Pfizer: Covid-19 vaccine meets all efficacy endpoints
(CercleFinance.com) - Pfizer said on Wednesday that its Covid-19 vaccine candidate met all its efficacy endpoints in a late-stage trial, with the drugmaker planning to submit this data "within days" to the FDA.
The US company and its German partner BioNTech said final analysis of their ongoing Phase 3 study showed a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection, the trial's first primary endpoint.
The experimental vaccine also showed an efficacy rate of 95% in participants with and without prior SARS-CoV-2 infection, the study's second primary endpoint.
Ths first primary analysis is based on 170 cases of Covid, of which 162 cases were observed in the placebo group versus eight cases in the vaccinated group.
As the safety milestone required by the US Food and Drug Administration for an emergency use authorization has been achieved, Pfizer and BioNTech said they plan to submit a request within days to the FDA for an emergency approval.
Copyright (c) 2020 CercleFinance.com. All rights reserved.
The US company and its German partner BioNTech said final analysis of their ongoing Phase 3 study showed a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection, the trial's first primary endpoint.
The experimental vaccine also showed an efficacy rate of 95% in participants with and without prior SARS-CoV-2 infection, the study's second primary endpoint.
Ths first primary analysis is based on 170 cases of Covid, of which 162 cases were observed in the placebo group versus eight cases in the vaccinated group.
As the safety milestone required by the US Food and Drug Administration for an emergency use authorization has been achieved, Pfizer and BioNTech said they plan to submit a request within days to the FDA for an emergency approval.
Copyright (c) 2020 CercleFinance.com. All rights reserved.