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COVID-19 vaccine | Panel recommends emergency use authorisation for SII's Covishield 'with conditions'

The SII, Bharat Biotech and Pfizer have applied to the DCGI seeking emergency use authorisation for their COVID-19 vaccine candidates.

January 02, 2021 / 07:16 AM 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)

An expert panel of the Central Drugs Standard Control Organisation (CDSCO) on January 1 recommended emergency use authorisation (EUA) "with conditions" for Serum Institute of India's (SII) Covishield vaccine, CNBC TV-18 reported quoting sources.

The Subject Expert Committee (SEC) has recommended in favour of the EUA approval to the Drugs Controller General of India (DCGI) for SII's Vaccine, according to the news channel. The DCGI receives recommendations from the SEC.

Sources said that the expert panel did not approve Covaxin and asked Bharat Biotech to present more data. News agency PTI reported that it also asked the company to expedite volunteer recruitment and recommended interim efficacy analysis for Covaxin.

Earlier, the Health Ministry had tweeted that a final decision will be taken by the DCGI.

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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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The SEC on COVID-19 had on December 30 deliberated and analysed the additional data and information submitted by SII and Bharat Biotech.

SII, Bharat Biotech, and Pfizer have applied to the DCGI seeking emergency use authorisation for their COVID-19 vaccine candidates.

Read: COVID-19 vaccination drive: Over 70 lakh healthcare workers registered on Co-WIN platform

Dr Vinod K Paul, Head of the National COVID-19 Task Force told the news channel that broadly dosing guidelines are likely to be similar to United Kingdom (UK) approval, which is to say 4-12 weeks.

He added that there are 31 hubs to supply vaccines to all the states and that India will "pitch for 300 million individuals".

"Bharat Biotech vaccine is a very promising vaccine... Expert group will take a call with respect to its review," Paul told the news channel in an exclusive interview.

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

Regarding the news of the recommendation, Dr Paul said that it's a "great day" if indeed the development has taken place.

Six vaccines are at various stages of clinical trials, of which four are being indigenously developed.

The clinical trials by Bharat Biotech are in phase 3, while the one which is being developed by Zydus Cadila is in phase 2 clinical trial.

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

The government has identified priority beneficiaries of the vaccine and over 70.33 lakh frontline healthcare workers have been registered on the Co-WIN platform. The government is planning to inoculate them in the first phase of the coronavirus vaccination drive.

To vaccinate the beneficiaries, the government has also identified over 2.30 lakh vaccinators, sources told CNBC-TV18. Additionally, over 51,000 public health facilities have been shortlisted for the vaccine rollout.

dry run for COVID-19 vaccination will be conducted by all state and Union Territory administrations on January 2 to test the linkages between planning and implementation and to identify challenges, the Centre said.

While some states will also include districts that are situated in difficult terrains/have poor logistical support, Maharashtra and Kerala are likely to schedule the dry run in major cities other than their capital, the Union Health Ministry said.

Read: Serum Institute to have 100 million COVID-19 vaccine doses ready by January first week

"The objective of the dry run for COVID-19 vaccine introduction is to assess operational feasibility in the use of Co-WIN application in the field environment, to test the linkages between planning and implementation and to identify the challenges and guideway forward prior to actual implementation. This is also expected to give confidence to programme managers at various levels," the ministry said.
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