The federal government has reached a deal worth up to $2.1 billion with drugmakers Sanofi and GlaxoSmithKline as part of Operation Warp Speed, the Trump administration's push to have a coronavirus vaccine widely available by early 2021.
The money will go toward clinical trials, scaling up manufacturing and purchasing 100 million doses of the vaccine.
This is the sixth vaccine candidate to join Operation Warp Speed's portfolio, and the largest vaccine deal to date. The federal government has also made deals with AstraZeneca, Johnson & Johnson, Moderna, Novavax and Pfizer.
"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," HHS Secretary Alex Azar said in a written statement announcing the deal.
However, the Sanofi/GSK vaccine candidate is not as far along in the research process as some of the others, a handful of which are already in Phase 3 clinical trials. So far, the Sanofi/GSK vaccine 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 the vaccine is safe and effective, the companies could seek Food and Drug Administration approval sometime in the first half of 2021.
Pharmaceutical companies have been under pressure to keep COVID-19 therapies and vaccines affordable, particularly when the federal government — and taxpayers — have offered substantial funding toward research and development.
"We're committed to making any vaccine that is developed through this collaboration affordable and through mechanisms that offer fair access for all people," GlaxoSmithKline CEO Emma Walmsley said in April. The company said it "does not expect to profit from our portfolio of collaborations for COVID-19 vaccines during this pandemic."
Sanofi plans to reinvest potential vaccine profits back into coronavirus research and manufacturing capacity, according to a company spokesperson. It is also committed to "affordable" pricing to countries for the "duration of the pandemic phase."
If approved, the 100 million doses of this vaccine will be available to Americans at no cost, according to the announcement by the Department of Health and Human Services. However, health care providers could charge to administer the vaccine.
The companies also announced a deal with the United Kingdom for 60 million doses of the vaccine on Wednesday, but the value of the deal was not disclosed.