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COVID-19 vaccine: Expert panel to review Pfizer, Serum, Bharat Biotech's emergency use applications today

After evaluation, the panel will recommend to the DCGI whether emergency use approval for the vaccine candidates should be granted or not.

December 10, 2020 / 05:21 PM IST

A Central Drugs Standard Control Organisation (CDSCO) expert panel meeting on December 9 to review applications of Pfizer, Serum Institute of India (SII) and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccine candidates.

The decision was taken after the Hyderabad-based Bharat Biotech became the third pharmaceutical firm to seek the Drugs Controller General of India (DCGI) nod for emergency use authorisation for its indigenously developed COVID-19 vaccine Covaxin.

Click here for LIVE updates on coronavirus pandemic

"Several points would be discussed in the meeting—for one, Bharat Biotech had changed its dosage during the trial. It had come to seek approval for the same. We will be reviewing this bit very carefully," sources told Business Standard.

Bharat Biotech changed the Covaxin dosage from 3 micrograms of antigen to 6 micrograms during the trial.

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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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Explained: What is emergency use approval, why is it done, how is it done, grey areas, and more

The Indian arm of the US pharmaceutical giant Pfizer on December 4 sought approval for its vaccine from the drug regulator after the firm secured clearance in the UK and Bahrain.

The UK became the first country in the world to began immunizing its citizens against the viral disease when it rolled out Pfizer's vaccine on December 8.

The Pune-based Serum Institute of India sought the nod for the Oxford COVID-19 vaccine, Covishield, on December 6.

Follow Moneycontrol's COVID-19 Vaccine Tracker here

After evaluation, the Subject Expert Committee (SEC) will give its recommendations to the DCGI on whether emergency use approval for the vaccine candidates should be granted.

Three COVID-19 vaccines—developed by Bharat Biotech, Serum Institute of India and Pfizer—were under active consideration of India's drug regulator and an early licence was possible for all or any of them, NITI Aayog member (Health) VK Paul said on December 8.

The same day, the Health Ministry released the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC)'s recommendation on prioritised population groups that need to be administered the vaccine first.

Read: Centre Releases List of People On Priority List for COVID-19 Vaccination: Here's Who Will Get A Shot First

According to the recommendation, more than one crore healthcare providers and workers in both private and public hospitals would be administered the vaccine.

Frontline workers, including personnel from state and central police, armed forces, home guards, civil defence and disaster management volunteers and municipal workers, will be administered a shot when it becomes available.

Click here for Moneycontrol's full coverage of the COVID-19 outbreak
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