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

The Pharma Data

COVID-19 vaccine developers are faced with an ethical quandary — whether to let phase 3 trial participants become “unblinded” and to receive authorized vaccines as they become available, which could hinder the collection of meaningful trial data. Pfizer, which has received emergency approvals in the U.S.

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Biden Will Ask Americans to Wear Masks for 100 Days

The Pharma Data

Having beat the United States to emergency authorization may pressure American regulators, who are already taking heat for not moving faster to get doses to people, the Times reported. Around the world, researchers are testing 57 vaccines in clinical trials, and nearly 100 others are being tested in animals or cell, the Times reported.

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

The Pharma Data

Having beat the United States to emergency authorization may pressure American regulators, who are already taking heat for not moving faster to get doses to people, the Times reported. Around the world, researchers are testing 57 vaccines in clinical trials, and nearly 100 others are being tested in animals or cell, the Times reported.

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Britain Approves Emergency Use of Pfizer’s COVID Vaccine

The Pharma Data

Having beat the United States to emergency approval of a coronavirus vaccine may pressure American regulators, who are already taking heat for not moving faster to get doses to people, The New York Times reported. The global race to develop a vaccine has been stunningly fast. Hospitalizations reach record high.

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Study Suggests Link Between Sleep Supplement and COVID-19

The Pharma Data

A study published in the journal Cell Discovery back in March initially suggested that melatonin – and repurposing existing medicines in general – may be the key to regulating COVID-19 within the body. A study published as recently as November took a closer look at the theory.

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Lilly Announces Agreement with U.S. government to Supply 300,000 vials of Investigational Neutralizing Antibody Bamlanivimab (LY-CoV555) in an Effort to Fight COVID-19

The Pharma Data

Discussions with global regulators are ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing.

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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

We thank those who have contributed to this medical advancement, particularly the clinical trial investigators and participants around the country.” Lilly is in discussions with global regulators to make bamlanivimab available around the world. Across all treatment arms, the trial will enroll over 800 participants.