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Pfizer Inc and its partner BioNTech plan to give volunteers who received a placebo in their Covid-19 vaccine trial an option to receive a first dose of the vaccine before March 1, 2021, while they remain in the study.
The trial vaccine transition option allows all participants 16 years of age or older the option to find out if they were given the placebo, “and participants who learn they received the placebo have the option of receiving the vaccine in research while they remain in the study. ” the companies said on their website https://www.covidvaccinestudy.com/participants for the trial participants.
The US Food and Drug Administration and a panel of its external advisers have raised concerns about Pfizer’s “unmasking” plan, saying it could make it difficult to collect the safety and efficacy data required to gain approval. total of the vaccine by the FDA.
Trial participants who received the placebo will have two doses of the investigational vaccine reserved for them within the study, the companies said on the website.
“The study physician will follow the latest guidelines from the US Centers for Disease Control and Prevention and their local health authorities to offer the vaccine transition option to participants on a prioritized basis,” said the Business.
Posted in Dawn, Jan 3, 2021
