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ATAGI publishes new guidance on Pfizer

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With myocarditis and pericarditis having been linked to Pfizer in small numbers of patients in studies and real-world situations, people with a history of cardiac conditions may ask questions about receiving the vaccine.
 
The Australian Technical Advisory Group on Immunisation (ATAGI) has now published guidance on receiving mRNA COVID vaccines.
 
According to ATAGI, people with a history of any of the following conditions can receive an mRNA vaccine – eg Pfizer – but should consult a GP or cardiologist about the best timing and
whether any additional precautions are recommended:

• Recent (ie within the past six months) or current inflammatory cardiac illness, eg myocarditis, pericarditis or endocarditis
• Acute rheumatic fever
• Acute rheumatic heart disease
• Dilated cardiomyopathy (for people aged 12–29)
• Complex or severe congenital heart disease, including single-ventricle (Fontan) circulation
• Acute decompensated heart failure
• Cardiac transplant recipients

The advisory board is clear, however, that most pre-existing cardiac conditions are not regarded as contraindications to vaccination, and Pfizer is a recommended vaccine for people with a history of heart conditions.
 
‘This includes myocarditis, pericarditis or endocarditis [more than] six months prior to vaccination, coronary artery disease, myocardial infarction, stable heart failure, arrhythmias, rheumatic fever, prior history of rheumatic heart disease, Kawasaki Disease, most congenital heart disease and people with implantable cardiac devices,’ ATAGI stated in its guidance.
 
The guidance, which ATAGI developed with the Cardiac Society of Australia and New Zealand (CSANZ), underscores the fact the benefits of the vaccine are far greater than the risks.
 
‘ATAGI and CSANZ emphasise that the overwhelming benefits of vaccination in protecting against COVID-19 greatly outweigh the rare risk of these conditions,’ ATAGI stated.
 
‘And Comirnaty – Pfizer mRNA vaccine – continues to be recommended for all people ≥ 16 years of age who do not have any contraindications to the vaccine, in those aged 12–15 with specific medical conditions that increase their risk of severe illness from COVID-19, and in Aboriginal and Torres Strait Islanders aged 12–15.
 
‘People who develop myocarditis or pericarditis attributed to their first dose of [Pfizer] are advised to defer further doses of an mRNA COVID-19 vaccine and to discuss this with their treating doctor.’
 
The new guidance comes as the Federal Government on Monday announced that the Therapeutic Goods Administration (TGA) has provisionally approved another mRNA vaccine, Moderna, for use in Australia.
 
‘We will have 10 million of the Moderna doses arriving before the end of this year,’ Prime Minister Scott Morrison told reporters in Canberra.
 
‘The first one million doses [are] on track to arrive next month and will go to pharmacies. Then we will have three million in October, three million in November and three million in December.
 
‘This is another important tool that we have in our battle against COVID.’
 
As with Australia’s other COVID vaccines, Pfizer and AstraZeneca, Moderna requires two doses, though they are administered four weeks apart.
 
TGA head Professor John Skerritt said while Moderna has initially been approved for use in adults, that could expand to children in coming weeks.
 
‘We made the decision in conjunction with the company to do the adults first because that enabled us to reach a decision earlier, which can then start the whole process of access to the vaccine in Australia earlier,’ he said.

Correction: This article previously stated that pre-existing conditions myocarditis, pericarditis or endocarditis experienced fewer than six months prior to vaccination are not regarded as contraindications to vaccination.
 
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COVID-19 mRNA Pfizer vaccine

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