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Pfizer Inc and its partner BioNTech Se plan to provide volunteers who received a placebo in its COVID-19 vaccine trial an option to receive a first dose of the vaccine by March 1, 2021, while staying within the study.
The trial’s Vaccine Transition Option permits all participants aged 16 or older the choice to discover whether they were given the placebo,”and for participants who understand they received the placebo, to have the option for the investigational vaccine whilst staying in the analysis,” the firms said on their website for trial participants.
The US Food and Drug Administration and a panel of its outside advisers have expressed concerns over Pfizer’s”unblinding” program, saying it might make it harder to keep on collecting data on effectiveness and safety required to acquire full FDA approval of the vaccine.
Trial participants who received the placebo will have two doses of the investigational vaccine reserved for them within the study, the firms said on the site.
