Sanofi in the firing line over ‘US-first’ COVID-19 vaccine plan

Sanofi is facing a backlash in France and elsewhere after the company’s CEO Paul Hudson said that the US would be first in line for its experimental coronavirus vaccine if approved for use.

Hudson made the comment in an interview with Bloomberg earlier this week, suggesting that because the federal government in the US had invested in the programme – via Biomedical Advanced Research and Development Authority (BARDA) funding – it “had the right to the largest pre-order”.

The dollar value of that support isn’t clear, but critics have also pointed out that Sanofi has benefited from tax credits on its R&D from the French government for many years.

The company is now backtracking, with Sanofi’s chairman Serge Weinberg saying that it will ensure equal access to everyone to the vaccine, with no particular advantage for any one country. He told France 2 television that Hudson’s words had been taken out of context.

The furore has reached the highest levels of French politics, with President Emmanuel Macron reportedly seeking a meeting with Sanofi next week to discuss the matter, and Prime Minister  Edouard Philippe going on record to say that equitable access is “non-negotiable”.

Philippe later said that he had spoken to the company and received “assurances” over the roll-out of the vaccine if it is shown to work in clinical trials. It is expected to start human tests in the second half of 2020 and to be available by the second half of 2021 if it works.

The situation is indicative of the tightrope that companies will have to walk when it comes to access – and pricing – of drugs and vaccines that are shown to have a role in managing COVID-19, particularly in the early stages when production capacity may be restricted.

Sanofi’s vaccine is one of more than 100 that have been put into development around the world, with eight candidates already in clinical trials according to the World Health Organization.

Furthest ahead is an adenovirus type 5-based candidate developed by China’s CanSino Biological and the Beijing Institute of Biotechnology – which is in phase 2, a little ahead of Moderna’s mRNA-based candidate and three Chinese inactivated virus vaccines, all three of which are in phase 1/2 studies.

Another adenoviral vaccine developed by the University of Oxford and partnered with AstraZeneca is in phase 1/2 testing in the UK. Meanwhile, Pfizer/BioNtech’s mRNA-based candidate has started a phase 1/2 trial in Germany and the US, and US biotech Inovio Pharma has a DNA plasmid-based candidate in phase 1.

Sanofi’s vaccine candidate is based on a recombinant DNA platform that can produce an exact genetic match to proteins found on the surface of the virus, according to the company.

Those sequences are then spliced into a baculovirus expression platform to allow large quantities of the antigens to be created for formulation onto a vaccine, a technique the company already uses for its influenza shots.