US slaps down AstraZeneca over COVID-19 vaccine trial data

The US National Institutes of Health has issued an extraordinary slapdown of AstraZeneca, accusing the firm of misrepresenting data in the clinical trial of its COVID-19 vaccine.

A nurse prepares the COVID-19 AstraZeneca vaccine. Picture: Getty Images

The US government’s primary body for medical research, the National Institutes of Health, has issued an extraordinary slapdown of AstraZeneca, accusing the pharmaceutical giant of misrepresenting data in the US clinical trial of its COVID-19 vaccine.

The NIH said its Data and Safety Monitoring Board was “concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial”.

“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the NIH said. “We urge the company 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.”

The US President’s chief scientific adviser, Anthony Fauci, is the director of the NIH, which includes 27 institutes and centres and is a component of the US Department of Health and Human Services.

The NIH did not say which aspect of efficacy data AstraZeneca had misrepresented. The company reported on Monday an overall efficacy rate of 79 per cent for its vaccine based on the US clinical trial which involved 32,000 patients. That efficacy rate was higher than the 70 per cent efficacy recorded in previous clinical trials.

AstraZeneca also claimed in a news release announcing the results of the US clinical trial that its vaccine had “100 per cent efficacy against severe or critical disease and hospitalisation”, and “80 per cent efficacy in participants aged 65 years and over”.

The NIH’s statement will be damaging to AstraZeneca, which is seeking approval from the US Food and Drug Administration for its vaccine and which has been plagued by negative coverage over reports of serious blood clotting disorders in a very small number of people.

The AstraZeneca shot has also attracted controversy in Australia, with some doctors claiming it was inferior to the Pfizer vaccine.

It is not the first time AstraZeneca has been under fire over the conduct of its clinical trials. When it announced results of its initial clinical trial conducted in the UK and Brazil, it revealed that some participants had been accidentally given only a half-dose vaccine, which resulted in a higher efficacy rate.

If the FDA approves the AstraZeneca vaccine, by the time the approval comes through, the US will have ample vaccines from Moderna, Pfizer and Johnson & Johnson.