The FDA’s Dr. Susan Wollersheim ran through the FDA’s analysis of Pfizer’s data from its Phase 3 trial involving 44,000 volunteers. The FDA checks the company’s primary data and odes not rely on the company’s summaries of what it found.
With 170 Covid-19 cases in the group, “eight in the vaccine group, and 162 in the placebo group — giving a vaccine efficacy of 95% for the prevention of Covid-19 from seven days after dose two,” Wollersheim told Thursday’s FDA Vaccines and Related Biological Products Advisory Committee meeting.
Among subgroups — such as age, comorbidities and sex — results show that “the vaccine efficacy was consistently high across different subgroup analyses,” she said.
Wollersheim did note that were some limitations in the “adolescent age because of small numbers of cases and participants, as compared to the adult population.” Additionally, another exception was “participants identifying as multiracial.” There were too few Covid-19 cases among multiracial volunteers to interpret the data.
The committee will vote later Thursday on whether to recommend that the FDA issue emergency use authorization for the vaccine.