Volunteers in the Pfizer/BioNTech COVID-19 vaccine trials who received a placebo will be able to get a first dose of the vaccine by March 1, according to reports Saturday.
The companies said that the trial’s Vaccine Transition Option means that all participants can find out if they were given the placebo. Participants who learn they received the placebo “have the option to receive the investigational vaccine while staying in the study,” according to a statement for trial participants.
US Food and Drug Administration officials and outside advisers have said, however, that Pfizer’s “unblinding” plan could make it more difficult to continue collecting data on safety and effectiveness necessary for full FDA approval of the vaccine.
Trial participants who received the placebo will have two doses of the investigational vaccine reserved for them within the study, the companies said.
“The study doctor will follow the latest guidance from the US Centers for Disease Control and Prevention and their local health authorities to offer the Vaccine Transition Option to participants in a prioritized manner,” the companies said, Reuters reported.
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January 03, 2021 at 12:15AM
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Pfizer, BioNTech to offer vaccine to volunteers who took placebo - New York Post
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