(Reuters) – Pfizer Inc. and its partner BioNTech are scheduled to give volunteers who received a placebo in their COVID-19 vaccine trial the option to receive a first dose of vaccine before March 1. 2021, while remaining within the study.
The transition option of the trial vaccine allows all participants 16 years of age or older to find out if they were given the placebo, “and for participants who learn they received the placebo, to have the option to receive the research vaccine while they remain in the study. ” said the companies on their website here for test participants.
The U.S. Food and Drug Administration and a group of its external advisers have expressed concern about Pfizer’s “unfinished” plan, saying it could make it difficult to continue collecting safety and efficacy data needed to get full approval. FDA for the vaccine.
Participants in the trial who received the placebo will have two doses of the research vaccine reserved within the study, the companies reported on the website.
“The study physician will follow the latest guidelines from U.S. Centers for Disease Control and Prevention and their local health authorities to offer the option of vaccine transition to participants in a prioritized manner,” the companies said. .
Aakriti Bhalla reports in Bengaluru; Edited by Daniel Wallis