The Therapeutic Goods Association (TGA) approved the Oxford/AstraZeneca vaccine for use in Australia on Tuesday, but it may not be such good news for older Australians.
As YourLifeChoices reported last month, there has been only limited testing of the vaccine on over 65s and, while the TGA has approved the vaccine for use in all Australians aged 18 years or older, it recommended that use in over 65s be approved on a case-by-case basis.
The TGA statement on the approval of the vaccine explained that patients over 65 had demonstrated a strong immune response in clinical trials, but there was an “insufficient number of participants infected by COVID-19 to conclusively determine the efficacy in this subgroup”.
“The decision to immunise an elderly patient should be decided on a case-by-case basis with consideration of age, co-morbidities and their environment, taking into account the benefits of vaccination and potential risks,” the TGA statement says.
At the press conference to announce the approval for the AstraZeneca vaccine, TGA boss Professor John Skerritt said that didn’t mean there was an upper age limit for the vaccine, explaining, however, that more data was needed on that age group.
“Our approval of this vaccine does not have an upper age limit,” Prof. Skerritt said. “The data for this vaccine in older groups is limited, and that goes back to the original design of the trials, where AstraZeneca targeted their initial trials towards healthcare workers, who are of working age and usually under 65, and only included older people later on.
“Our analysis of the data gives us no reason to suspect that the vaccine would not be fully efficacious in older groups.”
Prof. Skerritt also said that the results in the United Kingdom, where vaccinations with both the AstraZeneca vaccine and Pfizer vaccines had been going on for more than a month, had demonstrated extremely strong results in groups of older adults.
“There is real-world evidence of the vaccine going well in older groups, and there is also evidence from blood tests looking at the response of the immune system to these vaccines, that again shows a strong immune response in people over 60, people over 65, and so forth,” Prof. Skerritt said.
“More data on a lot of things will emerge as months and weeks and years go by, including the duration and how long the vaccines provide protection for.
“On the balance of the evidence, we have no reason, and we felt there was no reason, to limit its use to particular age groups.”
The TGA’s approval of the AstraZeneca vaccine is valid for two years and means that it can now be legally supplied in Australia.
The approval is subject to certain strict conditions, including a requirement for AstraZeneca to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials.
While the AstraZeneca vaccine has been proven to prevent COVID-19, it is not yet known whether it prevents transmission.
The initial supply of the AstraZeneca vaccine will be imported into Australia from overseas, but it is anticipated that ongoing supply will be manufactured in Australia, although further information must be submitted to the TGA to confirm that onshore manufacturing will meet strict quality standards.
Are you hopeful that you will be approved for the Pfizer vaccine instead of the AstraZeneca vaccine? Are you disappointed by how long it has taken for Australia’s vaccine rollout to start?
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