Explained: What stage are candidate vaccines being tested in India?

There have been several announcements from companies that have signed agreements to make Covid-19 vaccines. (AP Photo: Themba Hadebe, file)

Bharat Biotech is expected to move into phase II trials of ‘Covaxin’, its Covid-19 vaccine candidate, this week. With several announcements from companies that have entered into agreements to manufacture Covid-19 vaccines or that have announced human clinical trials for their candidates in India in recent months, The Indian Express recaps the main players to watch out for here now:

‘Covishield’ from the University of Oxford-AstraZeneca:

This vaccine, one of the most watched candidates worldwide, works with a mechanism that uses a weakened, non-replicable version of a common cold virus that infects chimpanzees to carry a code that will tell cells to build only the pointed outer layer of SARS. -CoV-2 virus (the spike protein). The body’s immune system is expected to recognize this as a threat and develop antibodies to fight the spike protein so that it is ready in case the actual virus tries to infect it.

This candidate, who is in the last stage of phase III testing on more than 10,000 human participants in countries such as the UK, Brazil and South Africa, has also entered phase II human trials in India. Here, the Serum Institute of India is expected to test the vaccine on around 1,600 participants.

Trials in India began on August 26, and two volunteers from the Bharati Vidyapeeth Medical College in Pune received the first injections.

As of August 27, at least 10 of the 17 clinical trial sites across the country that are expected to conduct these trials were still awaiting approvals from their ethics committees, without which they would not be able to begin enrolling participants. 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 1 billion doses of the vaccine for low- and middle-income countries by the end of 2021.

📣 Express explained is now in Telegram. Click here to join our channel (@ieexplained) and stay up to date with the latest

‘ZyCov-D’ by Zydus Cadila:

One of the indigenously produced pioneers in the Covid-19 vaccine race, it uses a genetically modified DNA molecule encoded with the DNA sequence of the SARS-CoV-2 virus, against which the immune response is expected to develop .

Zydus Cadila announced in early August that the candidate’s Phase I trials showed it to be “safe and well-tolerated,” which allowed it to move to the second phase of human trials on August 6. While company president Pankaj Patel previously said that Phase I and II trials would take around three months, until October, the CTRI shows that the trials, conducted with more than 1,000 participants, are expected to take about a year. to complete.

The company is reportedly looking to develop a capacity to produce 100 million doses if phase II trials are successful.

Also in Explained | Why Pune is experiencing an increase in Covid-19 cases

‘Covaxin’ from Bharat Biotech:

A controversial candidate in early July following a letter from the Indian Council for Medical Research (ICMR) pushing for a launch on August 15, this vaccine works by injecting the SARS-CoV-2 virus that has been killed in the lab. The candidate aims to use this killed virus, which is not expected to have the potential to infect or replicate in those injected with it, to induce an immune response in the body.

Currently, the candidate is expected to enter phase II human trials this week. Bharat Biotech is seeking a capacity of around 300 million doses of the vaccine, according to sources.

RBD protein vaccine by Baylor College of Medicine-Biological E:

It is a candidate recombinant protein vaccine developed using the same traditional technique used to make hepatitis B vaccines, which makes it easier to produce since most companies already have the technical knowledge to do so, according to the Baylor College of Medicine. . Biological E, which signed an agreement with BCM last month, is expected to conduct human trials for this candidate vaccine in India. These tests are likely to start this month or next, depending on when the company requests and receives permission to begin the tests.

Biological E has indicated to BCM that it has the annual capacity to manufacture up to 1 billion doses of this vaccine.

HGC019 from Gennova Biopharmaceuticals-HDT Bio:

This candidate belongs to a newer category called ‘mRNA’ vaccines, which use messenger RNA molecules that tell cells which proteins to build. The mRNA, in this case, is encoded to tell 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 instructions in the mRNA, creating copies of the spike protein, which in turn is expected to prompt immune cells to create antibodies to fight it.

Gennova, a subsidiary of Emcure Pharmaceuticals, intends to start human trials in India in October and is also planning global trials in collaboration with its partner HDT Bio in the US, Brazil and South Africa.

Currently, the company has the capacity to produce between 150 and 200 million doses per year, but is working to expand it to produce more than 1 billion doses and plans to invest a “huge” amount in this regard.

📣 The Indian Express is now on Telegram. Click here to join our channel (@indianexpress) and stay up to date with the latest headlines

For the latest news explained, download the Indian Express app.

© The Indian Express (P) Ltd