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COVID-19 vaccine | SII, Bharat Biotech applications for emergency approval 'not considered' in expert panel meeting: Report

The SEC has asked for updated factsheet and prescribing information from SII and more data from Bharat Biotech.

December 30, 2020 / 07:24 PM IST
The development comes hours after the UK gave its go-ahead to the Oxford University-AstraZeneca COVID-19 vaccine.

The development comes hours after the UK gave its go-ahead to the Oxford University-AstraZeneca COVID-19 vaccine.

Applications of Bharat Biotech and Serum Institute of India (SII) for emergency approval of their respective COVID-19 vaccines were "not considered" during a meeting of the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) on December 30, CNBC TV-18 has reported.

According to the report, the SEC has sought more information from both the companies. While the expert panel has asked for updated factsheet and prescribing information from SII, it has asked for more data from Bharat Biotech, sources told the news channel.

The development comes hours after the UK gave its go-ahead to the Oxford University-AstraZeneca COVID-19 vaccine.

Track this LIVE Blog for all the latest updates on coronavirus pandemic

SII is developing the vaccine in India, and had earlier said it was hoping for the emergency use approval by the end of this month or January in India.


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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The government was yet to place a purchase order for the Covishield vaccine, Cyrus Poonawalla, chairman of Poonawalla Group that includes SII, said.

"SII is ready to distribute the vaccine once the approval comes in. India will come first, then other countries," he added.

Read | AstraZeneca/Oxford vaccine: 5 things to know about landmark UK vaccine

The Oxford vaccine was being evaluated by the British regulator - the Medicines and Healthcare products Regulatory Agency (MHRA) - after the final cut of data was submitted by the government last week.

While the vaccination drive is already in process in the UK after regulators gave similar emergency authorization to a vaccine from US drugmaker Pfizer and German partner BioNTech on December 2, the emergency approval in India comes a day after the government carried out successful vaccination dry run. 

The government has identified 300 million people, including healthcare workers, policemen, and citizens above the age of 50, who would be administered a vaccine on a priority basis.

According to officials, more than 154,000 healthcare workers have been identified to help conduct the vaccination drive and the country had enough cold chain capacity to innoculate the first 30 million people.

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