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Pfizer and BioNTech plan to offer COVID-19 vaccine to volunteers who got placebo

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eMediNexus    02 January 2021

Pfizer Inc and its partner BioNTech intend to give volunteers who were administered a placebo in its COVID-19 vaccine trial an option to receive a first dose of the vaccine by March 1 this year, while staying within the study.

The Vaccine Transition Option will allow all participants aged 16 years or above the choice to discover if they received the placebo. The participants who learn that they received the placebo will have the option to receive the vaccine while staying in the study. Meanwhile, the U.S. Food and Drug Administration and a panel of its outside advisers are concerned over Pfizer’s “unblinding” plan, as it could make it tougher to collect data on safety and effectiveness needed to receive full FDA approval of the vaccine… (Reuters, January 2, 2021)

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