Updated: September 13, 2020 11:30:55 am
Coronavirus (COVID-19) Vaccine Tracker: Bharat Biotech is expected to move to phase II trials of ‘Covaxin’, its Covid-19 vaccine candidate, this week. With 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, 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.
‘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–CTRI shows that the trials, conducted on over 1,000 participants, are expected to take around a year to complete.
The firm is reportedly looking at building a capacity to produce 100 million doses if phase II trials are successful.
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‘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.
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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