Sanofi, GSK get approval to conduct phase 3 trial of COVID-19 vaccine in India

In a two-stage approach, the phase 3 clinical study will initially investigate the efficacy of the COVID-19 vaccine formulation targeting the original novel coronavirus strain.

Moneycontrol News

July 13, 2021 / 19:17 IST

File image: French President Emmanuel Macron listens to a researcher as he visits an industrial development laboratory at French drugmaker's vaccine unit Sanofi Pasteur plant near Lyon, France on June 16, 2020 (Image: Laurent Cipriani/Pool via Reuters)

Sanofi and GSK have received the drug regulator's nod to conduct the phase 3 clinical trial of their COVID-19 vaccine in India. The study will assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein vaccine candidate.

"India is participating in Sanofi Pasteur's pivotal phase 3 study, and subject to subsequent approvals, we should soon begin enrollment of study participants in the country," said Annapurna Das, Country Head, Sanofi Pasteur India.

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The global, randomised, double-blind phase 3 study will include more than 35,000 volunteers aged 18 and older across sites in the United States, Asia, Africa and Latin America, news agency PTI quoted Sanofi as saying in a statement.

As the novel coronavirus continues to evolve, "we are anticipating what will be needed in the coming months and years, and accordingly, have adapted our vaccine development program," Das added.

COVID-19 Vaccine

Frequently Asked Questions

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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