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US orders $1.95 Billion Covid-19 Vaccine from Pfizer and BioNTech

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 all Americans free of charge. 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 U.S. has already made other agreements including a $1.2 billion deal with AstraZeneca PLC for at least 300 million doses of a vaccine developed by University of Oxford. How any potential Covid-19 vaccine is distributed in the U.S. remains to be worked out. Pfizer plans to spend at least $1 billion on its Covid-19 vaccine program this year.  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. Reegulatory approval as early as October. The Pfizer-BioNTech vaccine uses an innovative gene-based technology known as messenger RNA. Messenger RNA.
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.
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. Pfizer shares climbed 5.1%, leading the Dow Industrial Average to close 0.6% higher Wednesday on news of the government agreement, even as some state officials and hospital systems continued to grapple with surging coronavirus infections. 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.
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. 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. plants, 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. 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.
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 Pfizer and BioNTech other companies getting U.S. funding for coronavirus drug and vaccine programs are AstraZeneca, Novavax, 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. Source: Link: https://www.wsj.com/articles/pfizer-biontech-get-1-95-billion-covid-19-vaccine-order-from-u-s-government-11595418221 By Jared S. Hopkins, Reporter and Chris Wack, Copy Editor. Jared S. Hopkins at jared.hopkins@wsj.com Publisher: The Wall Street Journal Published July 22, 2020

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