TGA approves Pfizer and BioNTech's COVID-19 vaccine

The Therapeutic Goods Administration (TGA) has granted provisional approval to Pfizer Australia for its COVID-19 vaccine, developed in partnership with BioNTech, making it the first COVID-19 vaccine to receive regulatory approval in Australia.

Following a thorough and independent review of Pfizer’s submission, the TGA decided that the mRNA-based vaccine meets the high safety, efficacy and quality standards required for use in Australia. The provisional approval means the vaccine, 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. Two doses will be required, at least 21 days apart.

The TGA’s decision is based on a rolling submission including data from a 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), in each case measured from seven days after the second dose. Efficacy was consistent across age, gender, race and ethnicity demographics, with an observed efficacy in adults aged >65 of more than 94%. There have been no safety concerns reported by the Data Monitoring Committee to date.

Provisional approval of the 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. It is also not yet known whether COMIRNATY prevents COVID-19 transmission or asymptomatic disease.

Pfizer and BioNTech have an agreement with the Australian Government to supply 10 million doses of the vaccine, which will be distributed to priority groups as identified by the Department of Health with guidance from the Australian Technical Advisory Group on Immunisation (ATAGI) COVID-19 Working Group — including aged-care and disability-care residents and workers, frontline healthcare workers, and quarantine and border workers. While the government had previously flagged that vaccination could potentially begin by mid-February, Pfizer has experienced some temporary production delays from its European manufacturing plant and so commencement is now projected for the end of the month, or early March at the latest.

“I welcome the TGA’s approval of the Pfizer vaccine, with our own Australian experts finding it is safe, effective and of a high standard,” Prime Minister Scott Morrison said.

“Our priority has always been to keep Australians safe and protect lives and livelihoods. Today’s approval is another big step forward for our community, particularly in the protection of our most vulnerable people.”

Minister for Health Greg Hunt said the-world class regulators at the TGA have been working tirelessly to introduce a safe and effective COVID-19 vaccine in Australia.

“Australia’s high bar has been met; the vaccine has been approved as effective in stopping severe disease,” Hunt said. “I thank all those involved in the development and assessment of this COVID-19 vaccine, including the researchers, Pfizer, BioNTech and the medical experts at the TGA who have worked around the clock and over Christmas.”

Adjunct Professor John Skerritt, Head of the TGA, said the organisation has been working non-stop to get the Pfizer vaccine assessed, while maintaining the most rigorous standards of safety, quality and efficacy — and the job is by no means over.

“The monitoring of vaccine safety post-approval is an important part of the regulatory review of vaccines,” Adjunct Professor Skerritt said.

“We now check the individual batches of vaccines that are destined for Australians while closely monitoring the safety and efficacy of the vaccine as it is rolled out.

“We will also continue our work on the regulatory review for potential approval of other vaccines, notably the AstraZeneca and Novavax vaccines, as well as vaccines delivered through the COVAX Facility.”

In total, Australia has secured 140 million doses of vaccine from various suppliers — one of the highest per-capita rates in the world. The vaccine will be rolled out in five phases over the coming months and, over time, will involve more than 1000 vaccination administration sites.

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

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