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Pharma & Biotech

US agency asks AstraZeneca to review COVID-19 vaccine trial results

It is understood that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data

AstraZeneca PLC’s (LON:AZN) trial results on the Coronavirus (COVID-19) vaccine developed with Oxford University have been questioned by a US agency.

The National Institute of Allergy and Infectious Diseases (NIAID) said on Tuesday that the pharma company should review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.

READ: Boris Johnson to lobby EU leaders to halt AstraZeneca vaccine export ban

The agency said that the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA and AstraZeneca that it was concerned by information released by AstraZeneca on Monday.

The DSMB said AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.

The FTSE 100 firm said the jab showed 100% efficacy against severe or critical disease and hospitalisation in trials on 32,449 participants, 141 of which developed symptoms of COVID-19.

The inoculation was also 79% effective at preventing symptoms, with comparable results across ethnicity and age and 80% efficacy in participants aged 65 years and over.

The company added that the DSMB identified no safety concerns related to the vaccine after conducting 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 characterised 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.

Shares dipped 1% to 7,272p on Tuesday morning.