Sanofi and GlaxoSmithKline announced that the US government will provide more than $2.1 billion to support further development, manufacturing and delivery of initial doses of the companies’ adjuvanted vaccine against COVID-19. The vaccine candidate is based on Sanofi’s recombinant protein-based technology and GlaxoSmithKline’s pandemic adjuvant technology.
The drugmakers, which disclosed their partnership in April, noted that more than half of the money will support further development of the vaccine, including clinical trials. Sanofi is leading development of the vaccine and expects a phase I/II study to start in September, followed by a phase 3 trial before the end of the year. The French company indicated that the funds will be paid out based on hitting certain milestones.
The remainder of the money will be used for manufacturing scale up and delivery of an initial 100 million doses of the vaccine as part of the US government’s Operation Warp Speed program. In addition, the government has a further option for the supply of an additional 500 million doses longer term.
Sanofi and GlaxoSmithKline recently reached an agreement with the UK government for the supply of up to 60 million doses of the vaccine. The companies said Friday that discussions with the European Commission, with France and Italy on the negotiation team, are ongoing, as well as talks with other governments.
However, a recent report suggested that Sanofi’s talks with the European Commission over the supply of 300 million doses of the vaccine have stalled over disagreements related to payment. Sources suggested that the French drugmaker wants an upfront payment, while the European Commission is seeking to pay in tranches and delay some payments until the vaccine has passed large clinical trials.
US supplies continue to mount
“The portfolio of vaccines being assembled for Operation Warp Speed increases the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” remarked Alex Azar, secretary of the Department of Health and Human Services (HHS). Earlier in July, the US government agreed to pay $1.95 billion for an initial order of 100 million doses of BNT162, an mRNA-based COVID-19 vaccine candidate being jointly developed by Pfizer and BioNTech.
The government also awarded $1.6 billion to Novavax to progress development of NVX CoV2373 and potentially deliver 100 million doses of the COVID-19 vaccine as early as late 2020. Meanwhile, in May, the Biomedical Advanced Research and Development Authority, an office within HHS, agreed to supply $1.2 billion in funding to secure at least 300 million doses of AstraZeneca and the University of Oxford’s COVID-19 candidate vaccine AZD1222, starting as early as October.