Pfizer and BioNTech have reported that updated topline results from Phase III study of their Covid-19 vaccine, BNT162b2, demonstrated an efficacy of 91.3% against the disease, measured seven days through up to six months after the second dose.
The latest data is from an analysis of 927 confirmed symptomatic Covid-19 cases observed in the trial through 13 March.
The updated analysis was carried out in line with guidance from the US Food and Drug Administration (FDA) for all companies assessing Covid-19 vaccines to review safety and efficacy at key milestones.
Furthermore, the vaccine showed to be 100% effective against severe disease as defined by the US Centers for Disease Control and Prevention (CDC). It was 95.3% effective against severe Covid-19 as defined by the FDA.
Safety data from over 12,000 vaccinated subjects who were followed up for six months after the second dose, showed a favourable safety and tolerability profile of the vaccine.
Vaccine efficacy of 100% in preventing Covid-19 cases was observed in South Africa, where the B.1.351 lineage is rampant.
Pfizer chairman and CEO Albert Bourla said: “These data confirm the favourable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the US FDA.
“The high vaccine efficacy observed through up to six months following a second dose and against the variant prevalent in South Africa provides further confidence in our vaccine’s overall effectiveness.”
The company noted that consistent vaccine efficacy was observed across age, gender, race and ethnicity demographics, as well as across subjects with various underlying ailments.
Last week, Pfizer and BioNTech reported that a Phase III trial of BNT162b2 showed 100% efficacy and strong antibody responses in adolescents aged 12 to 15 years with or without prior evidence of SARS-CoV-2 infection.