Thursday, July 15, 2021

AstraZeneca vaccine: Australia’s drug regulator dismisses questions raised in US about outdated data


Australia’s drug regulator, the Therapeutic Goods Administration, has dismissed questions raised about “outdated information” in AstraZeneca vaccine data by the US Data and Safety Monitoring Board.

On Monday AstraZeneca released interim results from its phase 3 Covid-19 vaccine clinical trials which showed 100% efficacy against severe or critical disease and hospitalisation. It showed 80% efficacy in those aged 65 years and over and, overall, had 79% efficacy at preventing symptomatic Covid-19. These results were based on 32,449 participants.

But the independent Data and Safety Monitoring Board issued a statement saying it was concerned AstraZeneca may have included outdated information from that trial,. The US National Institutes of Health has urged AstraZeneca to work with the board to review the data and make the most accurate, up-to-date information public as quickly as possible.

Australia is relying on locally manufactured AstraZeneca doses for the bulk of its vaccine rollout. The TGA head, Prof John Skerritt, said the regulator was confident the complete data would be supplied next month in line with contractual arrangements.

“We will get the data warts and all,” Skerritt told the ABC on Wednesday. “I would say what was released was encouraging.”

A professor of epidemiology at La Trobe University in Melbourne, Hassan Vally, said such queries were not unusual but the global attention on Covid-19 changed things.

“This to me seems like a technical issue,” Vally said, adding: “This minor issue would normally occur in private, and any sort of clarification would normally occur outside of the public arena.”

While the transparency was welcome, he said, it was also “a little bit unfortunate”.

“It has the potential to undermine confidence in the AstraZeneca vaccine,” he said. “We want to try and avoid these situations when they occur, but at the same time acknowledge that this is another manifestation of how transparent the processes are, and how rigorous.

“The real-world evidence about how the vaccine is performing is absolutely fantastic and it’s clearly a safe and effective vaccine and everyone should have complete confidence in it.”

AstraZenecasaid the numbers were based on a pre-specified interim analysis with a data cut-off of 17 February. It had reviewed subsequent data and found they were consistent.

The director of infectious diseases at Mater Health Services, Assoc Prof Paul Griffin, said: “This to me does not signal cause for concern with the vaccine or the science supporting its use.

“Perhaps, though, there is an opportunity to improve the communication of some of this information and resolve issues such as this directly rather than letting it play out in the press.

“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.”

Answering questions at Senate estimates on Wednesday, Skerritt said it was unclear whether questions raised about the vaccine had led to increased vaccine hesitancy in Australia.



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