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TGA approves Moderna as adolescent booster
An ongoing study demonstrates that the booster produces a similar immune response in this cohort to adults aged 18–25, the regulator says.
The TGA said it carefully considered data from an ongoing clinical study before making its decision.
Patients aged 12–17 may soon have an additional COVID-19 vaccine booster choice, with the Therapeutic Goods Administration (TGA) approving Moderna’s Spikevax for this purpose.
The approval paves the way for the Australian Technical Advisory Group on Immunisation (ATAGI) to begin its own assessment as to the clinical appropriateness of the vaccine for this use.
However, while the TGA has said the vaccine is safe for use among all 12–17-year-olds, COVID booster vaccinations are currently only recommended for adolescents 16 years and older, or 12–15-year-olds who fall into one of the following groups:
- Those who are severely immunocompromised
- Those who have a disability with significant or complex health needs
- Those who have complex and/or multiple health conditions that increase the risk of severe COVID-19
In making its decision, the TGA said it ‘carefully considered’ data from an ongoing clinical study, as well as expert advice from the Advisory Committee on Vaccines, an independent committee with expertise in scientific, medical and clinical fields including consumer representation.
‘The booster phase of the study, which included over 1300 participants aged 12–17 years, demonstrated that the immune response to the booster was similar to that seen in young adults aged 18–25 years,’ the regulator stated.
‘The safety profile in individuals aged 12–17 years was similar to that seen in young adults with no new safety concerns.’
In addition to Moderna, eligible adolescents seeking a COVID booster can also receive Pfizer’s Comirnaty vaccine, which was provisionally approved for this purpose among 16–17-year-olds in
January, and 12–15-year-olds in
April.
According to its most recent COVID-19 vaccine safety report, the TGA has received about 4280 adverse reaction reports from approximately 3.7 million doses of Comirnaty and Spikevax in 12–17-year-olds (one in 864 doses). To date, the most commonly reported reactions have been chest pain, headache, dizziness, nausea and fever.
Meanwhile, approximately 14.2 million people have received boosters in Australia, including 4.9 million people who have received a fourth dose.
‘We have received approximately 9680 reports of suspected adverse events identified as occurring after a booster dose,’ the TGA report states.
‘Adverse event reports for booster doses include a small number of
myocarditis and pericarditis cases.
‘So far, reports of myocarditis after a booster dose are very rare, occurring in less than one in every 100,000 vaccinated people.’
Headache, swollen lymph nodes (also called lymphadenopathy), chest pain, muscle pain and fever are the most commonly reported adverse effects following boosters, the TGA says.
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