WASHINGTON (Reuters) – Pfizer Inc and its partner BioNTech intend to offer volunteers who received a placebo in its COVID-19 vaccine study an option to receive a first dose of vaccine until March 1, 2021, while remaining within study.
The study vaccine transition option allows all participants 16 years of age or older to choose whether to receive placebo, “and for participants who find that they have received a placebo, to have the option to receive the investigational vaccine while remaining in the study ”. said the companies on their website for trial participants.
The US Food and Drug Administration and a group of external advisers have expressed concern about Pfizer’s “unorbitable” plan, saying it may be more difficult to continue collecting safety and efficacy data needed to get full approval of the vaccine. to the FDA.
Trial participants who received placebo will have two doses of the investigational vaccine reserved for the study, the companies said on their 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 give participants the option to transition the vaccine in a priority manner,” the companies said.
(Reporting by Aakriti Bhalla in Bengaluru; Editing by Daniel Wallis)