US health officials say AstraZeneca may have included ‘outdated information’ in coronavirus vaccine trial

The official discussed the contents on the condition of anonymity given the sensitivity of the matter.

The letter goes on to say, “Decisions like this are what erode public trust in the scientific process.”

The US study was supposed to help settle lingering questions about the effectiveness of a vaccine that is being widely used in Europe and other parts of the world and is about to be considered for use in America, too.

Rebuilding confidence in its vaccine was what AstraZeneca had hoped to accomplish when it announced that a predominantly US study of 32,000 volunteers showed its vaccine was 79 per cent effective in preventing symptomatic COVID-19 disease.

The study also showed that no vaccinated volunteers had suffered severe illnesses or hospitalisations.

But shortly after midnight, the National Institutes of Health issued a statement saying the independent monitors that oversee the study had “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”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 urged the company to “ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.”

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Fauci says spat is example of system working

Outside experts were surprised and puzzled by the spat.

But they noted that ultimately the Food and Drug Administration would scrutinise all the data before deciding whether AstraZeneca’s vaccine could be rolled out in the US.

“It would seem that whatever this communication misstep is, at the end of the day the data will have to stand for itself,” said Jesse Goodman of Georgetown University, a former FDA vaccine chief.

The NIH’s Anthony Fauci told US broadcaster ABC’s Good Morning America that the incident “really is what you call an unforced error” and that he expects the discrepancy to be straightened out.

Dr Fauci also said the episode showed the US regulatory system was working: “The data and safety monitoring board picking up this discrepancy was an example of a safeguard.”

Every vaccine trial is overseen by a “data and safety monitoring board”, or DSMB. These boards include scientists and statisticians who are experts in their fields but have no ties to either the government or the vaccine makers.

In the AstraZeneca study, just like studies of the other vaccines in use, some participants get the real vaccine and the rest get dummy shots, and neither they nor their doctors know which is which. Only the DSMB has the power to unlock the code of who got which and peek at how the volunteers are faring before a study is finished.

The DSMB watches for safety concerns and also deems when the study has met pre-determined endpoints showing it’s time for an effectiveness calculation.

It was the NIH-appointed DSMB that raised the concerns about AstraZeneca’s data.

On Tuesday local time, AstraZeneca said that the data it first released included COVID-19 cases that occurred up to February 17, as the study rules specified, and that it was continuing to analyse cases that had occurred since then.

It said a preliminary analysis of more recent data was consistent with what it had already reported.

It is common for companies developing COVID-19 vaccines to release early data and to continue studying results as they come in.