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COVID-19 Vaccine Developers Adjust Phase 3 Trial Protocols to Allow Authorized Vaccines | 2020-12-17

The Pharma Data

Currently, healthcare personnel and long-term care facility residents participating in their trial are the only ones who can opt to receive the vaccine.

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FDA Advisory Panel Says Yes to Pfizer’s COVID Vaccine

The Pharma Data

First in line are health care personnel and residents and staff of long-term care facilities, according to earlier recommendations released by the CDC panel. Doctors say this reflects India’s younger and leaner population.

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Biden Will Ask Americans to Wear Masks for 100 Days

The Pharma Data

The recommendation from the Advisory Committee on Immunization Practice (ACIP), if heeded, will steer the initial short supply of vaccines to about 21 million health care personnel and 3 million Americans working or living in long-term care facilities. An FDA advisory panel is set to meet on Dec.

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CDC Director Warns of Dire Winter Ahead for COVID Hospitalizations, Deaths

The Pharma Data

The recommendation from the Advisory Committee on Immunization Practice (ACIP), if heeded, will steer the initial short supply of vaccines to about 21 million health care personnel and 3 million Americans working or living in long-term care facilities. An FDA advisory panel is set to meet on Dec.

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Britain Approves Emergency Use of Pfizer’s COVID Vaccine

The Pharma Data

The recommendation from the Advisory Committee on Immunization Practice (ACIP), if heeded, will steer the initial short supply of vaccines to about 21 million health care personnel and 3 million Americans working or living in long-term care facilities.

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Lilly’s Neutralizing Antibody Bamlanivimab (LY-CoV555) Receives FDA Emergency Use Authorization for the Treatment of Recently Diagnosed COVID-19

The Pharma Data

“This emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients – adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic,” said David A. Ricks, Lilly’s chairman and CEO.

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New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

Lilly has received feedback from front-line nurses and doctors administering these infusions regarding the complexity and time requirements for preparation and administration. It remains under review by the FDA. A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing.