WASHINGTON (Reuters) – Pfizer Inc and its partner BioNTech Se plan to give volunteers who received a placebo in the COVID-19 vaccine trial the 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 aged 16 and over 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 staying in the study, “the companies put to the test on their website for participants.
The U.S. Food and Drug Administration and a panel of its external advisers expressed concern about Pfizer’s “unblinded” plan, saying it could make it more difficult to continue collecting data on the safety and effectiveness needed to obtain the FDA’s approval of the vaccine.
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 clues from the U.S. Centers for Disease Control and Prevention and their local health authorities to offer the vaccine transition option to participants in a predetermined manner,” the companies said.
(Reported by Aakriti Bhalla in Bengaluru; edited by Daniel Wallis)