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GSK says exploring all options to make COVID-19 antibody drug Sotrovimab available in India quickly

Treatment with Sotrovimab resulted in an 85 percent reduction in the risk of hospitalisation or death in high-risk adult COVID-19 outpatients compared to placebo, based on interim results from Phase 3 COMET-ICE trial.

May 27, 2021 / 10:14 IST
Glaxosmithkline Pharmaceuticals | The company reported consolidated profit at Rs 156.5 crore in Q3FY21 against loss of Rs 661.16 crore in Q3FY20, revenue rose to Rs 857.20 crore from Rs 778.6 crore YoY.
     
     
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    GSK and Vir Biotechnology on May 26 announced that USFDA granted Emergency Use Authorisation (EUA) of Sotrovimab (previously VIR-7831), for treatment of mild-to-moderate COVID-19 in high-risk adults and paediatric patients

    Treatment with Sotrovimab resulted in an 85 percent reduction in the risk of hospitalisation or death in high-risk adult COVID-19 outpatients compared to placebo, based on interim results from the Phase 3 COMET-ICE trial.

    GlaxoSmithKline (GSK) said it plans to make monoclonal antibody Sotrovimab available in India quickly.

    Also Read: What is antibody cocktail drug, how it works, pricing and more

    In vitro data indicate Sotrovimab maintains activity against all known variants of concern, including variant B.1.617 from India.

    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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    “We are exploring all options to quickly make this important medicine available for Indian patients ” GSK India spokesperson told Moneycontrol.

    GSK said it is in discussions with global regulators regarding authorisations in additional countries that continue to advance.

    “Our distinctive scientific approach has led to a single monoclonal antibody that, based on an interim analysis, resulted in an 85 percent reduction in all-cause hospitalisations or death, and has demonstrated, in vitro, that it retains activity against all known variants of concern, including the emerging variant from India," said George Scangos,  Chief Executive Officer of Vir.

    "I believe that Sotrovimab is a critical new treatment option in the fight against the current pandemic and potentially," Scangos added.

    Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said the fast pace of COVID-19 vaccinations in the US is encouraging, yet, despite these aggressive efforts, there is still a need to help prevent infected patients from developing complications.

    "In just over a year since starting our collaboration and in less than 10 months since beginning clinical trials, we are delighted that, as of today, the benefits of this unique monoclonal antibody will now be available to patients in need for future coronavirus outbreaks," Barron said.

    Viswanath Pilla
    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: May 27, 2021 10:13 am

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