9/9/2020 Explained: At what stage are under-trial vaccine candidates in India?
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Home / Explained / Explained: At what stage are under-trial vaccine candidates in India?
Explained: At what stage are
under-trial vaccine candidates
in India?
There have been several announcements of companies either entering into
agreements to make Covid-19 vaccines or announcing human clinical trials
for their candidates in India in the last few months.
W ritten by Prabha Raghavan | New Delhi | Updated: September 9, 2020 8:25:09 am
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9/9/2020 Explained: At what stage are under-trial vaccine candidates in India? | Explained News,The Indian Express
There have been several announcements of companies entering into agreements to make Covid-19
vaccines. (AP Photo: Themba Hadebe, File)
TOP NEWS THIS M
Bharat Biotech is expected to move to phase II trials of ‘Covaxin’, its Covid-19
Russia seeks
vaccine candidate, this week. With several announcements of companies either Sputnik phas
entering into agreements to make Covid-19 vaccines or announcing human manufacture
clinical trials for their candidates in India in the last few months, The Indian
Express recaps the major players to watch out for here now:
‘Covishield’ by University of Oxford-AstraZeneca:
One of the most closely watched candidates globally, this vaccine works on a
mechanism that uses a weakened and non-replicating version of a common cold
virus that infects chimpanzees to carry a code that will tell cells to build just the
spiky outer layer of the SARS-CoV-2 virus (the spike protein). The body’s immune
system is expected to recognise this as a threat and develop antibodies to fight the
spike protein so that it will be ready in case the real virus tries to infect it.
This candidate, in late stage phase III tests on over 10,000 human participants
across countries like the UK, Brazil and South Africa, has also entered phase II
human trials in India. Here, Serum Institute of India is expected to test the
vaccine on around 1,600 participants.
The India trials started on August 26, with two volunteers in Pune’s Bharati
Vidyapeeth Medical College receiving the first shots.
As of August 27, at least 10 of the 17 clinical trial sites across the country expected
to conduct these trials were still awaiting approvals from their ethics committees,
without which they would not be able to begin enrolling participants. The phase
II/III trials in India are expected to take seven months–potentially until March
2021–according to CTRI.
Serum has been tasked with manufacturing a billion doses of the vaccine for low-
and middle-income countries by the end of 2021.
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TOP NEWS THIS M
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Sputnik phas
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‘ZyCov-D’ by Zydus Cadila:
One of the indigenously produced frontrunners in the Covid-19 vaccine race, this
uses a genetically engineered DNA molecule coded with the DNA sequence of the
SARS-CoV-2 virus, against which the immune response is expected to be
developed.
Zydus Cadila announced early in August that phase I trials of the candidate
showed it was “safe and well tolerated”, allowing it to move to the second phase
of human trials on August 6. While company chairman Pankaj Patel earlier said
that the phase I and II trials would take around three months–until October–
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9/9/2020 Explained: At what stage are under-trial vaccine candidates in India? | Explained News,The Indian Express
CTRI shows that the trials, conducted on over 1,000 participants, are expected to
take around a year to complete.
TOP NEWS THIS M
The firm is reportedly looking at building a capacity to produce 100 million doses Russia seeks
if phase II trials are successful. Sputnik phas
manufacture
Also in Explained | Why Pune is seeing a surge in Covid-19 cases
‘Covaxin’ by Bharat Biotech:
A candidate that raked up controversy in early July following an Indian Council
of Medical Research (ICMR) letter pushing for an August 15 launch, this vaccine
works by injecting SARS-CoV-2 virus that has been killed in the lab. The
candidate aims to use this dead virus, which is not expected to have the potential
to infect or replicate in those injected with it, to induce an immune response by
the body.
The candidate is currently expected to enter phase II human trials this week.
Bharat Biotech is looking at a capacity of around 300 million doses of the vaccine,
according to sources.
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RBD protein vaccine by Baylor College of Medicine-Biological E:
This is a recombinant protein vaccine candidate developed using the same
traditional technique used to make vaccines against Hepatitis B, making it easier
to produce as most companies already possess the technical know-how for it,
according to the Baylor College of Medicine. Biological E, which entered into an
agreement with BCM last month, is expected to conduct human trials for this
vaccine candidate in India. These trials are likely to begin this month or next,
depending on when the company applies for and receives permission to begin the
testing.
Biological E has indicated to BCM that it has the annual capacity to make up to a
billion doses of this vaccine.
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9/9/2020 Explained: At what stage are under-trial vaccine candidates in India? | Explained News,The Indian Express
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HGC019 by Gennova Biopharmaceuticals-HDT Bio:
This candidate belongs to a newer category called ‘mRNA’ vaccines, which make
use of the messenger RNA molecules that tell cells what proteins to build. The
mRNA, in this case, is coded to tell the cells to recreate the Covid-19 spike protein–
the spikes found on the surface of the SARS-Cov-2 virus. Once injected into the
body, the cells will use the mRNA’s instructions, creating copies of the spike
protein, which is in return expected to prompt the immune cells to create
antibodies to fight it.
Gennova, a subsidiary of Emcure Pharmaceuticals, intends to initiate human
trials in India by October and is also planning global testing in collaboration with
partner HDT Bio in the US, Brazil and South Africa.
At present, the firm has the capacity to make around 150-200 million doses
annually, but is working towards scaling up to make over a billion doses and is
planning to invest a “huge” amount towards this.
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