Sydney. Australian children aged 5-11 will begin receiving the Pfizer vaccine from 10 January. The vaccine has received final regulatory approval and is recommended for use in this age group by the Australian Technical Advisory Group on Immunization (ATAGI). The ATAGI recommends that children aged 5-11 years be given two 10 microgram doses (that’s one-third of the dose for children over the age of 12), spaced eight weeks apart.
What do trial data say about safety and efficacy? Pfizer’s vaccine trial involved 2,268 children aged 5-11 years. Of these children, 1,517 were given two doses of the 10 microgram vaccine at three-week intervals, and 751 were given a placebo. The results found that the vaccine was safe and had good efficacy. Children who took the vaccine had similar antibody levels to adolescents and adults (aged 16-25) after the second dose. This indicates that their immune system was able to recognize the low amount of the vaccine mRNA.
No serious reactions occurred in this trial, although the sample size was not large enough to detect rare adverse events. The most common side effects occurred in the first two to three days and included arm pain (about 70 percent at any time in the first week after vaccination but usually in the first few days), headache (about 25 percent) and fatigue ( about 35 percent). The vaccine was found to be nearly 90 percent effective in preventing infection, with three confirmed cases in the group and 16 cases in the placebo group. Based on this data, the Therapeutic Goods Administration (TGA) tentatively approved the vaccine for use in Australian children aged 5-11 years on Sunday, following United States Food and Drug Administration (FDA) approval in late October. approved by.
How safe and effective has it been in other countries? There are around 2.3 million children in Australia between the ages of 5-11 years. So, let’s look at the actual experience of the Pfizer vaccine in the US to see what we can expect. More than 5 million American children aged 5-11 have taken one dose and more than 2 million have taken a second dose. Meanwhile, officials are concerned about the potential for a heart problem called myocarditis as a side effect of the vaccine.
This is a rare side effect observed after the second dose in older children aged 12-17, with an estimated risk of approximately ten cases per 100,000. No cases of myocarditis, or the related condition pericarditis, were reported in a clinical trial of 5-11 year olds. There is no data yet available on the vaccine’s real-world effectiveness in preventing hospitalization or infection in children aged 5-11 years, although this will emerge. Why the eight week gap?
The United States, the European Union, Canada and Israel have approved Pfizer for young children. The US considers a three-week gap between doses as fine, while Canada recommends eight weeks. There are two reasons for the wide gap. The first is a potentially improved immune response. Studies in adults have shown a greater difference between doses in the form of higher antibody immune response and better vaccine effectiveness, although this has not yet been observed for children under 12 years of age. The second is a potentially low risk of developing myocarditis.
According to a Canadian study, 18-24-year-olds with an interval of more than eight weeks between the first and second doses had a lower rate of myocarditis than those with less than 30 days of difference between the two doses. Was. Similar data for children under 12 years of age are not yet available, but recommending a wider interval between the two doses will allow us to continue monitoring international experience regarding the risk of myocarditis. Who needs to be first in line to get the vaccine? Some children with underlying medical conditions are more likely to get sick with COVID. This includes children suffering from obesity, diabetes, neurological diseases, heart and lung problems.
These children should be among the first to receive the vaccine next January. If my child is about to turn 12, should I wait? There is no major difference in the immune system between the ages of 11 and 12. If your 11-year-old is about to turn 12, he should get the vaccine and not wait in this regard. If a child took the 10 microgram dose and they turned 12 years old before having the second dose, the ATAGI says they may get a second dose of 30 micrograms by age 12. How will the vaccine be administered?
The small (10 microgram) child’s dose is packaged in vials with orange lids so that it is not to be confused with the purple- or gray-lid (30 microgram) dosing vial used for adults. The vaccine will be given in the upper part of the child’s arm, and you and the child will need to wait at least 15 minutes after the vaccination to see a reaction. The vaccine will be available through generic means, through healthcare centers, community pharmacies, and state and regional clinics.
If your child is going to have another vaccine, the other vaccines may be given at the same time. But when both a covid and a non-covid vaccine are given at the same time, there is very limited data on what side effects they can cause. If your child has had a COVID-19 infection, they should still be vaccinated, but it is important to make sure they have fully recovered before getting vaccinated.