The federal government has reached a deal worth up to $ 2.1 billion with drug manufacturers Sanofi and GlaxoSmithKline as part of Operation Warp Speed, pushing the Trump administration to have a widely available coronavirus vaccine by early 2021.
The money will go towards clinical trials, increasing the production and purchase of 100 million doses of the vaccine.
This is the sixth vaccine candidate to join Operation Warp Speed 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 collected for Operation Warp Speed increases the chances 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. announced the agreement.
However, the Sanofi / GSK vaccine candidate is not as long in the research process as some of the others, a small proportion of whom are already in the 3rd phase of 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 show that the vaccine is safe and effective, companies may 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, especially as the federal government – and taxpayers – have provided significant funding for research and development.
“We are committed to making every vaccine developed through this affordable collaboration and through mechanisms that provide fair access for all people,” GlaxoSmithKline CEA CEO Emma Walmsley said in April. The company said it “does not expect to benefit from our collaborative portfolio of COVID-19 vaccines during this pandemic”.
Sanofi plans to restore potential vaccine profits back to coronavirus research and production capabilities, according to a company spokesman. Alsoshtë also committed to “affordable” prices for countries for the “duration of the pandemic phase”.
If approved, 100 million doses of the vaccine would be available to Americans at no cost, according to the Department of Health and Human Services. However, health care providers may charge for the administration of 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.