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News & Trends - Pharmaceuticals

AstraZeneca vaccine controversy a shame, says UQ Professor

Health Industry Hub | March 26, 2021 |

Pharma News: The US National Institute of Allergy and Infectious Diseases (NIAID) released a statement suggesting AstraZeneca may have included outdated information in the trial of its COVID-19 vaccine, which may have provided an incomplete view of the efficacy data.

At the time AstraZeneca responded to the NIAID statement saying that the initial numbers published were based on a pre-specified interim analysis with a data cut-off of 17 February. Following the completion of the validation of the statistical analysis the updated results were almost identical.

Paul Griffin, Director of Infectious Diseases at Mater Health Services, Associate Professor of Medicine at the University of Queensland, and Medical Director and Principal Investigator at Q-Pharm, Nucleus Network said “It is such a shame that a vaccine with so much evidence supporting its safety as well as efficacy continues to be shrouded in controversy. We heard very positive news almost a week ago that the EMA’s safety committee concluded that the vaccine was not associated with an increase in the overall risk of blood clots and therefore the benefits of receiving the vaccine continue to outweigh the risk of side effects.

“This was followed just two days ago by the press release of what certainly appears to be promising results from the interim analysis of the US phase 3 trial that reported 79% efficacy, comparable efficacy across ethnicity and age, and a favourable reactogenicity and overall safety profile.

A/Prof Griffin continued “It is important to note that this trial used a shorter dosing interval and it appears data support a higher efficacy with a longer interval as is the plan in Australia. Given these results have only been reported in the format of a press release we do need to interpret them in this context and await the formal reporting of these results in a peer-reviewed publication.

“Unfortunately, after appearing to have all of the perceived issues addressed, the NIH statement yesterday has once again fuelled some scepticism with relation to this vaccine. This was based on some reported concern by the DSMB that outdated information may have been included thus providing an incomplete view of the efficacy. To me, this seems like a highly atypical approach to resolving an issue such as this and is very unfortunate in terms of the perception of this vaccine.

“What is clear is that regulatory approvals are not based on press releases and that the data available thus far has, and future data will continue to be, made available in full to regulators for review. Issues such as this therefore should not detract from our confidence with this vaccine nor its use in our or other countries.

“As the only COVID-19 vaccine currently able to be manufactured in Australia, and the exciting news that the first four batches have been approved for release, we need to continue to support its use in an evidence-based manner with faith in our regulator the TGA, and not falsely sound the alarm over coincident events with no established link or based on perceived issues with how results are communicated in the press,” he concluded.


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