GSK, Sanofi to provide 300 million doses of COVID-19 vaccine to EU
A Phase 3 study is planned to begin by the end of 2020 and regulatory approval could be requested in the first half of 2021.
Paris: Sanofi and GlaxoSmithKline (GSK) have recently announced that they have finalized and signed an Advanced purchase agreement with the European Commission (EC) for the supply of up to 300 million doses of a COVID-19 vaccine, once the vaccine is approved.
The vaccine candidate is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK's established adjuvant technology. This final agreement confirms the announcement made on July 31 by both companies and marks a key milestone in protecting European populations against COVID-19.
The contract will allow the purchase of a vaccine against COVID-19 for all Member States of the European Union (EU), which may donate reserved doses to lower- and middle-income countries. The EU will provide upfront funding to support the scale-up of Sanofi and GSK manufacturing capabilities on European soil. The antigen and final vaccine doses will be manufactured in European countries, leveraging Sanofi and GSK's industrial sites in Belgium, Italy, Germany and France.
The Companies announced the launch of its Phase 1/2 clinical study in support of the vaccine's development on September 3rd. A Phase 3 study is planned to begin by the end of 2020 and regulatory approval could be requested in the first half of 2021. Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant with the intent to produce up to one billion doses per year overall to help meet high and urgent demand for vaccines worldwide.
Elsewhere, Sanofi and GSK recently signed agreements with the United States where they have longstanding partnerships with the Biomedical Advanced Research and Development Authority, and also with the UK Government.
The partners plan to provide a significant portion of total worldwide available supply capacity to the global initiative "Access to COVID‐19 Tools (ACT) Accelerator," a global collaboration of leaders of governments, global health organizations, businesses and philanthropies to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines.
In addition to the recombinant protein-based vaccine in collaboration with GSK, Sanofi is developing a messenger RNA (mRNA) vaccine in partnership with Translate Bio. With several innovative vaccine platforms currently being investigated across the industry, mRNA is considered among the most promising. Preclinical data have shown that two immunizations of the mRNA vaccine induced high neutralizing antibody levels that are comparable to the upper range of those observed in infected humans.
Sanofi expects the Phase 1/2 study to start in November, with earliest potential approval in the second half of 2021. Translate Bio has established mRNA vaccine manufacturing capacity and Sanofi expects to be able to supply annual capacity of 90 to 360 million doses.
