AusVaxSafety data show that COVID-19 vaccines are safe in over 200,000 Australian children

Australian children aged 5–15 years report fewer side effects in the days following mRNA COVID-19 vaccination than those reported in clinical trials and published safety data, new AusVaxSafety-led research has found. The rate of side effects reported was similar across sex and Indigenous status, but increased with age and was higher for children with parent-reported chronic medical conditions. The Australian Australian Technical Advisory Group on Immunisation (ATAGI) says side effect rates are below what has been observed internationally for this age group. No self-reported cases of myocarditis or pericarditis were reported in Australia.

New research led by AusVaxSafety found that Australian children ages 5 to 15 who got the mRNA COVID-19 vaccine had fewer side effects than those reported in clinical trials and published safety data.

Researchers looked at the answers to 392,268 surveys collected by AusVaxSafety’s national active vaccine safety surveillance system after people got the mRNA COVID-19 vaccine between July 2021 and May 2022.

25 percent of children ages 5–11 who took the first dose of Pfizer 10 micrograms and 28 percent of those who took the second dose had at least one side effect in the first three days.

In children ages 12–15, 32% of people who took the first dose of Pfizer 30 micrograms reported at least one side effect in the first 3 days, 49% after the second dose of Pfizer 30 micrograms, 34% after the first dose of Moderna 100 micrograms, and 64% after the second dose of Moderna 100 micrograms.

The most common side effects in both age groups were pain, itching, redness, and swelling at the injection site, fatigue, headaches, and pain in the muscles and joints. It is known that these side effects can happen after a vaccine. They are usually mild and short-lived, with most going away in a day or less.

The rate of side effects reported was the same for both sexes and Indigenous people, but it went up with age and was higher for kids whose parents said they had long-term health problems. Overall, the number of people who went to the doctor stayed low (0.3%), and the effect on daily life was also low (7 percent ).

Associate Professor Nick Wood, the study’s lead author and Associate Director of Clinical Services and Vaccine Safety at the National Centre for Immunisation Research and Surveillance (NCIRS), said, “Australian data analysed to date are very reassuring, and side effect rates in children aged 5–11 years are lower than what has been seen internationally for this age group.”

Associate Professor Nick Wood also stated that it is important to note that fever, which can cause febrile seizures in children under 6 years old, was low in the youngest age group and similar to what was seen after the annual flu shot.

“No self-reported cases of myocarditis or pericarditis were identified in this study and these data provide confidence to parents on the safety of mRNA COVID-19 vaccines used in Australia,” added Associate Professor Wood.

AusVaxSafety is still keeping a close eye on the safety of the COVID-19 vaccine in children, including the Moderna 30 micrograms COVID-19 vaccine for kids under 12 and the third doses. The AusVaxSafety website will get new information about how safe these groups are.

AusVaxSafety will start monitoring children ages 6 months to 5 years old as soon as vaccines are ready for use, pending recommendations from the Australian Technical Advisory Group on Immunisation (ATAGI).