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COVID-19 vaccine: SEC recommends mix-and-match trial of Covishield and Covaxin

The SEC panel recommended granting permission to Bharat Biotech for carrying out a study on the interchangeability of its Covaxin and the under-trial intranasal vaccine.

July 30, 2021 / 11:07 AM IST
The panel also recommended granting permission to Bharat Biotech for carrying out a study on the interchangeability of its Covaxin and the under-trial adenoviral intranasal vaccine candidate BBV154. (Image Source: Reuters/Jose Cabezas)

The panel also recommended granting permission to Bharat Biotech for carrying out a study on the interchangeability of its Covaxin and the under-trial adenoviral intranasal vaccine candidate BBV154. (Image Source: Reuters/Jose Cabezas)

The Subject Expert Committee (SEC) of the CDSCO (Central Drugs Standard Control Organisation) has recommended granting a nod for a mix-and-match trial of two COVID-19 vaccines -- Covishield and Covaxin.

The panel also recommended granting permission to Bharat Biotech for carrying out a study on the interchangeability of its Covaxin and the under-trial adenoviral intranasal vaccine candidate BBV154.

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It has, however, asked the Hyderabad-based vaccine maker to remove the word "interchangeability" from the study title and submit a revised protocol for approval.

"The SEC (subject expert committee) after detailed deliberations recommended granting permission to CMC, Vellore for conducting the phase-4 clinical trial covering 300 healthy volunteers for mixing of COVID-19 vaccines Covaxin and Covishield," a source told PTI.

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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 aim of the study is to assess whether a person can be given two different vaccine shots -- one each of Covishield and Covaxin -- to complete the inoculation course," the source added.

Also read | Decoding India’s 2021 vaccination challenge

Reviewing the application submitted by Biological E for conducting Phase 2/3 clinical trial of its COVID-19 vaccine in the paediatric population aged 5 to 17 years, the panel asked the firm to submit safety and immunogenicity data (after dose 1) from the ongoing phase 2/3 clinical trial on adults.

"After deliberation, the committee recommended that the safety and immunogenicity data from phase 2 part of the phase 2/3 clinical trial on adults should be submitted to the CDSCO (Central Drugs Standard Control Organisation)," PTI reported, quoting sources.

It also suggested that the firm should submit the clinical trial protocol along with data for further review by the committee, the source said.

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first published: Jul 30, 2021 11:07 am
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