AstraZeneca COVID-19 vaccine achieves safety and efficacy results in US
pharmafile | March 22, 2021 | News story | Sales and Marketing |
Results from the US trial of AstraZeneca’s COVID-19 vaccine (AZD1222) show it is 79% effective at stopping symptomatic COVID-19 disease and 100% effective at preventing people from falling seriously ill, it was announced today.
More than 32,000 volunteers took part in the study which was run by experts at Columbia University and the University of Rochester in collaboration with AstraZeneca in the US, Chile, and Peru.
Approximately 20% of the trial’s participants were over 65, which should help plea the vaccine’s case among EU countries that initially would not authorise the use of the vaccine in adults over 65, citing lack of evidence.
Ann Falsey, Professor of Medicine at the University of Rochester School of Medicine and co-lead Principal Investigator for the trial, said: “These findings reconfirm previous results observed in AZD1222 trials across all adult populations but it’s exciting to see similar efficacy results in people over 65 for the first time. This analysis validates the AstraZeneca COVID-19 vaccine as a much-needed additional vaccination option, offering confidence that adults of all ages can benefit from protection against the virus.”
AstraZeneca’s independent data safety monitoring board (DSMB) found no safety concerns relating to the vaccine, and conducted a specific review of thrombotic events, as well as cerebral venous sinus thrombosis (CVST) with the assistance of an independent neurologist. The DSMB found no increased risk of thrombotic events and no occurrences of CVST in the trial.
The Phase III results announced today should clear a pathway towards FDA approval in the coming months. Mene Pangalos, Executive Vice President at BioPharmaceuticals R&D, said: “These results add to the growing body of evidence that shows this vaccine is well tolerated and highly effective against all severities of COVID-19 and across all age groups.
“We are confident this vaccine can play an important role in protecting millions of people worldwide against this lethal virus. We are preparing to submit these findings to the US FDA and for the rollout of millions of doses across America should the vaccine be granted US Emergency Use Authorization.”
Kat Jenkins
