AstraZeneca says vaccine effective, will seek FDA emergency use
The AstraZeneca novel coronavirus (COVID-19) vaccine candidate, AZD1222, demonstrated 79 percent efficacy at preventing symptomatic COVID-19 and 100 percent efficacy at preventing severe disease and hospitalization, according to an announcement made by the company earlier today.
Interim safety and efficacy analysis was based on 32,449 participants accruing 141 symptomatic cases of COVID-19. The trial had a 2:1 randomization of vaccine to placebo, the company said. Vaccine efficacy was consistent across ethnicity and age. in participants aged 65 years and over, vaccine efficacy was 80 percent.
According to the study, the vaccine was well tolerated, and the independent data safety monitoring board (DSMB) identified no safety concerns related to the vaccine. The DSMB 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 thrombosis or events characterized by thrombosis among the 21,583 participants receiving at least one dose of the vaccine. The specific search for CVST found no events in this trial.
AstraZeneca representatives say they plan to apply for emergency use authorization from the U.S. Food and Drug Administration (FDA) in the first half of April. An FDA advisory committee will review the evidence before the agency decides whether to grant emergency use. If the FDA approves the vaccine, company representatives said it will deliver 30 million doses immediately and another 20 million within the first month.