Sydney Lupkin
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The Food and Drug Administration is working on a playbook for how it could greenlight vaccine tweaks. Studies in hundreds of people, rather than tens of thousands, seem likely.
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The two companies producing COVID-19 vaccines for use in the United States will have to raise production to meet contractual goals of 100 million doses each by the end of March.
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The two companies making COVID-19 vaccines each promised to deliver 100 million doses to the federal government by the end of March. So far, they appear to be running behind.
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The COVID-19 vaccine rollout faces another bottleneck: Pfizer and Moderna may be unable to fulfill contractual promises to deliver 100 million doses a piece to the federal government by March 31.
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A federal manufacturing contract to increase COVID-19 vaccine production has an unusual clause that could move a company's employees and their families to the front of the vaccination line.
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Emergent BioSolutions is under contract with Operation Warp Speed to make COVID-19 vaccines, but the terms could allow employees and their families to get vaccinated ahead of schedule.
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The drugmakers will add an additional 100 million COVID-19 vaccine doses to the number that they are already supplying the government. They expect to deliver all the doses by July 31.
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Despite being founded a decade ago, Moderna has never had a product make it to market. And the company registered its first factory with the Food and Drug Administration just this week.
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A Pfizer board member says the government declined to buy more doses beyond the initial 100 million already agreed upon. Demand from other countries could complicate future purchases.
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The $1.95 billion Operation Warp Speed contract excludes government rights to inventions or production know-how developed in the manufacture of the COVID-19 vaccine.