The United States on on Tuesday signed a $1.95 billion agreement with US pharma giant Pfizer and Germany’s BioNTech for 100 million doses of their experimental COVID-19 vaccine, part of an aggressive push to start immunizing Americans early next year.
It is the biggest deal to date under Operation Warp Speed, intended to accelerate the development, manufacturing, and distribution of coronavirus vaccines, therapeutics, and diagnostics.
US deal for free vaccine roll out
Pfizer and BioNTech, which are developing the drug together, said in statements that the American people would receive the future vaccine “for free” in line with the Trump administration’s pledge.
Under the agreement, the US government has placed an initial order for 100 million doses to be delivered if regulatory approval is granted.
The US government also has an option to purchase as many as 500 million additional doses from the two firms.
BioNTech and Pfizer have narrowed their vaccine candidates down to two frontrunners and are waiting for the green light to begin a mass trial involving 30,000 healthy volunteers, which may happen later this month.
If the studies are successful, they expect to receive some form of emergency approval as early as October 2020.
Encouraging results from potential vaccine
Earlier this month, they announced that early results showed their lead candidate produced neutralizing antibodies in humans at or above the levels observed in recovered COVID-19 patients.
This was accomplished with relatively low doses and caused side effects that were mild to moderate but transient, which is considered normal.
“We are assembling a portfolio of vaccines to increase the odds that the American people will have at least one safe, effective vaccine as soon as the end of this year,” said health secretary Alex Azar of the deal.
“We are honored to be a part of this effort to provide Americans access to protection from this deadly virus,” added Albert Bourla, chairman and CEO of Pfizer.
Vaccine race among producers and US investment in all baskets
Labs around the world are racing to produce a vaccine to help end the worst health crisis in over a century.
More than 200 candidate vaccines are currently being developed with roughly two dozen at the stage of clinical trials with human volunteers.
These scientists are at the forefront of the hunt for a coronavirus vaccine, and the first human trials of their experimental candidate begin next week. Here's the story of their scramble to turn back a pandemic. https://t.co/h2jiCuB3KG
— NYT Science (@NYTScience) July 20, 2020
Earlier this month, the US signed a $1.6 billion deal with Novavax for 100 million doses.
In May, the government announced up to $1.2 billion for AstraZeneca’s candidate vaccine, developed in conjunction with the University of Oxford.
The US has also announced $456 million for Johnson & Johnson’s vaccine candidate; $486 million for Moderna’s; and $628 million for Emergent Biosolutions.
The government is likewise investing in manufacturing capacity at its own risk, and spending hundreds of millions in companies that produce syringes, vials and medical glass-coated plastic containers.
Vaccines from both firms rely on RNA messengers
The Pfizer-BioNTech vaccine method relies on using messenger RNA, genetic code from the SARS-CoV-2 that slips into human cells to produce a synthetic form of the virus’ spike protein.
This in turn causes the host to generate antibodies. The idea behind the technology is decades-old, but has never brought a vaccine to regulatory approval.
“We are encouraged by the clinical data of BNT162b1, one of four mRNA constructs we are evaluating clinically, and for which we have positive, preliminary, topline findings,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer.
“These preliminary data are encouraging in that they provide an initial signal that BNT162b1 targeting the RBD SARS-CoV-2 is able to produce neutralizing antibody responses in humans at or above the levels observed in convalescent sera – and that it does so at relatively low dose levels. We look forward to providing further data updates on BNT162b1,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
The ongoing U.S. Phase 1/2 randomized, placebo-controlled, observer-blinded study is evaluating the safety, tolerability, and immunogenicity of escalating dose levels of BNT162b1.
A BioNTech spokeswoman told that two injections would probably be needed for maximum protection, with the booster shot following seven days after the first injection.
Based on the price paid by the US government, it would therefore cost $39 to immunize a person against the deadly virus.
AFP with additional input by GVS News Desk