Very few adverse reports for children’s vaccination

The latest safety report published by the Therapeutic Goods Administration (TGA) presents a reassuring safety profile of COVID-19 vaccination for 5–11-year-olds.
 
The TGA’s weekly safety report states it had received around 240 adverse event reports from approximately 657,000 Pfizer doses administered in this age group up until 23 January.  
 
The rollout of the vaccination program for children aged 5–11 began on 10 January, with paediatric doses of Pfizer currently the only vaccine approved for the age group.
 
The most common reactions are reported as fainting, chest pain, nausea, vomiting and headache.
 
There were also four reports received of suspected myocarditis or pericarditis in the age group. However, on further review the TGA said none were likely to be either condition.
 
There have also been fewer adverse reactions reported to the Aus Vax Safety survey compared to other age groups.
 
At the time of publication, there had been 21,070 surveys completed for the site, which is led by the National Centre for Immunisation Research and Surveillance (NCIRS).
 
Of those, 29% reported an adverse reaction with the most common being local reaction such as pain, redness, swelling and itching. Fatigue was the next most common.
 
The evidence suggests vaccination for young children in Australia is following a similar pattern to the United States, which opened its vaccination program to younger children in November.
 
The TGA safety report says serious effects after vaccination in children in the US were ‘extremely rare’ with 100 confirmed from 8.7 million vaccine doses. Of these, 11 were confirmed reports of myocarditis, all of which were mild.
 
The TGA report also outlines a small number of myocarditis and pericarditis from the booster program, with close monitoring to continue as more young people come forward for a third dose.
 
The findings of a Vaccine Safety Investigation Group meeting last week (21 January) were also summarised. It concluded there was not enough evidence to link the deaths of two people with suspected thrombosis and thrombocytopenia syndrome (TTS) to the AstraZeneca vaccine.
 
No evidence of menstrual problem link
In the previous week’s safety report, the TGA stated it had recently carried out research into menstrual problems suspected to be related to COVID-19 vaccination
 
It concluded there is no evidence to link vaccines with menstrual issues. 
 
‘After assessing the reporting of menstrual problems in Australia and examining evidence from overseas regulators and the medical literature, the TGA’s review found that menstrual problems are very common generally and there is limited evidence that they increase after vaccination,’ the report reads.

While acknowledging two studies – one from the UK and another from Norway – which reported menstrual disturbances after vaccination, the TGA noted the findings had not yet been peer reviewed and were based on survey results.
 
The agency said it also considered studies from overseas regulators such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, MedSafe in New Zealand and the European Medicines Agency. None of them found evidence to suggest a link between COVID-19 vaccination and menstrual disorders, the TGA states.
 
It also said there is no evidence to suggest COVID-19 vaccines have an impact on fertility.
 
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