Pfizer jab closer to approval for children, IDT to make new Monash vaccine

Australian children aged five to 11 years of age could receive Pfizer’s COVID-19 vaccine soon after the Therapeutic Goods Administration (TGA) granted a provisional determination to the company in relation to the jab.

The provisional determination does not mean the Pfizer jab is approved for children now, rather it opens up a pathway for the pharmaceutical giant to submit an application to the TGA to have the vaccine approved.

Pfizer still has to submit data to the TGA in order to receive approval, but the provisional determination will speed up the process.

“In making its decision to grant Pfizer a provisional determination for use in individuals five to 11 years, the TGA considered eligibility criteria, including factors such as the evidence of a plan to submit comprehensive clinical data in relation to use in this age group - and the seriousness of the current COVID-19 pandemic,” the TGA said.

Currently, everyone in Australia 12 years and older is eligible to book an appointment to receive a Pfizer jab.

IDT secures manufacturing agreement with Monash University for COVID vaccine

Australian pharmaceutical manufacturing company IDT (ASX: IDT) has entered into a deal with Monash University to produce a new COVID-19 vaccine as part of a clinical trial.

Trials of the proposed Monash Institute of Pharmaceutical Sciences’ (MIPS) vaccine, an mRNA jab, are funded by mRNA Victoria and the Commonwealth Government’s Medical Research Future Fund.

IDT says the initial clinical trial will commence in the fourth quarter of this calendar year.

The vaccine candidate has been developed by MIPS in conjunction with The Peter Doherty Institute for Infection and Immunity and is Australia’s first locally developed mRNA vaccine candidate to progress to the clinical trial stage.

If successful, IDT believes it will be the first-ever Australian manufactured mRNA finished product.

Monash University President and Vice-Chancellor Professor Margaret Gardner AC said Monash is home to Australia's largest network of RNA and mRNA researchers.

“We are building an RNA ecosystem that will lead to the rapid development of life-saving vaccines and therapeutic treatments for communities across the country,” Professor Gardner said.

“To enable Australia to avoid ongoing issues around vaccine supply chains from other countries, we need our own mRNA production connected to research and development, and late-stage clinical trials capability.

“This partnership agreement with IDT and the ongoing support from the Victorian and Commonwealth Governments is a significant step in Australia moving towards establishing unlimited capability."

IDT Australia CEO Dr David Sparling said he was thankful to the Australian and Victorian Governments for their assistance in preparing the company’s sterile manufacturing facility for production of mRNA vaccines.

“We are very appreciative of the Australian Government’s support in getting IDT’s sterile manufacturing facility ready to take on a project of this nature; and for allowing IDT to utilise the facility for this work,” Dr Sparling said.

“We are also very appreciative of the Victorian Government’s support for this project. Being Australia’s first locally developed mRNA COVID-19 vaccine, all of the team here at IDT are excited to be a part of the MIPS project.

“It is a great opportunity for IDT to develop and showcase our cGMP manufacturing capabilities in mRNA product manufacture.”

IDT shares are up by more than 4 per cent at $0.625 each at 11:20am AEDT.

Meanwhile, following media reports that bio-medical giant CSL (ASX: CSL) would cease producing the AstraZeneca COVID-19 vaccine by Christmas, the company has reaffirmed its commitment to its deal with the Federal Government to produce the jabs into 2022.

In a statement, CSL said it was committed to the manufacture of approximately 50 million doses of the vaccine.

“Already over 20 million doses have been produced to protect Australians and those in the Asia Pacific region, and it is expected that the remaining production will be completed early next year,” CSL said.

CSL shares are up 1.84 per cent at $299.45 each at 11:20am AEDT.

Updated at 11.20am AEDT on 14 October 2021.