Coronavirus: TGA doesn’t share US concerns over AstraZeneca interim data

Head of Australia’s medicines regulator dismisses US slapdown over AstraZeneca’s use of interim data in trial.

Workers at CSL roll out onto a truck the first batch of the AstraZeneca produced by CSL in Australia on Wednesday. Picture: Luis Ascui/Getty Images

The head of Australia’s medicines regulator has dismissed US government concerns over AstraZeneca’s use of interim data in a major American clinical trial, saying the company would supply complete data to Australia after the trial is over.

The US National Institutes of Health issued an extraordinary slapdown of AstraZeneca on Tuesday, accusing the pharmaceutical giant of using outdated data to justify a claimed efficacy rate of 79 per cent for its COVID-19 vaccine.

That rate was above the efficacy rate recorded in previous clinical trials in the UK and Brazil.

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“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the NIH said.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

In response to the US concerns, AstraZeneca issued a statement saying it would “immediately engage” with the data committee and update its analysis.

Professor Skerritt said the TGA does not share the concerns of US officials.

“We’re not particularly worried because by law we have to get the complete, unredacted set of data,” Professor Skerritt said.

“In fact, it’s a contractual requirement when we approve a product. That will come sometime during April. This was interim data that was released.”

AstraZeneca has promised to “immediately engage” with the NIH to address concerns over the misrepresentation of data, with the vaccine claimed efficacy rate in the US trial of 79 per cent now under question.

“The numbers published were based on a pre-specified interim analysis with a data cut-off of 17 February,” the company said.

“We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. We are now completing the validation of the statistical analysis.

“We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data. We intend to issue results of the primary analysis within 48 hours.”

The US stoush over the AstraZeneca vaccine came as Australia begins to distribute some of the 832,000 locally produced doses of vaccine manufactured by CSL.

The first batches of local vaccine were approved for release by the TGA after batch testing. Health minister Greg Hunt said there would be a total of 3.3 million doses of local vaccine being made available within the next three weeks.

Half a million vaccines a week will soon be distributed now to GP practices and state vaccination hubs. More than 29,000 doses of vaccine were administered by general practitioners within the first two days of Phase 1B this week.

Australia has also received another 159,000 doses of Pfizer vaccine which will be distributed to state vaccination hubs.