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Preparations on for second phase of human clinical trial of 'Covaxin' vaccine

"The Phase I of the trial is still continuing as we are planning for the start of the Phase II trial shortly," Dr E Venkata Rao, Principal Investigator of the trial at Institute of Medical Sciences and SUM Hospital, faculty of medical sciences, said.

August 31, 2020 / 11:02 AM IST
2 | Next crop of COVID-19 vaccine developers take more traditional route: The handful of drugmakers dominating the global coronavirus vaccine race are pushing the boundaries of vaccine technology. The next crop under development feature more conventional, proven designs. The world will need several different vaccines to fight the COVID-19 pandemic, given the sheer size of global need, variations in effects on different populations, and possible limits of effectiveness in the first crop. Many leading candidates now in final-stage testing are based on new, largely unproven technology platforms designed to produce vaccines at speed.

2 | Next crop of COVID-19 vaccine developers take more traditional route: The handful of drugmakers dominating the global coronavirus vaccine race are pushing the boundaries of vaccine technology. The next crop under development feature more conventional, proven designs. The world will need several different vaccines to fight the COVID-19 pandemic, given the sheer size of global need, variations in effects on different populations, and possible limits of effectiveness in the first crop. Many leading candidates now in final-stage testing are based on new, largely unproven technology platforms designed to produce vaccines at speed.

Preparations are underway at a hospital here for the commencement of the second phase of human clinical trial of 'Covaxin', India's indigenous COVID-19 vaccine, officials said.

"The Phase I of the trial is still continuing as we are planning for the start of the Phase II trial shortly," Dr E Venkata Rao, Principal Investigator of the trial at Institute of Medical Sciences and SUM Hospital, faculty of medical sciences, said.

The blood samples collected from the volunteers who received the vaccine were to ascertain how effective the vaccine was in terms of the level of antibodies developed, Dr Rao said, adding that there had been 'no side effects' in the first phase trial of the vaccine.

The IMS and SUM Hospital is one of the 12 medical centres in the country chosen by the Indian Council for Medical Research (ICMR) for conducting the human trial of the vaccine developed by Hyderabad-based Bharat Biotech.

"Two doses of the vaccine were administered to each volunteer after they were selected through a screening process conducted over a period of three to seven days prior to vaccination. The first dose was administered on Day Zero while the blood sample was collected. The second dose was given on Day 14 and the blood sample was also collected," Dr Rao said.

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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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Blood samples of the volunteers will also be collected on different days (28, 42, 104, 194 day) for estimating the duration of protection subsequently, he added. Dr Rao said there was a lot of enthusiasm among people to be part of the second phase of the human trial.

Those who wish to be part of this trial could contact the centre at http://ptctu.soa.ac.in, he said.
PTI
first published: Aug 31, 2020 10:50 am

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