Pfizer Inc and its partner BioNTech Se plan to give volunteers who received a placebo in its Covid-19 vaccine trial an option to get a first dose of the vaccine by March 1, 2021, while staying inside the study.
The trial’s Vaccine Transition Option allows all participants aged 16 or older the choice to discover if they were provided the placebo, “and for participants who memorize they received the placebo, to have the option to get the investigational vaccine while staying in the study,” the companies said on their website.
The United States Food and Drug Administration and a panel of its out of doors advisers have expressed concerns over Pfizer’s “unblinding” plan, saying it could make it harder to continue collecting data on safety and effectiveness needed to win full FDA approval of the vaccine.
Trial participants who received the placebo will have two doses of the investigational vaccine reserved for them inside the study, the companies said on the website.
“The study doctor will follow the newest guidance from the United States Centers for Disease Regulate and Prevention and their native health authorities to offer the Vaccine Transition Option to participants in a prioritized manner,” the companies said.[ad_2]