(Reuters) – Pfizer Inc and its partner BioNTech Se plan to give volunteers who received a placebo in their COVID-19 vaccine trial an option to receive a first dose of the vaccine by March 1, 2021, while within the continue research.
The study’s vaccine transition option gives all participants 16 years of age or older the choice to discover whether they received the placebo, “and for participants who learn they received the placebo, to have the option of receiving the study vaccine while they stay in the study, ”the companies said on their website here for trial participants.
The U.S. Food and Drug Administration and a panel of outside advisers have raised concerns about Pfizer’s “disintegration plan” and say it could become more difficult to continue to collect the safety and effectiveness data needed to complete the full FDA. get vaccine approval.
Trial participants who received the placebo will have two doses of the study vaccine reserved for them within the study, the companies said on the website.
“The study physician will follow the latest guidelines from the US Centers for Disease Control and Prevention and their local health authorities to provide the Vaccine Transition Option to participants in a prioritized manner,” the companies said.
Reporting by Aakriti Bhalla in Bengaluru; Editing by Daniel Wallis