The US government is set to pay Pfizer and BioNTech nearly $2 billion to manufacture 100 million doses of Covid-19 vaccines by December, if a vaccine is proven safe and effective, Health and Human Services Secretary Alex Azar announced on Wednesday.
German-biotech firm BioNTech and American pharmaceutical company Pfizer are developing a vaccine jointly. In a statement, the companies announced that they are "on track" to begin a vaccine safety and efficacy trial later this month to submit for government review from the federal Food and Drug Administration as early as October. The vaccine is among five in development with US support.
The $1.95 billion agreement with the HHS and Department of Defence – part of the Trump administration's "Operation Warp Speed" – promises free distribution of the vaccine to Americans, with up to 1.3 billion doses delivered by the end of 2021. It is the largest agreement yet between the government and drug firms as the world speeds towards development of a coronavirus vaccine.
The US can acquire up to 500 million doses, per the agreement.
"Expanding Operation Warp Speed's diverse portfolio by adding a vaccine from Pfizer and BioNTech increases the odds that we will have a safe, effective vaccine as soon as the end of this year," Secretary Azar said in a statement. "Depending on success in clinical trials, [the] agreement will enable the delivery of approximately 100 million doses of this vaccine to the American people."
During his first White House coronavirus press briefing since April, the president told reporters on Tuesday that "vaccines are coming, and they're coming a lot sooner than anyone thought".
"We now have five vaccine candidates that prioritise the US people," Secretary Azar told Fox News on Wednesday. "We're going to manufacture a vaccine and work to secure FDA approval of them all at the same time."
BNT162 is the companies' current vaccine candidate. Researchers said an early clinical trial discovered that the candidate produced some neutralising antibodies, which may be able to prevent future infections.
If the ongoing studies from Pfizer and BioNTech are successful, the companies will seek an Emergency Use Authorisation from the federal government, or regulatory approval for widespread use, as early as October.
In an interview with CNBC on Wednesday, Secretary Azar said that the government is "not concerned" about supply chain shortfalls that may hinder the vaccine's delivery.
"We've secured that to be able to ensure that we'll be able to vaccinate the American people once we get vaccines that are demonstrated safe and effective to the FDA's gold standard of approval or authorization," he said.
Pfizer and British-Swedish drug firm AstraZeneca – developing a vaccine with Oxford University – published a report in medical journal The Lancet this week claiming positive immune responses from early trials. That vaccine development is bolstered by more than $1 billion from the US government.
Moderna, a biotech firm that manufactured the first potential vaccine to be tested in humans, also recently claimed its drug showed a positive immune response in The New England Journal of Medicine. Moderna's vaccine development is supported by $486 million from the federal government.
The US government also has pledged more than $450 million to Johnson & Johnson and another $628 million to Emergent Biosolutions to expand vaccine and drug-manufacturing capacity
Roughly two dozen potential vaccines are currently being developed and tested around the world.
Nearly 4 million people in the US have been confirmed to be infected with Covid-19 since the onset of the outbreak. More than 142,000 people have died, according to Johns Hopkins University.
On Tuesday, the Centres for Disease Control and Prevention reported that the nation's actual rate of infection is likely 10 times higher than initially reported.
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