The federal government has reached an agreement worth up to $ 2.1 billion with drug producers Sanofi and GlaxoSmithKline as part of Operation Warp Speed, the Trump administration that pushed for a widely available coronavirus vaccine until early 2021.
The money goes to clinical trials, which expand manufacturing and buy 100 million doses of the vaccine.
This is the sixth vaccine candidate to join Operation Warp Speed’s portfolio, and the largest vaccination deal to date. The federal government has also entered into agreements with AstraZeneca, Johnson & Johnson, Moderna, Novavax and Pfizer.
“The vaccine portfolio being set up for Operation Warp Speed increases the likelihood that we will have at least one safe and effective vaccine by the end of this year,” HHS Secretary Alex Azar said in a statement in writing announcing the agreement.
However, the candidate for the Sanofi / GSK vaccine is not as far behind in the research process as some others, a small number of whom are already in Phase 3 clinical trials. Sanofi / GSK has only been studied in preclinical trials.
Human studies for the Sanofi / GSK vaccine candidate are expected to begin in September. If the data shows that the vaccine is safe and effective, companies can seek Food and Drug Administration approval sometime in the first half of 2021.
Pharmaceutical companies have come under pressure to keep COVID-19 therapies and vaccines accessible, particularly when the federal government – and taxpayers – have offered substantial funding toward research and development.
“We are committed to making any vaccine that is developed through this affordable collaboration and through mechanisms that offer fair access to all people,” GlaxoSmithKline CEO Emma Walmsley said in April. The company said it “does not expect to benefit from our portfolio of collaborations for COVID-19 vaccination during this pandemic.”
Sanofi plans to reinvest the potential profits of the vaccine back into coronavirus research and manufacturing capacity, according to a company spokesman. It is also committed to “affordable” prices for countries for the “duration of the pandemic phase.”
If approved, the 100 million doses of this vaccine will be available to Americans free of charge, according to news from the Department of Health and Human Services. However, health care providers may charge a fee to administer the vaccine.
The companies also announced a deal with the UK for 60 million doses of the vaccine on Wednesday, but the value of the deal was not disclosed.