Volunteers in the Pfizer / BioNTech COVID-19 vaccination trials who received a placebo will be able to receive a first dose of the vaccine, according to 1 Saturday.
The companies said the trial’s vaccine transition option means all participants can find out if they are getting the placebo. Participants who learned that they had received the placebo “had the option to receive the study vaccine while staying in the study,” according to a statement to trial participants.
However, U.S. Food and Drug Administration officials and external advisers said Pfizer’s “unblinded” plan could make it more difficult to proceed with data collection on the safety and efficacy required for the full approval of the vaccine by the US Food and Drug Administration. FDA.
Participants in the trial who received the placebo had two doses of the research vaccine reserved for them within the study, the companies said.
“The study physician will follow the latest guidance from the U.S. Centers for Disease Control and Prevention and their local health authorities to provide the vaccine transition option to participants in a predetermined manner,” Reuters reported.