Australia’s Therapeutic Goods Administration (TGA) has granted a provisional determination to Pfizer, allowing the pharmaceutical company to apply for approval to extend use of its COVID-19 vaccine to children aged 6 months to 4 years.
So what does this mean for families with under 5s?
As Director of the Wesfarmers Centre of Vaccines and Infectious Diseases, Professor Chris Blyth explains, the move doesn’t mean the vaccine is assured for this age group – but it is the first step in that direction.
“The TGA has confirmed that it will be willing to review data on the Pfizer COVID-19 vaccine designed for children 6 months to 4 years,” Professor Blyth said. “This follows the recent review of this vaccine in this age group by the US Food and Drug Administration.”
Is the vaccine the same for young children as for adults?
The dose approved by the FDA in this age group is a 10th of the adult dose, and three doses are given.
“Similar levels of COVID-19 immunity are generated with three doses in younger children compared with two doses in young adults,” Professor Blyth said. “This means the vaccine is likely as effective in young children as in adolescents and young adults. A very low rate of side effects have been observed in this age group in the clinical trials.”
What happens next?
Professor Blyth said the TGA move was the critical first step in the required process to provide COVID-19 vaccines to our youngest Australians.
“The TGA will independently assess the safety and efficacy of the vaccine and, if approved, clinical recommendations will be provided by the Australian Technical Advisory Group on Immunisation (ATAGI),” he said.
Although this is encouraging, there are still a number of steps required before we will have this vaccine for use in Australia – as it comes in a different preparation to the vaccine used in older children, approval will be required prior to supplies being provided by the manufacturer.
Aren’t COVID-19 cases dropping? Why should I bother getting my child vaccinated?
“It is likely that many parents will question what is the role of such a vaccine, particularly given many young children have already been infected,” Professor Blyth said.
“Despite this age group being a lower risk of severe COVID-19 compared with adolescents and adults, large numbers of preschool children are being infected, a number of which are sick enough to require hospitalisation. A small number of children are unwell enough to be admitted to intensive care, and although rare, COVID-19 related deaths have been reported in this age group.
These children are presenting with a range of illnesses including high fever, vomiting and diarrhoea, noising breathing (croup), breathlessness and cough. It is expected that many of these illnesses are preventable through vaccination.” Professor Blyth added that children with underlying medical conditions were at particular risk of severe COVID-19.
“So if the vaccine is approved by the TGA and recommended by ATAGI, there are many children who are likely to benefit for the vaccine, particularly those not previously infected or with underlying health conditions,” he said.
Similarly, infectious diseases clinician-researcher Associate Professor Asha Bowen, of The Kids Research Institute Australia and Perth Children’s Hospital, welcomed the decision to progress consideration of the vaccine for children aged 6 months to 4 years.
“This is good news for families with younger kids who have been concerned about them being unvaccinated for COVID-19,” she said. “We await the deliberations from TGA and ATAGI as to when and how this program might be established in Australia.”
For more information on the decision, see the TGA’s media release here.
- Chris Blyth is Director of the Wesfarmers Centre of Vaccines and Infectious Diseases, based at The Kids Research Institute Australia, Professor of Paediatrics with The University of Western Australia (UWA) School of Medicine, a paediatric infectious diseases physician at Perth Children's Hospital, and a Clinical Microbiologist with PathWest Laboratory.
- Asha Bowen is a clinician-researcher at Perth Children’s Hospital, Head of Skin Health at the Wesfarmers Centre of Vaccines and Infectious Diseases, based at The Kids Research Institute Australia, and a Clinical Associate Professor with the UWA Medical School, Paediatrics. She was recently appointed as the Institute's Program Head of Vaccines and Infectious Diseases.