DUBAI: Human trials for a 100% Made-in-India COVID-19 vaccine candidate will kick off this month (July), possibly paving the way for more such trials in the subcontinent.
What does it mean?
Covaxin, developed by Bharat Biotech is India’s first “indigenous” candidate vaccine, and the first to undergo human trials in the world’s second most-populous country.
The vaccine trial was greenlighted by Indian drug regulators (Central Drugs Standard Control Organisation, CDSCO), and is based on an “inactivated” SARS-CoV-2 virus.
It’s not the only one.
In the realm of drug development, Bharat Biotech has a solid track record: It has produced over 4 billion vaccines for the world, and has successfully manufactured a vaccine for the H1N1 pandemic.
It is collaborating with Indian and foreign research institutions. This new jab was developed in tandem with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
In May, Bharat Biotech announced its joint venture with America’s Thomas Jefferson University to develop a new COVID-19 vaccine using an inactivated rabies vector platform.
Covaxin is on WHO “landscape document”, which lists more than 120 vaccine candidates from around the world. This list has 17 front-runner candidates undergoing human trials. Here’s what you need to know about Covaxin:
What is it based on?
The vaccine is actually an inoperative SARS-CoV-2 strain isolated by the NIV. The inactivated strains were then transferred to the Bharat Biotech’s BSL-3 High Containment facility located in the southern city of Hyderabad for the company’s scientists to work on them.
The virus strain was obtained in India and was instrumental in developing the vaccine quickly, the company said.
Are we going to have this Bharat vaccine by the end of July?
Probably not.
Vaccine trial phases usually last at least 28 days, though many developers ramp up trials by combining Phases I and II. Phase III is more laborious as the recruitment process of healthy volunteers representing different age groups as well as clinical evaluations take time.
Human trials in India: What happens next?
Volunteers are being recruited in India to be immunised with a new locally-made COVID-19 vaccine starting this month.
India’s Central Drugs Standard Control Organisation (CDSCO) gave the permission for human trials. It came after “pre-clinical” studies on animals suggested the vaccine is safe and effective, i.e. triggers an immune response against the virus.
This is the first India-made vaccine and developed from a strain of the virus that was isolated locally and weakened, or “killed” under laboratory conditions.
How many Indian companies are involved in COVID-19 vaccine development?
Within India, there are at least 10 vaccine development projects. Besides Covaxin, Bharat Biotech is also developing another COVID-19 vaccine, called “CoroFlu”, with US-based FluGen along with experts from the University of Wisconsin-Madison.
Not to be outdone, scientists with other Indian biotech firms are feverishly ramping up their own COVID-19 vaccine development work.
Besides Covaxin, there are seven other candidate vaccines under development in the subcontinent.
For example, Indian biotech firm Biocon Biologics Ltd. is preparing two vaccines through its R&D arm and partnerships with US firms.
Another company, the Serum Institute of India (SII), started developing its own vaccine in March even as it has signed a mass production deal with Oxford University’s Jenner Institute (vaccine research outfits).
The WHO lists Oxford's Jennery Institute as a front-runner in the global vaccine race, with its ChAdOx1-S, now undergoing Phase III (final) trials, involving several thousand volunteers.
When are we going to see at COVID-19 vaccine for everyone’s use?
It’s still all touch and go at the moment.
Most experts think a coronavirus vaccine is likely to become available by mid-2021 — about 12-18 months after the SARS-CoV-2 virus first emerged.
There are different strains of the novel coronavirus. UAE clinicians have found at least 2 strains and 70 mutations of the SARS-CoV-2.
More trials may be needed for scientists to know whether one vaccine could work against all the strains. A vaccine could very well happen soon, or before the end of the year. Once a vaccine is approved, it needs to be mass produced. That’s another challenge
India's leading vaccine makers
India is home to a number of vaccine makers, both big and small. They make doses against polio, meningitis, pneumonia, rotavirus, BCG, measles, mumps and rubella, among other diseases.
There are at least five Indian biotech firms directly involved in COVID-19 vaccine development.
1. Bharat Biotech, 2 vaccines
2. Serum Institute of India, 2 vaccines
3. Zydus Cadila, 2 vaccines
4. Biological E Ltd, 1 vaccine
5. Indian Immunologicals, 1 vaccine
6. Mynvax, 1 vaccine
7. Biocon Biologics Ltd, 1 vaccine
What’s the global COVID-19 vaccine scenario like at the moment?
There are currently 17 frontrunners on WHO’s list. The list, however, is a “landscape”, and only indicative of the on-going projects out there.
What’s a “good” COVID-19 vaccine? When will it be available?
A good vaccine is one that is both effective and safe.
Essentially, a good COVID-19 vaccine must have these both these two qualities — one cannot be without the other— induce immune response against SARS-CoV-2 in healthy populations, and no adverse side effects.
AstraZeneca has announced it is ready to provide a potential new coronavirus vaccine from September.
VACCINE TRIAL PHASES
PHASE I
Trial on different doses done, to see what’s the ideal dose for optimal immune response, usually done among young and healthy volunteers.
PHASE II
Tests immune response in various age groups (usually including very young and very old).
PHASE III
Vaccine is given to a large number of volunteers to ensure the same immune response is elicited by everyone who gets the shot.
COVID-19 in India by the numbers
[] With 18,522 new coronavirus cases registered over the past 24 hours, India's nationwide tally on Wednesday morning topped 585,000, according to the Health Ministry data.
[] Of these, the last 120,000 cases were reported in the last week.
[] Meanwhile, the death toll in the country reached 17,400 with 418 more fatalities, while a total of 348,000 patients have recovered.
[] Amid the surge, several states including eastern states of Jharkhand and West Bengal, and northeastern Assam and Manipur have re-imposed partial or full lockdown.
[] At present, eight states -- Maharashtra, Delhi, Gujarat, Tamil Nadu, Telangana, Uttar Pradesh, Andhra Pradesh, and West Bengal -- contribute 85.5 percent active caseload and 87 percent total deaths in India," the Health Ministry said in a statement.
