TGA approves Pfizer/BioNTech vaccine

The Australian Therapeutic Goods Administration (TGA) has provisionally approved the Pfizer/BioNTech COVID-19 mRNA vaccine, COMIRNATY.

Following a thorough and independent review of Pfizer’s submission, the TGA has decided that this vaccine meets the high safety, efficacy and quality standards required for use in Australia. The provisional approval means that COMIRNATY is now included in the Australian Register of Therapeutic Goods (ARTG) for active immunisation to prevent coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2, in individuals 16 years of age and older.

Provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia. The approval is subject to certain strict conditions, such as the requirement for Pfizer to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and post-market assessment. COMIRNATY has been shown to prevent COVID-19; however, it is not yet known whether it prevents transmission or asymptomatic disease.

The distribution of the vaccine in Australia will be prioritised by the Department of Health according to the populations identified in guidance from the Australian Technical Advisory Group on Immunisation (ATAGI) COVID-19 Working Group.

“Today’s provisional approval in Australia marks an historic moment in the fight against COVID-19,” Pfizer Australia and New Zealand Managing Director Anne Harris said.

“It further affirms Pfizer’s commitment to deliver on its promise to safely bring to Australians a high-quality vaccine against this virus.

“We commend the TGA for its careful assessment of COMIRNATY. We thank both the Commonwealth Government and the Department of Health for their strong partnership to bring our vaccine to Australians.

“We are proud to be part of this breakthrough, which was made possible through unparalleled collaboration between companies, governments, regulators, public health bodies, and the academic and scientific communities coming together urgently to find solutions to the pandemic,” Harris said.

Chief Business Officer and Chief Commercial Officer at BioNTech Sean Marett said, “It is encouraging to see that our mRNA vaccine is now approved in Australia. The number of countries authorising the use of our vaccine is steadily increasing. This is important in order to support addressing this pandemic.

“Together with our partner, Pfizer, we are looking forward to shipping the vaccines to Australia,” Marrett said.

The TGA’s decision is based on a rolling submission including data from the phase 3 clinical study, which demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective), and also in participants with and without prior SARS-CoV-2 infection (second primary objective).

The vaccine has now been granted a conditional marketing authorisation, emergency use authorisation, temporary authorisation or provisional approval in more than 50 countries.

Image credit: ©stock.adobe.com/au/M.Rode-Foto