US watchdog questions AstraZeneca vaccine trial data

A US medicines agency has claimed UK-based pharmaceutical company AstraZeneca may have provided incomplete information from the clinical trials conducted for the Covid vaccine it developed alongside the University of Oxford.

The National Institute of Allergy and Infectious Diseases (NIAID) has questioned whether or not the UK-based company can seek certification in the US as planned. The news comes one day after clinical trials in the US found the vaccine was perfectly safe, and less than a week after the European Medicines Agency (EMA) reapproved the vaccine for use in Europe.

Read more: AstraZeneca US trials hint at jab's safety

The AstraZeneca vaccine saw temporary suspensions across the European Union after being linked with blood clots and a patient's death.

The data gathered suggested the risk of blood clots was no more prevalent than in the general population and the EMA urged member states to continue their vaccination efforts, admitting the pros far outweighed the cons.

13 countries in all suspended the vaccine, but countries such as France and Germany have resumed the inoculation process.

However, an opinion poll released on Monday shows many Europeans remain sceptical about its efficacy.

Trial data released yesterday show the vaccine had a 79% efficacy rate in preventing the disease and was 100% effective in stopping people falling critically ill due to Covid.

However, the NIAID said it had been notified by the trial's data and safety monitoring board (DSMB) that “it was concerned by information released by AstraZeneca on initial data from its Covid-19 vaccine clinical trial," it announced in a statement.

“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” it added.

Authorisation and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and the Centers for Disease Control and Prevention after a thorough review of the data by independent advisory committees, the NIAID added.

The AstraZeneca vaccine was a frontrunner in the fight against the coronavirus pandemic but had since been marred by a number of controversies, most notably its supply to the European Union.

Read more: Thai sniffer dogs can detect Covid-19 in sweat with 95% accuracy

However, the company has ramped up production in the face of new strains of the virus appearing.

It was first approved for rollout in the UK - the first major Covid vaccine to do so - on January 4.

The company also faced criticism for the way it disclosed the results of its phase 3 clinical trials.

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