Vaccine maker Bharat Biotech plans to start the phase-3 clinical trial of its COVID-19 vaccine Covaxin in October to test safety and efficacy.
The company plans to test the vaccine on about 25,000 - 30,000 people in phase -3.
Currently, Covaxin, which is based on the inactivated whole virion of SARS-CoV2 is in the phase-2 trial. Bharat Biotech has completed the phase-1 and submitted the data to Drug Controller General of India (DCGI).
Meanwhile, Bharat Biotech said it is producing vaccines at risk at two of its Biosafety Safety Level (BSL)-3 facilities in Hyderabad.
"The current capacity is 100-200 million doses at these two facilities," said Sai Prasad, President, Quality Operations at Bharat Biotech.
Frequently Asked Questions
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.
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.
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.
Prasad said the company is exploring possibilities of manufacturing Covaxin at partner sites through technology transfer agreements.
The company is also in talks with other partners and looking at possibilities of manufacturing the vaccine in 4-5 countries. It is looking at having at least 1 billion doses per annum manufacturing capacity of Covaxin.
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