Aurobindo Pharma hopes to submit Phase 2/3 data of UB-612 COVID-19 vaccine by July 2021

Aurbindo has sought permission from Indian drug regulator CDSCO to conduct Phase-2/3 trial of the vaccine candidate in India, as the animal studies and Phase-I clinical trial were conducted in Taiwan.

February 19, 2021 / 07:31 PM IST
Representative image: Reuters

Representative image: Reuters

 
 
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Aurobindo Pharma has said it expects to submit clinical trial data of its COVID-19 vaccine UB-612 by July this year. The drugmaker had entered into an exclusive agreement with US biotech company COVAXX in December last year to develop and manufacture UB-612 for India and UNICEF.

Aurbindo has sought permission from Indian drug regulator CDSCO to conduct Phase-2/3 trial of the vaccine candidate in India, as the animal studies and Phase I clinical trial were conducted in Taiwan.

However, the Subject Expert Committee (SEC) of CDSCO which reviewed Aurbindo's proposal on February 3 recommended that the firm should submit the Phase II/III clinical

trial protocol approved by the regulatory authority of Brazil. It also suggested some revisions to the protocol. It is not known whether Aurobindo has resubmitted its proposal or not.

"We are expecting to submit the data by July. And then we expect approval in the next financial year," said N Govindarajan, Managing Director of Aurobindo Pharma, in a recent earnings call.

Aurobindo said it is investing Rs 250-Rs 275 crore on a new facility to manufacture vaccines that would be ready by April. The company’s upcoming vaccine facility will have the capacity to manufacture 400 - 450 million doses of COVID-19 vaccines.

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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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The company said it is exploring collaboration with potential partners who are getting ready with their products.

"If you're talking about FY '22, definitely, we expect to utilise the facility for COVID vaccine. So when I talk about contract manufacturing, after accounting for whatever our needs, whatever is the available capacity, we'll explore for the future.. and also our own arrangement with COVAXX also allows us to do some contract manufacturing for them," Govindarajan said.

Aurobindo said that it has the capabilities to manufacture most virus vector platforms, including mRNA and DNA technologies; mRNA stands for Messenger RNA.

Aurobindo has announced its own COVID-19 vaccine development programme through its US subsidiary Auro Vaccines. That vaccine, which uses a recombinant vesicular stomatitis virus (RVSV) vector platform, is being developed by Profectus BioSciences, which was acquired by Aurobindo Pharma in November last year. This vaccine is still in the pre-clinical phase.

Aurobindo has also partnered with three CSIR labs – Centre for Cellular and Molecular Biology (CCMB), Hyderabad, Institute of Medical Technology (IMTECH), Chandigarh, and the Indian Institute of Chemical Biology (IICB), Kolkata, for vaccine candidates using three different technology platforms. Aurobindo will undertake the clinical development and commercialisation of these vaccines.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Feb 19, 2021 07:30 pm

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