Australian Government's AstraZeneca COVID-19 vaccine health warning

 

Australian Prime Minister Scott Morrison, media release, 8 April 2021:

Earlier this evening the Australian Government received advice from the vaccine expert taskforce, the Australian Technical Advisory Group on Immunisation (ATAGI).

The detail of that advice is attached.

The Government accepts the advice from Australia’s medical experts and will move swiftly to ensure Australia’s vaccination program and advice to patients is adjusted accordingly.

The Australian Government places safety above all else, as it has done throughout the pandemic, and will continue to follow the medical advice in protecting Australians.

The ATAGI advice is clear that the AstraZeneca COVID-19 vaccine is highly effective in preventing severe disease caused by COVID-19.

The medical advice to the Government is that the risk of blood clotting side effects from the Astra Zeneca vaccine is four to six in one million people, in the first four to 20 days post the vaccine. This is a rare but serious side effect.

On that basis, the recommendation is that it is preferred that the Pfizer vaccine be provided to adults under the age of 50. The AstraZeneca vaccine should only be given as a first dose to adults under the age of 50 where the benefit clearly outweighs the risk for that individual.

AstraZeneca is recommended for those over the age of 50.

The vaccination program will continue, particularly for the most vulnerable Australians in Phase 1B including those over the age of 70 who are not impacted by this revised advice.

The longer term timeframe for the program is being reviewed following this medical advice.

The Department of Health will provide preliminary, updated advice to general practitioners and health professionals.

The ATAGI advice follows further international evidence including from the vaccinations in Europe and the United Kingdom. ATAGI had already provided updated guidance on 2 April.

The ATAGI advice has today been considered by the Australian Health Protection Principal Committee (AHPPC), which is the Medical Expert Panel led by the Chief Medical Officer, and also comprising all State and Territory Chief Health Officers.

The advice will be provided to National Cabinet tomorrow.

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The Australian Technical Advisory Group on Immunisation (ATAGI) advice on the AstraZeneca COVID-19 vaccine in response to new vaccine safety concerns, excerpts;

“Definitions

 Thrombosis with thrombocytopenia syndrome (TTS) is a rare and new syndrome which hasbeen reported after being given the AstraZeneca COVID-19 vaccine. It may be caused by this vaccine. The condition involves blood clots (occurring in body sites like the brain or abdomen) together with low platelet levels.

 Thrombosis is the formation of a blood clot, which prevents blood flowing normally through the body.

 Thrombocytopenia is a condition in which you have a low blood platelet count. Platelets (thrombocytes) are blood cells that help blood clot. Platelets stop bleeding by clumping and forming plugs in blood vessel injuries.”

“ The AstraZeneca vaccine appears likely to be causally-linked with a risk of this newly recognised thrombosis with thrombocytopenia syndrome.

 There is currently uncertainty in, and different reported rates of risk, for this adverse event.

 Studies have suggested it may occur in approximately 4 – 6 people in every one million people in the 4-20 days after the first dose of vaccine. However, higher rates have been reported in Germany and some Scandinavian countries.

 Some evidence suggests the risk of this condition occurring may be somewhat higher in people of a younger age, however a small number of cases have been reported in people of different ages (including older adults).

 While there have been more reports of TTS in women in some settings, this may be because more vaccine doses have been given to women. In one country the reported rate of TTS (number of cases adjusted for the number of men and women vaccinated) was similar in men and women.

 TTS can cause serious long term disability or death (with death occurring in approximately 25% of reported cases).

 So far no specific biological risk factors or pre-existing medical conditions have been found to modify (i.e. increase or decrease) the risk of TTS occurring after AstraZeneca vaccine.

 We do not yet know to what extent earlier recognition of this syndrome and improved treatments will improve patient outcomes. More cases can be expected to occur, albeit rarely.

 Comirnaty (the Pfizer COVID-19 vaccine) does not appear to carry a risk of TTS. [my yellow highlighting]

NOTE: On 13 July 2020 AstraZeneca shares were worth US$61.10. By 8 April 2021 share price has fallen to US$49.78.