TGA investigates as concerns emerge over vaccine’s efficacy in over-65s

The Therapeutic Goods Administration (TGA) is taking a closer look at the AstraZeneca/Oxford University vaccine after reports from Germany suggested the vaccine is not very effective for people aged over 65.

German daily papers Handelsblatt and Bild said in seperate reports that the vaccine had an efficacy of less than 10 per cent among older people. However, the British-Swedish pharmaceutical company AstraZeneca has since denied those claims saying they’re “completely incorrect”.

“Reports that the AstraZeneca/Oxford vaccine efficacy is as low as eight per cent in adults over 65 years are completely incorrect,” the company said in a statement late Monday, SBS reports. “In November, we published data in The Lancet demonstrating that older adults showed strong immune responses to the vaccine, with 100 per cent of older adults generating spike-specific antibodies after the second dose.”

Aussie experts have also weighed in on the matter, with Hassan Vally from La Trobe University saying the reports coming from German newspapers are false, explaining: “The reason we have a lower certainty in the estimate of vaccine efficacy for those over 65 years is simply that the numbers who received the vaccines in these trials were much smaller than for the younger age groups. Smaller numbers in a trial means that the confidence around your estimate of vaccine efficacy is lower due to statistical inference.”

The vaccine is one of four supported by the Federal Government, and Australia has secured 53.8 million doses. Once approved, it’s expected to be rolled out across the country in March.

Acting chief medical officer Michael Kidd has reassured Aussies that the TGA is looking “at all of the evidence being put forward” on how well the vaccine works in older people. “That includes the results of the clinical trials as well as all … other research that has been carried out,” Professor Kidd said, The Australian reports. “They’ll be making the assessment for the AstraZeneca vaccine as they did for the Pfizer vaccine.

“We’re told that there is further research being done in the elderly, and of course we have the real-world experience of vaccines being rolled out under emergency provisions in different countries around the world.”

This isn’t the first time the AstraZeneca/Oxford University vaccine has made headlines. Earlier this month, there were calls from scientists to pause the rollout of the vaccine, due to concerns it may not be effective enough to generate herd immunity. Professor Paul Kelly, Australia’s chief medical officer, was quick to shut down those claims, telling breakfast show program Sunrise at the time, “One thing is clear from those interim results, this vaccine is very effective against severe disease – just exactly the same as the Pfizer and Moderna data.”

And it comes after the TGA granted provisional approval to the Pfizer/BioNTech Covid-19 vaccine on Monday. The vaccine has been approved for people aged over 16 and will be administered in two doses, at least 21 days apart, with the first vaccines expected to be administered in late February.

At the time, Prime Minister Scott Morrison said the TGA’s approval was a step in the right direction. “I welcome the TGA’s approval of the Pfizer vaccine, with our own Australian experts finding it is safe, effective and of a high standard,” he said in a statement on Monday, news.com.au reports. “Australians should take confidence in the thorough and careful approach taken by our world-class safety regulator.

“Our priority has always been to keep Australians safe and protect lives and livelihoods. Today’s approval is another big step forward for our community, particularly in the protection of our most vulnerable people.”