Federal Health Minister Greg Hunt has written to the managing director of Pfizer in Australia asking for data on the use of its vaccine in children.
Overnight the pharmaceutical company said its mRNA coronavirus vaccine works for children ages five to 11, marking a key step toward beginning vaccinations for kids.
Mr Hunt said he was “heartened” by the research results and asked Pfizer to submit an application to the Therapeutic Goods Administration.
Health Minister Greg Hunt has written to Pfizer – “I encourage and invite Pfizer “submit a parallel application to the TGA” for its covid-19 vaccine for ages 5-12. @9NewsAUS #auspol #COVID19 pic.twitter.com/3X2P7N8xUq
— Jonathan Kearsley (@jekearsley) September 21, 2021
Pfizer is currently seeking authorisation from the US Food and Drug Administration to administer the vaccine to those aged 5-11.
“I note the announcement that Pfizer International is now intending to apply for regulatory approval of Pfizer’s COVID-19 vaccine for children aged 5 to 12,” Mr Hunt wrote to Managing Director of Pfizer Australia and New Zealand, Anne Harris.
“I encourage and invite Pfizer to submit a parallel application to the TGA for Australian regulatory approval at the earliest possible time.”
Australian Government Chief Nursing and Midwifery Officer, Alison McMillan, explained how the application process works in a press conference this afternoon.
“Data collected by these companies from overseas trials is assessed and the TGA will assess that data based on international guidelines of this purpose,” Professor McMillan said.
“If any application is received for this age group, obviously then the TGA very quickly will go and assess this information and make a decision.
“I understand that the Minister For Health has written to the Managing Director of Pfizer Australia and New Zealand… and has welcomed an application for the use of this vaccine in those aged five to 11 in Australia.
“If that application is received, then the TGA will go ahead through its clinical assessment.”Internet Explorer Channel Network