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The federal government has reached an agreement of up to $ 2.1 billion with drug makers Sanofi and GlaxoSmithKline as part of Operation Warp Speed, the Trump administration’s push to have a widely available coronavirus vaccine in early 2021.
The money will go to clinical trials, increasing the manufacture and purchase of 100 million doses of the vaccine.
It is the sixth vaccine candidate to join the Warp Speed operations portfolio and the largest vaccine offering to date. The federal government has also agreed with AstraZeneca, Johnson & Johnson, Moderna, Novavax and Pfizer.
“The vaccine portfolio being put together for Operation Warp Speed increases the chances that we will have at least one safe and effective vaccine as early as the end of this year,” HHS Secretary Alex Azar said. in a statement announcing the deal.
However, the Sanofi / GSK vaccine candidate is not so far in the research process as some others, a good handful of whom are already in phase 3 clinical trials. So far, the Sanofi / GSK vaccine 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 show that the vaccine is safe and effective, companies could apply for Food and Drug Administration approval in the first half of 2021.
Pharmaceutical companies have been under pressure to make COVID-19 therapies and vaccines affordable, especially when the federal government – and taxpayers – have provided significant funding for research and development.
“We are committed to making any vaccine developed through this collaboration affordable and through mechanisms that provide fair access to all people,” Emma Walmsley, CEO of GlaxoSmithKline, said in April. The company said it “does not expect to benefit from our portfolio of collaborations for COVID-19 vaccines during this pandemic.”
Sanofi plans to reinvest the potential benefits of the vaccine in coronavirus manufacturing and research capacity, according to a company spokesman. It also bets on an “affordable” price for 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 Department of Health and Human Services announcement. However, healthcare providers could charge for administering the vaccine.
Companies also announced an agreement with the UK for 60 million doses of the vaccine on Wednesday, but the value of the deal was not disclosed.