Australia’s drug regulator, the Therapeutic Goods Administration, has rejected the questions raised “Outdated information” in AstraZeneca vaccine data by the US Data and Security Monitoring Agency.
On Monday AstraZeneca released preliminary results from a Phase 3 Covid-19 vaccine clinical trial showing 100% efficacy against severe or critical illness and hospitalizations. It shows 80% efficacy in those aged 65 years and over and, overall, had a 79% efficacy in preventing Covid-19 symptoms. These results were based on 32,449 participants.
But the independent Data and Security Monitoring Agency issued a statement saying it was concerned AstraZeneca might include outdated information from the trial. US National Institute Health has urged AstraZeneca to work with the board to review the data and make the most accurate and up-to-date information public as quickly as possible.
Australia relies on locally produced doses of AstraZeneca for most of its vaccine launches. The head of TGA, Prof. John Skerritt, said the regulator was confident that the complete data would be provided next month in line with the contract arrangement.
“We’ll get the warts and all,” Skerritt told the ABC on Wednesday. “I think what’s released is very encouraging.”
Hassan Vally, a professor of epidemiology at La Trobe University in Melbourne, said such questions were not uncommon, but that global attention to Covid-19 was changing things.
“It seems to me like a technical problem,” said Vally, adding: “These small problems usually occur privately, and any kind of clarification usually takes place outside the public arena.”
While transparency is welcome, he said, it is also “a little unfortunate”.
“This has the potential to undermine confidence in the AstraZeneca vaccine,” he said. “We want to try and avoid this situation when it occurs, but at the same time admit that this is another manifestation of how transparent the process is, and how rigorous it is.
“The real world evidence of how vaccines work is absolutely fantastic and this is definitely a safe and effective vaccine and everyone should have full confidence in it.”
AstraZenecasaid’s figures are based on a pre-determined preliminary analysis with a data limit on 17 February. It has reviewed subsequent data and found that they are consistent.
Director of infectious diseases at Mater Health Services, Assoc Prof Paul Griffin, said: “To me this does not signal a concern about vaccines or the science that supports their use.
“However, there may be opportunities to improve the communication of some of this information and resolve issues like these head-on rather than letting them play in the press.
“What is clear is that regulatory approval is not based on press releases and that the data available so far has been, and future data will continue to be available, fully available to regulators for review. Therefore, problems like this should not diminish our confidence in this vaccine or its use in our country or any other country. “
Answering a question on the Senate forecast on Wednesday, Skerritt said it was unclear whether the questions raised about vaccines had led to increasing vaccine doubts in Australia.