US Agency Concerned About AstraZeneca Trial Data

Close on the heels of AstraZeneca announcing results of the US phase III trial of AZD1222, US health agency said in a statement that the British drug major may have included outdated information in trial results of its COVID-19 vaccine.

This casts doubts on the announced vaccine efficacy rate of 78.9 percent at preventing symptomatic COVID-19 and 100 percent at preventing severe disease and hospitalization. In participants aged 65 years and over, vaccine efficacy was 79.9 percent.

On Monday, AstraZeneca had announced positive late-stage trial results of its covid-19 vaccine AZD1222 in the U.S. The company said the U.S. trial met the primary efficacy endpoint in preventing COVID-19 at interim analysis.

The 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.

As AstraZeneca prepares for the primary analysis to be submitted to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA), the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca late Monday that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial.

The U.S. National Institute of Allergy and Infectious Diseases (NIAID) said in a statement that, “the DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”

The NIAID has urged AstraZeneca to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible. AstraZeneca had earlier said the DSMB identified no safety concerns related to the vaccine.

This move by the NIAID could delay the planned submission of the primary analysis of the trial to the U.S. FDA to seek EUA for the vaccine in the U.S.

The vaccine has been granted a conditional marketing authorization or emergency use in more than 70 countries across six continents. It is also included in the Emergency Use Listing of the World Health Organization that gives access in up to 142 countries through the COVAX Facility.

This news comes at a time when several European countries decided last week to resume the AstraZeneca vaccinations after the European Medicines Agency concluded that the anti-COVID vaccine is safe and effective.

At least 13 European countries had either temporarily halted AstraZeneca vaccine AZD1222 inoculations or delayed its roll out as a precaution following reports of patients developing thrombosis or blood clots after receiving AstraZeneca vaccine jabs.

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