Approfondimenti - Riflessioni English Other languages Società

Does the FDA think these data justify the first full approval of a covid-19 vaccine?

23 Agosto 2021 by

… the paper is based on the same data cut-off date (13 March 2021) as the 1 April press release

… Whatever one thinks about the “95% effective” claims (my thoughts are here)

… this additional information was available to Pfizer in April, it was not published until the end of July

… for 77% of trial participants were from the United States, where Delta was not established until months after data cut-off

… By 13 March 2021 (data cut-off), 93% of trial participants (41,128 of 44,060; Fig 1) were unblinded

… <10% of trial participants who remained blinded at six months … could constitute a reliable or valid sample to produce further findings

… still ongoing, two year pivotal trial, with no reported data past 13 March 2021

… unclear efficacy after six months due to unblinding

… waning protection irrespective of the Delta variant

… limited reporting of safety data

… “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.”