Due to Pfizer’s approval to submit an application to the medical authorities, Australia is one step closer to providing Covid-19 vaccines for children aged six months to five years.
Pfizer has been awarded a preliminary determination by the Therapeutic Goods Administration, enabling the pharmaceutical behemoth to submit an application to expand vaccine usage to the younger generation.
The Pfizer vaccine is currently only allowed for use in those aged five and older, but since US regulators recently approved a similar move, there has been talk of expanding its use to younger children.
The tentative determination, according to a TGA representative, was the initial stage.
The severity of the COVID-19 pandemic and evidence of a strategy to submit thorough clinical data were two factors that the TGA took into account, he added.
“Approval and prospective supply in Australia would only start if the vaccine were found to be safe and efficacious by the TGA and advised for administration to this age group by ATAGI,” according to the statement.
The administration is already debating whether to approve the Moderna vaccination for kids under five.
Mark Butler, the minister of health, declined to provide a specific timeline for when the pediatric vaccine would be made available.
He told reporters in Canberra, “The TGA will take the time it needs to take, that’s always been our approach, that was the past government’s approach.”
I don’t mind how long it takes them to complete the task effectively.
In order to ensure that vaccinations were prepared for distribution once they were formally licensed, according to Mr. Butler, negotiations had been held with Moderna and Pfizer.
The health minister countered that it was still too early to estimate the take-up rate.
“This country has an excellent track record of up to five immunizations normally,” he said.
“We’ll be thinking about what help and information we provide to parents about this,” the statement reads. “What the take up by parents of under-five children will be is a bit unknown.”
The TGA stated that the decision merely permitted Pfizer to apply for extended usage and did not imply that Pfizer had already submitted an application or that it had been approved.
Australia is on track to report the 10,000th virus-related fatality within the next few days.
The current 24-hour reporting period saw 50 fatalities in NSW, Victoria, and Queensland combined, bringing the overall death toll to 9897.
Due to the emergence of novel sub-variants that make patients more susceptible to a second dosage, NSW Health is predicting an increase in cases this winter.
The predominant variety is still the BA.2 sub-lineage. However, BA.4 and BA.5 are anticipated to do so shortly and are most likely connected to an increase in infections.
In Queensland, vaccines are no longer required for visitors to hospitals, nursing homes, facilities for people with disabilities, and prisoners.
Workers in high-risk environments like early childhood, primary and secondary school, jails, youth detention facilities, and airports are likewise exempt—absent mandatory vaccination requirements from employers.