US FDA erratic approach to placebo-controlled trials after issuing an emergency use authorization for a COVID-19 vaccine

Two contradictory statements, as vaccinating those who received placebo forces breaking the blind that could lead, in the worse scenario, to the early termination of the trial as it was started although it could continue as an open-label trial.2 Clinical trial sponsors raise ethical requirements On October 15, Pfizer submitted a letter to the FDA commenting on the information provided for the Vaccines and Related Biological Products Advisory Committee (VRBPAC), that was going to be held on October 22 [8]. In the USA, the first trials started in Summer 2020. Since it is expected that all Americans will have access to a COVID-19 vaccine no later than April 2021 [13], termination of these trials could happen no later than early Spring 2021, several months before any COVID-19 vaccine candidate trial could had even reached a 12-month follow-up period –the minimum time needed to assess whether the vaccine has or not an effect on the community transmission of SARS-CoV-2 [14].4 Expanded access as an alternative to EUA The FDA has managed this critical topic issuing erratic and contradictory statements. [...]it is a much more controlled way of administering the vaccine than under an EUA and will restrict its administration to a limited number of individuals. [...]following the slow and lengthy procedure of an expanded access tens of thousands of individuals belonging to very high-risk groups will have access to the vaccine, rather than the tens of millions of individuals of all population groups that will be vaccinated in a much shorter period of time under an EUA.