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COVID-19 vaccine | After Pfizer, SII, Bharat Biotech seeks emergency use authorisation for its Covaxin

Bharat Biotech's vaccine candidate was in the news recently after Haryana minister Anil Vij, who had volunteered for the trial and was administered a dose, had tested positive for COVID-19.

December 08, 2020 / 07:17 AM IST
the DCGI is likely to make a decision on their applications for emergency approval  in another two weeks.(Image: Reuters)

the DCGI is likely to make a decision on their applications for emergency approval in another two weeks.(Image: Reuters)

After Pfizer and the Serum Institute of India (SII), Hyderabad-based Bharat Biotech has applied to the Drugs Controller General of India (DCGI) for emergency use authorisation of its COVID-19 vaccine, Covaxin, PTI reported.

On December 6, SII had applied to DCGI for emergency use authorisation for AstraZeneca-Oxford COVID-19 vaccine in India.

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Earlier, the Indian arm of US pharmaceutical giant Pfizer had become the first company to seek a similar approval from India's drug regulator for Pfizer/BioNTech vaccine against COVID-19, after securing such clearance in the UK and Bahrain.

Sources also told CNN-News18 that a Subject Expert Committee is likely to meet on December 9 to discuss applications of Pfizer, SII as well as Bharat Biotech.

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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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According to news agency PTI, the Central Drugs Standard Control Organisation (CDSCO) will also meet on December 9 to evaluate their applications.

Bharat Biotech's vaccine candidate was in the news recently after Haryana minister Anil Vij, who had volunteered for the trial and was administered a dose, had tested positive for COVID-19.

Read: Why Haryana Minister Anil Vij Who Volunteered For Bharat Biotech's COVID Vaccine Trial Tested Positive?

Vij was the first volunteer of Covaxin's phase-3 trial in Haryana which started in November. Bharat Biotech is testing the vaccine in a late stage trial on 25,800 volunteers across the country.

As far as the other two candidates are concerned, according to reports, the DCGI is likely to make a decision on their applications for emergency approval  in another two weeks.
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