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COVID-19 vaccine | Adar Poonawalla of SII expects AstraZeneca-Oxford covid vaccine approval 'very soon'

The subject expert committee of the Central Drugs Standard Control Organisation, India's drug regulator, is likely to meet later this week to examine SII's emergency-use authorisation (EUA) application for Oxford-AstraZeneca’s vaccine.

December 28, 2020 / 08:30 PM IST
SII has been adding 40-50 million doses every month, and will be reaching production capacity of about 300 million doses by July 2021. (Image Source: Reuters)

SII has been adding 40-50 million doses every month, and will be reaching production capacity of about 300 million doses by July 2021. (Image Source: Reuters)

Serum Institute of India (SII) CEO Adar Poonawalla on December 28 said he was hoping for the emergency use approval of AstraZeneca-Oxford University COVID-19 vaccine 'Covishield' by the end of this month or January in the UK and India.

"The emergency use licensure is expected to come by December or may be January in the UK, and simultaneously we hope to get approval in India as well," Poonawalla told the media.

The subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), India's drug regulator, is likely to meet later this week to examine SII's emergency-use authorisation (EUA) application for Oxford-AstraZeneca’s vaccine.

Oxford COVID-19 vaccine may become the first to get Indian regulator's nod for emergency use

"It is entirely in the purview of the regulator. There is a lot of data coming from global multi-centric trials. It's not reviewing India data, but UK and South Africa data as well," Poonawalla 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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"There are no concerns at all (with the vaccine safety and efficacy), we will be hearing some good news very soon. All the data has been submitted to the UK and Indian regulators. We must respect the process adopted by the regulators," Poonawalla added.

On supply situation

Poonawalla said the company had been adding 40-50 million doses every month, and will be reaching production capacity of about 300 million doses by July 2021.

Poonawalla said 50 percent of the vaccine supplies will go to India, and the rest will go to COVAX. However, during the initial months India would prioritize supplies.

The COVAX advance market commitment was launched on June 4 to ensure rapid, fair, and equitable access to COVID-19 vaccines worldwide. COVAX will enable countries to have access to the world’s largest and most diverse COVID-19 vaccine portfolio.

Poonawalla expects shortages in the first six months, but the supply situation is expected to ease by the middle of next year.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.

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