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French pharma giant Sanofi plans to conduct a part of the 35,000-participant global phase 3 trial in India for the covid vaccine it is developing with UK firm GlaxoSmithKline (GSK).

The company is in the process of getting approval from the Drugs Controller General of India (DCGI) to conduct the phase 3 trial. If it gets approval, it will be the first global trial for a foreign covid vaccine in India, two people aware of the company’s plans said.

“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," one of the persons mentioned above said.

The partnership between Sanofi and GSK is unprecedented in the global pharma industry. Sanofi, which is leading the trial, and its British partner had already started recruiting participants for its phase 3 trial in the US in late May and have plans to initiate the process in several countries in Asia, Africa and Latin America in the coming weeks.

“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. This phase 3 trial is expected to enrol more than 35,000 adult participants from several countries across the world," a spokesperson for Sanofi Pasteur said in a statement to Mint.

Sanofi’s choice of India is possibly because despite the surge during the second wave between March and May, a little more than 30 million people—less than 3% of the population—have been confirmed to have had covid so far. This number is widely considered to have been undercounted, but there may still be a significant proportion of unvaccinated population, especially in semi-urban and rural areas, without prior exposure to the virus.

“I think there are still significant populations of uninfected people. Also, the fact that another wave in India is impending means the phase 3 trial (of Sanofi) will be able to accrue covid cases quickly, leading to a faster readout," said Davinder Gill, a vaccine expert in Massachusetts, US.

Sanofi aims to prevent covid in unvaccinated adults who have not been infected earlier and also plans to conduct a parallel global study with various variant formulations to assess the ability of a lower dose to generate a strong booster response in people who have already received another vaccine.

A phase 2 study of the vaccine conducted on 722 participants in the US and Honduras earlier this year showed that in people already infected, a single dose of the vaccine showed high titres of antibodies, which the company said suggests the vaccine may have strong potential for use as a booster dose.

The study also showed that the vaccine triggered a strong immune response among adults, with neutralizing antibodies comparable to those generated by natural infection.

Sanofi’s and GSK’s jointly-developed vaccine is based on the protein subunit platform. Its main component is spike proteins from the original coronavirus strain first found in Wuhan and the beta variant B.1.351 first found in South Africa to trick the immune system into producing antibodies. This has been developed by Sanofi. The adjuvant used to boost the immune response has been developed by GSK. Two doses of the vaccine are given 21 days apart.

The trial will study the prevention of symptomatic covid, while the secondary endpoint will look at prevention of severe covid and prevention of asymptomatic infection.

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