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SEC recommends in favour of EUA for Bharat Biotech's COVID-19 vaccine candidate

The Subject Expert Committee of the Central Drugs Standard Control Organisation reportedly recommended granting emergency use authorisation to the COVID-19 vaccine developed by Bharat Biotech.

January 03, 2021 / 08:00 IST
File image: A ground staff walks past a container kept at the Cargo Terminal 2 of Delhi's Indira Gandhi International Airport, which according to the officials will be used as a COVID-19 vaccine handling and distribution center. (Image: Reuters/Anushree Fadnavis)

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), on January 2, recommended granting emergency use authorisation to the COVID-19 vaccine developed by Bharat Biotech, news reports suggest.

Sources told CNBC-TV18 that SEC recommended in favour of Emergency Use Authorisation  (EUA) for the Indian Bharat Biotech COVID-19 vaccine candidate.

This came a day after the SEC reportedly recommended conditional use of the Serum Institute of India (SII)'s COVID-19 vaccine.

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The next step would be for the regulator to actually grant the EUA. This would pave the way for Indian authorities to start vaccinating the masses. The government has planned vaccination of 25-30 crore people by July.

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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Healthcare and frontline workers will be given priority. More than 70 lakh healthcare workers have already been registered on the purpose-built Co-WIN platform.

The dry run for this exercise was carried out in four states on December 28, 2020. Another round was conducted across all states and Union Territories on January 2.

COVID-19 Vaccine Tracker: All you need to know about manufacturing and pricing

SII, Bharat Biotech and Pfizer had applied to the DCGI seeking emergency use authorisation for their COVID-19 vaccine candidates. The SEC on COVID-19 had on December 30 deliberated and analysed additional data and information submitted by SII and Bharat Biotech.

As of January 2, India had reported more than 1.03 crore confirmed COVID-19 cases. The death toll from the outbreak in the country stood at 1.49 lakh. While more than 99.06 lakh patients had recovered, 2.50 lakh cases remained ‘active’. Globally, more than 8.3 crore individuals have been infected by the virus and over 18.2 lakh people have died so far.

A speedy rollout of vaccines is being seen as the best way to curb the spread of COVID-19 and restore normalcy in the pandemic-hit global economy. As many as 50 countries, including the United States and the United Kingdom, have already granted emergency use authorisation to multiple COVID-19 vaccines and have started vaccinating high-risk groups.

Prime Minister Narendra Modi said on December 30, 2020 that people should not let their guard down and strictly abide by safety protocols even after vaccination. “I used to say 'jab tak davai nahi, dhilai nahi (no carelessness until we have a medicine)', but now our mantra for 2021 should be: ‘davai bhi, kadaai bhi (yes to medicine, yes to caution),” PM Modi said.

The prime minster also said that preparations for the vaccination programme in India were in final stages and added that people will be given doses of vaccines manufactured in the country.

Serum Institute has already stockpiled 7.5 crore doses of Covishield and will be increasing it to 10 crore units by the first week of January.

Click here for Moneycontrol’s full coverage of the coronavirus pandemic

Moneycontrol News
first published: Jan 2, 2021 06:17 pm

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