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COVID-19 vaccine | Sanofi to seek permission for Phase 3 trial in India: Report

Sanofi is looking to conduct a part of its 35,000-participant global Phase 3 trial of its COVID-19 vaccine in India.

July 07, 2021 / 09:12 IST
Sanofi has partnered with British pharmaceutical giant GlaxoSmithKline (GSK) to develop an adjuvanted recombinant-protein COVID-19 vaccine candidate.

Sanofi has partnered with British pharmaceutical giant GlaxoSmithKline (GSK) to develop an adjuvanted recombinant-protein COVID-19 vaccine candidate.

French drugmaker Sanofi is working on getting approval from the Drugs Controller General of India (DCGI) to conduct Phase 3 trial of its COVID-19 vaccine in the country.

Sanofi is looking to conduct a part of its 35,000-participant global Phase 3 trial of the jab in India, Mint has reported.

"Applications are being made to the regulator. The batches for clinical trial have to undergo testing at CDL (Central Drugs Laboratory) in Kasauli and the DCGI's approval has to be got soon before the trial begins," a source told the publication.

Moneycontrol could not independently verify the story.

"Sanofi is currently assessing a broad mix of clinical sites in several countries to participate in our phase 3 study. Recruitment has already started in the US and we expect to bring several countries on board in the coming weeks," a spokesperson for Sanofi told Mint.

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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"This phase 3 trial is expected to enrol more than 35,000 adult participants from several countries across the world," the spokesperson said.

Sanofi has partnered with British pharmaceutical giant GlaxoSmithKline (GSK) to develop an adjuvanted recombinant-protein COVID-19 vaccine candidate.

The company plans to initiate the recruitment process for the trial in several countries in Asia, Africa and Latin America in the coming weeks, the report said.

Moneycontrol News
first published: Jul 7, 2021 09:12 am

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