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AstraZeneca calls for reform after claims Australian rules stopped it defending its vaccine during pandemic AstraZeneca claims Australian rules stopped it defending its vaccine during pandemic
(32 minutes later)
Medical company says TGA regulations prevented it from responding to incorrect claims about its vaccine in 2021 Company says TGA regulations prevented it from responding to incorrect claims about its vaccine in 2021
AstraZeneca has called for reforms to Australia’s rules around discussion of medicines, saying public confusion over its Covid vaccine was created because the company was restricted in explaining health warnings by the nation’s medicines regulator.AstraZeneca has called for reforms to Australia’s rules around discussion of medicines, saying public confusion over its Covid vaccine was created because the company was restricted in explaining health warnings by the nation’s medicines regulator.
The call is contained in more than 2,000 submissions to the federal government’s inquiry into Australia’s handling of the coronavirus pandemic.The call is contained in more than 2,000 submissions to the federal government’s inquiry into Australia’s handling of the coronavirus pandemic.
State governments in NSW, Western Australia and South Australia have also been critical of the federal response to the pandemic, raising concerns about the former Coalition government’s decision-making, access to crucial data and poor coordination across jurisdictions. State governments in New South Wales, Western Australia and South Australia have also been critical of the federal response to the pandemic, raising concerns about the former Coalition government’s decision-making, access to crucial data and poor coordination across jurisdictions.
The inquiry, launched in September 2023 with a year-long reporting deadline, is examining the national response and interactions with other levels of governments and industry.The inquiry, launched in September 2023 with a year-long reporting deadline, is examining the national response and interactions with other levels of governments and industry.
One of the major disruptions to the nation’s response in 2021 was the Australian Technical Advisory Group on Immunisation (Atagi) ruling that, due to “rare but serious” blood clots, the AstraZeneca vaccine should not be the preferred Covid jab for people under 50.One of the major disruptions to the nation’s response in 2021 was the Australian Technical Advisory Group on Immunisation (Atagi) ruling that, due to “rare but serious” blood clots, the AstraZeneca vaccine should not be the preferred Covid jab for people under 50.
That vaccine, manufactured domestically, was envisaged as Australia’s vaccine rollout “workhorse”, with most people expected to receive that jab. But the April 2021 announcement, which was met with widespread confusion, said Pfizer – which Australia only had in short supply at the time – should be given to under-50s.That vaccine, manufactured domestically, was envisaged as Australia’s vaccine rollout “workhorse”, with most people expected to receive that jab. But the April 2021 announcement, which was met with widespread confusion, said Pfizer – which Australia only had in short supply at the time – should be given to under-50s.
Atagi said under-50s could receive AstraZeneca “where the benefits are likely to outweigh the risks” but the decision rocked public confidence.Atagi said under-50s could receive AstraZeneca “where the benefits are likely to outweigh the risks” but the decision rocked public confidence.
“The rollout of the Covid-19 vaccine AstraZeneca was impacted by public misperception relating to the risks associated with the vaccine. In preventing pharmaceutical companies from promoting medicines, [Therapeutic Goods Administration] regulations inadvertently prevented AstraZeneca from proactively responding to incorrect claims associated with adverse events,” the company wrote in its submission.“The rollout of the Covid-19 vaccine AstraZeneca was impacted by public misperception relating to the risks associated with the vaccine. In preventing pharmaceutical companies from promoting medicines, [Therapeutic Goods Administration] regulations inadvertently prevented AstraZeneca from proactively responding to incorrect claims associated with adverse events,” the company wrote in its submission.
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“The nuances in Atagi’s advice were quickly lost amongst the media and public commentators, with many interpreting the advice to say that there was a prohibition on the use of the AstraZeneca vaccine for persons under 50, and then under 60, rather than a recommendation.”“The nuances in Atagi’s advice were quickly lost amongst the media and public commentators, with many interpreting the advice to say that there was a prohibition on the use of the AstraZeneca vaccine for persons under 50, and then under 60, rather than a recommendation.”
AstraZeneca claimed nuances were “not well understood” by politicians or media, leading to “vaccine hesitancy”.AstraZeneca claimed nuances were “not well understood” by politicians or media, leading to “vaccine hesitancy”.
Atagi’s submission said it relied on the “best available and emerging data” in a “rapidly evolving Covid-19 landscape”. It said its normal communication pathways were “not fit for purpose” as it needed to communicate quickly.Atagi’s submission said it relied on the “best available and emerging data” in a “rapidly evolving Covid-19 landscape”. It said its normal communication pathways were “not fit for purpose” as it needed to communicate quickly.
While Covid-era leaders like Mark McGowan, Gladys Berejiklian and Dan Andrews do not appear to have made public submissions, several states claimed the federal government responded well, but lacked in some areas. While Covid-era leaders such as Mark McGowan, Gladys Berejiklian and Daniel Andrews do not appear to have made public submissions, several states claimed the federal government responded well, but lacked in some areas.
The SA government spoke of “tension” and “blurred responsibilities” in the division of state and federal roles, which “exacerbated challenges with the federation architecture”. Its submission said in future emergencies, the federal government should rethink how it distributes money to the states.The SA government spoke of “tension” and “blurred responsibilities” in the division of state and federal roles, which “exacerbated challenges with the federation architecture”. Its submission said in future emergencies, the federal government should rethink how it distributes money to the states.
A submission from the NSW government’s cabinet office said the federal government should oversee hotel quarantine. It was largely managed by states during Covid and was a major expense and political headache as the source of several virus outbreaks.A submission from the NSW government’s cabinet office said the federal government should oversee hotel quarantine. It was largely managed by states during Covid and was a major expense and political headache as the source of several virus outbreaks.
The NSW submission said the new federal Centre for Disease Control should manage “centralised approaches” to future pandemics, with calls for nationally consistent rules and messaging on quarantine and lockdowns. NSW also complained of vaccine schemes being “not well defined” after supples were procured by federal authorities but largely delivered by states.The NSW submission said the new federal Centre for Disease Control should manage “centralised approaches” to future pandemics, with calls for nationally consistent rules and messaging on quarantine and lockdowns. NSW also complained of vaccine schemes being “not well defined” after supples were procured by federal authorities but largely delivered by states.
“This led to challenges in rapid implementation, public confusion and delay. The rollout could have better leveraged states’ and territories’ established strengths in supply chains and logistical expertise,” NSW said.“This led to challenges in rapid implementation, public confusion and delay. The rollout could have better leveraged states’ and territories’ established strengths in supply chains and logistical expertise,” NSW said.
“Other healthcare professionals, such as nurses in GP practice, were not appropriately funded to increase the sustainability of vaccination capacity.”“Other healthcare professionals, such as nurses in GP practice, were not appropriately funded to increase the sustainability of vaccination capacity.”
WA’s premier, Roger Cook – the health minister during the pandemic - wrote a submission in his own name which also criticised federal responses, claiming the state’s “access to key data was constrained by commonwealth policy”. WA’s premier, Roger Cook, who was health minister during the pandemic, wrote a submission in his own name which also criticised federal responses, claiming the state’s “access to key data was constrained by commonwealth policy”.
His submission also called for changes to national cabinet, which was formed by Morrison during the pandemic and continued under Labor. Cook believes there is scope “to strengthen the processes, transparency and accountability” of the meetings, including earlier distribution of papers and “greater adherence to agreed processes”.His submission also called for changes to national cabinet, which was formed by Morrison during the pandemic and continued under Labor. Cook believes there is scope “to strengthen the processes, transparency and accountability” of the meetings, including earlier distribution of papers and “greater adherence to agreed processes”.
“This would help promote greater collaboration and less commonwealth-centric decision making, not just during times of emergency such as Covid-19, but over the longer-term as national cabinet shifts its focus to areas of strategic reform.”“This would help promote greater collaboration and less commonwealth-centric decision making, not just during times of emergency such as Covid-19, but over the longer-term as national cabinet shifts its focus to areas of strategic reform.”