(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 a 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 here for 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 make it more difficult to continue collecting the 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 US Centers for Disease Control and Prevention and their local health officials to offer the Vaccine Transition Option to participants on a prioritized basis,” said the companies.
Reporting by Aakriti Bhalla in Bengaluru; Edition of Daniel Wallis