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WASHINGTON (Reuters) – Pfizer Inc and partner BioNTech plan to give volunteers who received a placebo in its COVID-19 vaccine trial the option of receiving a first dose of the vaccine by March 1, 2021, while remaining in study.
The trial’s vaccine transition option allows all participants 16 years of age or older to find out if they have received the placebo, “and participants who find out that they have received the placebo, to have the opportunity. to receive the experimental vaccine while remaining in the study ”. companies have declared on their website for trial participants.
The United States Food and Drug Administration and a group of its external advisers have expressed concern over Pfizer’s “blindfold” plan, saying it could make it more difficult to collect safety data and the efficacy needed to achieve full FDA approval of the vaccine.
Trial participants who received the placebo will be reserved two doses of the investigational vaccine as part of the study, the companies said on the website.
“The study doctor will follow the latest guidelines from the US Centers for Disease Control and Prevention and their local health authorities to provide the vaccine transition option to participants on a priority basis,” the companies said.
(Reporting by Aakriti Bhalla in Bengaluru; Editing by Daniel Wallis)
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