Sanofi is aiming to manufacture hundreds of millions of doses of the coronavirus (SARS-COV-2) vaccine it is working on with GSK and BARDA and is targeting a late 2021 launch.

Sanofi and GSK announced the deal on Tuesday, explaining they signed a letter of intent and a materials transfer agreement to assess the technical path to develop and produce a COVID-19 pandemic vaccine.

Sanofi spokeswoman Marion Breyer said “Our goal is to initiate Phase I clinical trials in the second half of 2020 and, subject to regulatory considerations, complete the development required for availability in the US and Europe by the second half of 2021.

Partnerships in the time of coronavirus. Image iStock/Ablozhka

“While it is difficult to commit to an exact number of doses, our expectation is to be able to produce hundreds of millions of doses of the vaccine. This of course is dependent upon positive clinical trials and regulatory approvals.”

Recombinant manufacturing

The vaccine is based on a version of the SARS-COV-2 S-protein produced by Sanofi using its baculovirus expression platform, which is the same technology used to make the firms recombinant influenza product, Flublok.

Development is being supported by the Biomedical Advanced Research and Development Authority (BARDA), part of the office for preparedness and response at the US Department of Health and Human Services.

GSK will make its adjuvant AS03 available for use in advancing non-clinical and clinical work according to Breyer, who told us “The partnership with GSK supports the recombinant DNA protein-based approach, as we will be testing the adjuvant with our recombinant protein.

“The adjuvant will be used in these studies to boost the vaccine response, with the aim to be dose-sparing so more vaccine can be made available. The companies intend to negotiate a license and supply agreement related to AS03 for application in a pandemic.”

Availability

How health care systems and the general population will access Sanofi’s vaccine has yet to be decided.

Breyer said, “It is premature to speculate on, much less set, a price for a vaccine until we have a much clearer understanding about the impact COVID-19 may have on global public health, including how it may spread or whether it will naturally slow or disappear.”

“Should our efforts prove to be a safe and effective preventative measure against COVID-19, we will work with health authorities, payers and governments around the world to ensure timely and affordable access to those who need it.

She added “We have demonstrated our commitment to global access in the past, and, if we bring a COVID-19 vaccine to patients, we intend to do so for it as well. We do not know enough about COVID-19 to determine if there will be a commercial market for the vaccine.”

The collaboration is the second SARS-CoV2 vaccine development effort Sanofi has announced.

In March the French drug firm extended an existing partnership with Translate Bio to include the development of an mRNA-based jab that protects against the virus.