NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) and BioNTech SE (BNTX) said that the high vaccine efficacy observed through up to six months following a second dose in an updated analysis of COVID-19 vaccine phase 3 study.
Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrated that the companies' COVID-19 vaccine, BNT162b2, was highly effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to six months after the second dose.
The vaccine was 100% effective against severe disease as defined by the U.S. Centers for Disease Control and Prevention (CDC), and 95.3% effective against severe COVID-19 as defined by the U.S. Food and Drug Administration (FDA).
The companies noted that the vaccine was 100% effective in preventing COVID-19 cases in South Africa, where the B.1.351 lineage is prevalent.
According to the companies, no serious safety concerns were observed in trial participants up to six months after the second dose. Side effects were generally consistent with previously reported results.
Vaccine safety has now been evaluated in more than 44,000 participants aged 16 years and older with more than 12,000 vaccinated participants having at least six months of follow-up after their second dose.
The companies plan to share the results with worldwide regulatory agencies soon.
Copyright RTT News/dpa-AFX
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