PFE Pfizer Inc

By Jared S. Hopkins and Chris Wack 

The U.S. has agreed to pay Pfizer Inc. and BioNTech SE nearly $2 billion to secure 100 million doses of their experimental Covid-19 vaccine to provide to Americans free of charge, the latest sign the government is readying plans to make vaccines available if proved to work safely.

Under the $1.95 billion agreement, the U.S. Department of Health and Human Services and the Defense Department will receive 100 million doses of the vaccine should it be cleared by regulators, and can also acquire an additional 500 million doses. The vaccine, which has shown promising preliminary results in small groups of patients, is set to enter late-stage testing this month.

No Covid-19 vaccine in development has proven to work safely yet, although dozens are being studied. The U.S. and other governments are spending billions of dollars to secure potential Covid-19 vaccines and treatments should they prove safe and effective. The race has countries scrambling as they try to secure enough vaccines and the supplies to transport them.

As part of its Operation Warp Speed program, the U.S. has already struck agreements with other vaccine developers to secure doses, including a $1.2 billion deal with AstraZeneca PLC for at least 300 million doses of a vaccine developed by University of Oxford researchers. A $1.6 billion agreement with Novavax Inc. will fund clinical studies of its experimental vaccine and establish large-scale manufacturing of doses.

The agreement with Pfizer and BioNTech is the largest from the U.S. so far to secure Covid-19 vaccine supplies. It won't fund any research and development, according to the companies, unlike other deals that helped pay for testing and the scale-up of manufacturing capacity.

"We're bringing all the resources to bear that we possibly can to try and be a part of a solution to what is a global pandemic," Pfizer Chief Business Officer John Young said in an interview. "The world is going to need a lot of vaccines."

Researchers expect final-stage studies of the most advanced experimental Covid-19 shots, including those from AstraZeneca, Moderna Inc. and Pfizer, will enter late-stage testing in the U.S. in the coming weeks with the possibility of being available later this year.

The rapid timetable opens the door for health regulators to permit use as early as the fall, if the shots prove to work safely in their phase 3 trials. The U.S. Food and Drug Administration has the authority to quickly authorize drugs and vaccines on an emergency basis. In May, the agency did so for the antiviral remdesivir from Gilead Sciences Inc. for hospitalized Covid-19 patients days after positive results.

How any potential Covid-19 vaccine is distributed in the U.S. remains to be worked out. Public-health experts suspect they will go initially to frontline health-care workers and responders, and possibly to essential workers like grocery, pharmacy, food-supply and mass-transit employees.

One possibility for distributing the vaccine is through the apparatus used to provide seasonal flu vaccines to children, public-health experts and analysts say.

The U.S. piggybacked on the children's vaccination program to send shots for the H1N1 virus to hospitals and doctors' offices during the avian-flu pandemic in 2009, said Phyllis Arthur, vice president for infectious diseases and diagnostics policy at the Biotechnology Innovation Organization trade group. The program could provide the basis for distributing a coronavirus vaccine, but it might need to be adjusted to ensure the vaccine reaches high-risk populations, including ethnic or racial minorities, Ms. Arthur added.

Pfizer plans to spend at least $1 billion on its Covid-19 vaccine program this year, Mr. Young said. To simplify delivery of its vaccines, Pfizer is making the shots at three U.S. plans, while relying on separate ones overseas for Europe, he said.

While the vaccines might be provided to Americans free of charge, New York-based Pfizer and Germany's BioNTech didn't specify pricing details. Analysts estimated the vaccine's price at $19.50 per dose, or $39 for two doses, based on the announcement. The price is in line with what the private sector pays for flu shots.

"These are extraordinary times, and our pricing will reflect that. And during the term of the pandemic we'll price our potential vaccine consistent with what we recognize as an urgent global health emergency," Mr. Young said.

The Pfizer and BioNTech vaccine is set to enter a late-stage, 30,000-person study this month. If the testing is successful and the vaccine is proven to work safely, Pfizer and BioNTech said they expect to seek emergency use authorization or some form of regulatory approval as early as October.

Earlier this week, the two companies released additional positive early-stage results of a trial in Germany, which supported results from a corresponding U.S. trial. The companies are studying at least four vaccine candidates.

The companies expect to manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021, subject to final dose selection from their clinical trial.

The Pfizer-BioNTech vaccine uses an innovative gene-based technology known as messenger RNA. Messenger RNA, or mRNA, carries instructions from DNA to the body's cells to make certain proteins. An mRNA vaccine has never been approved to prevent any infectious disease.

Aside from AstraZeneca and Novavax, other companies getting U.S. funding for coronavirus drug and vaccine programs are Moderna Inc., Johnson & Johnson and Regeneron Pharmaceuticals Inc.

Vaccines typically take years to develop and prove they work safely, and many fail during the process. For Covid-19, manufacturers and researchers have said advances in vaccine technology, aided by government and private investments, have helped shorten the development timeline.

Covid-19 vaccine developers are also combining phases of studies and studying their vaccines at the same time they are ramping up manufacturing capabilities, industry and health officials say.

"This is unprecedented, and that is the only way you can really move at this kind of speed -- is to do so many stages over your development and manufacturing process in parallel, rather than doing them sequentially," Mr. Young said.

Write to Jared S. Hopkins at jared.hopkins@wsj.com

(END) Dow Jones Newswires

July 22, 2020 15:45 ET (19:45 GMT)

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