(Reuters) – Pfizer Inc and its partner BioNTech Se plan to give volunteers who received a placebo in the COVID-19 vaccine trial an option to receive a first dose of the vaccine by March 1, 2021, while they remain within the study.
The trial’s vaccine transition option allows all participants 16 years of age or older to discover if they have received the placebo, “and for participants learning that they have received the placebo, to have the option to receive the test vaccine while they remain in the study, “the companies put to the test on their website here for participants.
The U.S. Food and Drug Administration and a panel of its external advisers have expressed concern over Pfizer’s “unblinded” plan, saying it may be more difficult to proceed with data collection on the safety and efficacy needed to to obtain FDA approval.
Participants in the trial who received the placebo had two doses of the research vaccine reserved for them within the study, the companies said on the website.
“The study physician will follow the latest guidance from the U.S. Centers for Disease Control and Prevention and their local health authorities to provide the vaccine transition option to participants in a predetermined manner,” the companies said.
Reporting by Aakriti Bhalla in Bengaluru; Edited by Daniel Wallis