Primary analysis of AstraZeneca COVID-19 vaccine candidate backs interim data, dismissing U.S. concerns

Moving quickly to tamp down concerns raised by the independent Data Safety Monitoring Board (DSMB) this week, AstraZeneca announced today that primary analysis of its AZD1222 COVID-19 vaccine’s phase three trial confirmed 76 percent efficacy against symptomatic cases.

“The primary analysis is consistent with our previously released interim analysis and confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 years and over,” Mene Pangalos, executive vice president of AstraZeneca’s BioPharmaceuticals R&D, said. “We look forward to filing our regulatory submission for Emergency Use Authorization in the US and preparing for the rollout of millions of doses across America.”

A pall was cast over the trial’s interim data release earlier this week when the DSMB wrote U.S. federal agencies with concerns that the data involved was outdated. The latest data has since been dispatched to the DSMB and will serve as AstraZeneca’s basis for application for Emergency Use Authorization from the U.S. Food and Drug Administration (FDA).

In addition to its overall efficacy, the vaccine candidate provided 100 percent efficacy against severe or critical disease and hospitalization, as well as 85 percent efficacy against symptomatic COVID-19 in those 65 years or older. Of 32,449 trial participants, 190 symptomatic cases of COVID-19 emerged — another 49 beyond the interim data. However, this may change further. AstraZeneca noted that 14 additional possible or probable cases of COVID-19 remain to be adjudicated from the trial.

The vaccine also proved well-tolerated, without any major side effects.