ATAGI review of AstraZeneca COVID vaccines: What GPs need to know

Morgan Liotta

25/03/2021 4:06:39 PM

The latest advice suggests there is only a ‘tiny’ risk of blood clots in some patients, but does include contraindications for two rare conditions.

Close up of AstraZeneca vaccine vial
No safety concerns related to the AstraZeneca vaccine were identified in the latest phase 3 trial. (Image: AAP)

The Australian Technical Advisory Group on Immunisation (ATAGI) on safety of the Oxford University/AstraZeneca COVID-19 vaccine, ATAGI has issued further advice related to the suitability of the Oxford University/AstraZeneca vaccine for people with a history of clotting conditions.
The updated advice stems from reviews conducted by the Therapeutic Goods Administration (TGA), European Medicines Agency (EMA) and World Health Organization, which pored over data from millions of recipients following reports of blood clots in some European countries.
As of 16 March, the EMA had reported 18 cases of cerebral venous sinus thrombosis (CVST) from millions of vaccine recipients, leading several European countries to pause their rollout of Oxford University/AstraZeneca vaccines.
However, the subsequent reviews have concluded that the benefits of the vaccine continue to outweigh the potential risks.
‘There is no increase in the rates of general thromboembolic disorders after vaccination over expected rates, noting these conditions occur commonly in the absence of vaccination,’ ATAGI states.
However, as a precautionary measure, ATAGI has also outlined an additional two conditions for contraindication or postponement of the COVID-19 vaccine until further investigations are carried out.
The vaccine should be deferred for people with a history of CVST and/or people with a confirmed medical history of heparin-induced thrombocytopenia.
Associate Professor Charlotte Hespe, RACGP NSW&ACT Chair and Head of General Practice and Primary Care Research at the University of Notre Dame, told newsGP the ATAGI advice comes at a critical time for GPs involved in the vaccine rollout.
‘This is great, timely guidance to assist GPs in being able to discuss with our patients about what Australian experts are advising us to do based on all the evidence of risk at this point in time,’ she said.
‘The good news is that we know that there is no increased risk in the older-age groups who will mostly be 1b participants, with very few that might be “iffy”, and these are people who we can highlight.
‘We can also rest assured that the possible calculated risk remains incredibly small – tiny.’
The RACGP supports ATAGI’s position that the benefits of the COVID-19 vaccine far outweigh the potential risk of blood clots, helping to ease concerns from Australians eligible for phase 1b of the rollout. RACGP President Dr Karen Price has also continued to reassure patients that there is no proven link between the COVID-19 vaccine and blood clots.
Meanwhile, newly released phase 3 trial data suggests the vaccine has 76% efficacy against symptomatic COVID-19 and 100% efficacy against severe or critical disease and hospitalisation.
Contrary to previous reporting, the vaccine was also found to offer more protection for people aged 65 years and over, with the vaccine demonstrating 85% efficacy against symptomatic COVID-19 in this cohort. No safety concerns related to the vaccine were identified in the trial.
Despite the results, Associate Professor Hespe said GPs will need to continue leading the charge against vaccine hesitancy and fresh fears from the blood clot incidents in Europe.
‘All health decisions are made with a background risk as part of our decision making,’ she said.
‘In this case the risk is really, really small regarding clots, whereas the risk of being significantly unwell, death, or long-term symptoms from COVID is significantly higher.
‘We are just fortunate in Australia to not really feel this risk as we have managed to keep the infection out so effectively.’
She also said Australia’s vaccine rollout has benefitted from this, compared to other countries around the world.
‘We have excellent health experts who are able to assess the evidence as it comes to hand and we can trust that they will advise us if anything changes, or if we need to add in any different criterion regarding the conversation about risk,’ Associate Professor Hespe said.
‘This is why we are in such a fortunate positon of not needing to rush out the vaccines to save lives every day like they are doing in Europe, the UK and USA.’
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Dr Trina Gregory   26/03/2021 7:17:26 AM

However, for the time being, ATAGI recommends that vaccination with any COVID-19 vaccine should be deferred for people who have a history of the following rare conditions. This is until further information from ongoing investigations in Europe is available and is only a precautionary measure:

people with a confirmed medical history of CVST; and/or
people with a confirmed medical history of heparin induced thrombocytopenia (HIT). HIT is an immune-mediated complication of treatment with heparin that affects platelet function. A HIT-like mechanism is being investigated as a potential, but unconfirmed, pathway to CVST post COVID-19 vaccination.

Dr Marc Houghton Heyning   26/03/2021 8:31:56 AM

I am quite supportive of the vaccination roll out but I think we can afford to divert more of our local production to PNG as a more immediate threat to our country’s health

Dr Maraiyur Sundaresa Ramanathan   3/05/2021 12:10:25 PM

Hi, want some advice regards astra zenica vaccine for people just turned 51, as they are adviced to have Astra zenica, this particular patient of mine had Breast cancer and had been on radio, chemo tharapies and tamoxifen fo the last 7 years, she is 51 , is she sagfe to have astrazenica or pfizer