 1 and phase 2 human trials. Bharat Biotech developed COVAXIN, a vaccine for covid-19, in collaboration with Indian Council of Medical Research (ICMR) and NIV Pune.
How is COVAXIN developed and how is ICMR Going to Conduct trials?
COVAXIN vaccine has been developed at Bharat Biotech BSL-3 (Bio-Safety Level 3) high containment facility located in the Genome Valley in Hyderabad, using a strain which was isolated at NIV Pune, Maharashtra. The SARS-CoV-2 strain was sent to Bharat Biotech. IMCR has made 12 sites, including hospitals, and medical institutions, clinical trial centers. These sites have been given an instruction to begin with their trials by 7th July.
“This is the first indigenous vaccine being developed by India and is one of the top priority projects which is being monitored at the topmost level of the Government,” said ICMR DG Balram Bhargava, in a letter to Bharat Biotech.
Bharat Biotech has manufactured billions of doses around the world, for infections such as Zika, rotavirus, hepatitis, etc.
Another indigenous vaccine to have been granted permission to begin with their clinical trials is Ahmedabad based Zydus Cadila Healthcare limited. The Drugs Controller General of India (DCGI) has given Zydus’ ZyCoV-D the green signal to begin with their human trial phases. This is the second vaccine candidate to have gotten permission after Bharat Biotech.
India manufactures more than 60% of vaccines that are developed for UNICEF. India is a vaccine manufacturing hub.
The world is racing towards developing a vaccine for SAR-CoV-2, but it is imperative that India actively participates in the manufacturing, otherwise it won’t be sufficient for the large Indian population.
Few Recent word-wide vaccine candidates include-
• The Japanese company AnGes begins Phase I/II trials.
• The Australian company Vaxine launched a Phase I trial.
• A vaccine by CanSino Biologics was approved for military use by the Chinese government.
In terms of vaccine development Moderna vaccine has reached ahead of everyone. The Moderna Vaccine uses messenger RNA (mRNA for short) to produce viral proteins. Moderna is now looking forward to begin with their Phase III trials in July and by 2021 they hope to manufacture doses for the vaccine.
With the rising number of coronavirus cases in the country, a vaccine is the need of the hour. India has been reporting more than 25k cases every day, and now has left Russia behind and is on number 3 of the world’s worst hit countries. If COVAXIN India’s Coronavirus Vaccine passes the trail phase it will be the beginning of end of Coronavirus.