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TGA monitoring overseas Moderna recommendations


Matt Woodley


7/10/2021 6:18:09 PM

Several countries have limited the use of the mRNA vaccine in younger people, but there is no sign Australia will institute a similar pause.

Moderna vials.
Health agencies in Sweden and Denmark have limited the use of Moderna in younger people. (Image: AAP)

Decisions made by a small number of overseas regulators to limit the use of Moderna in a variety of younger cohorts have been noted by the Therapeutic Goods Administration (TGA) in its most recent COVID-19 vaccine weekly safety report.
 
Australia’s health regulator has said it continues to ‘closely monitor’ the small risk of myocarditis and pericarditis posed by the Moderna and Pfizer vaccines and is working with international medicines regulators to share emerging safety information.
 
Sweden and Denmark have temporarily paused the use of Moderna in people aged under 31 and 18 years respectively, based on an ongoing study being carried out by Danish, Norwegian and Finnish public health agencies.
 
However, the complete findings are not expected for another month and the European Medicines Agency approval of Moderna for people aged 12 and older remains.
 
Likewise, the Canadian province of Ontario has also issued a recommendation that people aged 24 and under receive the Pfizer vaccine preferentially over Moderna, but the Canadian National Advisory Committee on Immunization ‘continues to recommend vaccination with either mRNA vaccine for people 12 years and over’.
 
As of 3 October, Australia had recorded 218 reports of suspected myocarditis alone or in combination with pericarditis from approximately 16.6 million doses of Pfizer and 167,000 doses of Moderna.
 
In addition, the TGA has received 629 reports of suspected pericarditis alone related to the Pfizer vaccine and three reports of suspected pericarditis alone with Moderna.
 
‘The risk of myocarditis with both Moderna and Pfizer remains very low,’ the TGA stated.
 
‘It will be important to determine whether the difference in the frequency of reporting between the two mRNA vaccines of suspected myocarditis and pericarditis adverse events in some countries is due to greater awareness, or if it reflects an elevated risk.
 
‘There was much greater awareness of the association of the mRNA vaccines with myocarditis and pericarditis by the time the Moderna vaccine became widely used because its regulatory approval and rollout was some months after the Pfizer approval and rollout in most countries.’
 
Last week, the TGA released estimated domestic rates of myocarditis in relation to Pfizer, which confirm the condition is more likely to occur after the second dose.
 
In Australia, the condition is estimated to be occurring at a rate of:

  • 0.7 cases per 100,000 first doses
  • 1 case per 100,000 second doses
  • 1.4 cases per 100,000 first doses in recipients aged 12–19
  • 4.7 cases per 100,000 second doses in recipients aged 12–19.
Meanwhile, a further three cases of thrombosis with thrombocytopaenia syndrome (TTS) linked to the AstraZeneca vaccine have been recorded, bringing the total to 151 (84 confirmed, 67 probable).
 
Two of the new cases were in people aged under 60 years, and 12 people remain in hospital.
 
However, a person who last week was described as ‘critically unwell’ has since been discharged from intensive care, meaning there are currently no TTS cases in Australian ICUs.
 
Conversely, 303 people with COVID were listed as being in intensive care at the time of publication on 7 October.
 
Approximately 28.8 million vaccine doses had been given in Australia up to 3 October; 17 million first doses and 11.8 million second doses.
 
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AstraZeneca Moderna myocarditis pericarditis Pfizer TGA TTS vaccine safety report


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Dr Peter James Strickland   8/10/2021 12:27:32 PM

There appears to be a rare association in young people between mRNA vaccines against Covid 19 with myocarditis and pericarditis, but what is the incidence of heart problems with Covid 19 infection itself? I strongly suspect that there is a very much higher incidence of myocarditis/pericarditis in these unvaccinated Covid young patients that present with respiratory symptoms and signs as we see in others with compromised heart problems causing CCF lung oedema. Where are the statistics on heart problems occurring in Covid -infected unvaccinated patients?