(Reuters) – Pfizer Inc and its partner BioNTech intend to give 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 in the 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 here for the participants in the trial.
The US Food and Drug Administration and a group of external advisers have expressed concern about Pfizer’s “blinding” 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 US Centers for Disease Control and Prevention and their local health authorities to give participants the option to transition the vaccine as a matter of priority,” the companies said.
Reporting by Aakriti Bhalla in Bengaluru; Edited by Daniel Wallis