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HomeNewscoronavirusCOVID-19 vaccine | Expert panel to take up Pfizer, SII's emergency use authorisation applications soon

COVID-19 vaccine | Expert panel to take up Pfizer, SII's emergency use authorisation applications soon

Pfizer was the first to apply for the EUA in India on December 5. However, it sought more time from the Subject Expert Committee (SEC) as its experts were busy and could not present their case on December 9.

December 22, 2020 / 17:58 IST
Pfizer's COVID-19 vaccine is awaiting nod of central agencies for emergency use in India.
     
     
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    The Central Drugs Standard Control Organization's expert panel will meet soon to take up the applications of Pfizer and Serum Institute of India (SII) for the emergency use authorisation (EUA) for their COVID-19 Vaccine candidates, sources told CNBC-TV18 on December 22.

    Notably, Pfizer was the first to apply for the EUA in India on December 5. However, it sought more time from the Subject Expert Committee (SEC) as its experts were busy and could not present their case on December 9.India reviewing Pfizer’s emergency use application, detailed plans in place for vaccination programme: Health Minister Harsh Vardhan

    Now, the US pharma giant has written to the drug controller seeking a fresh date to present their case for the EUA.

    The SII, on the other hand, had sought permission from the SEC to conduct phase III trials of COVOVAX in India as it has already conducted phase I and II trials of the vaccine candidate in the US.

    However, the expert panel told SII to conduct phase two human clinical trials of COVOVAX in India before moving on to the third stage.

    COVID-19 Vaccine

    Frequently Asked Questions

    View more
    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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    Moneycontrol News
    first published: Dec 22, 2020 05:22 pm

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