WASHINGTON (Reuters) – Pfizer Inc and its partner BioNTech are planning to give volunteers who received a placebo in their COVID-19 vaccine trial the option of receiving the first dose of the vaccine by March 1, 2021, while they remain in the study.
The study’s Vaccine Transition Option gives all participants aged 16 and over the choice to find out whether they have received the placebo, “and for participants who discover they have received the placebo, to have the option of receiving the experimental vaccine while remaining on the study”. the companies said on their website to the test participants.
The Food and Drug Administration and a panel of its external consultants have expressed concern about Pfizer’s “unbundling” plan, saying it could hinder the collection of safety and efficacy data needed to obtain full vaccine approval by the FDA.
Study participants who received the placebo will have two doses of the experimental vaccine reserved for them in the study, the companies said on the website.
“The study doctor will follow the latest guidelines from the U.S. Centers for Disease Control and Prevention and their local health officials to offer the Vaccine Transition Option to participants on a prioritized basis,” the companies said.
(Reporting by Aakriti Bhalla in Bengaluru; Editing by Daniel Wallis)