PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Pfizer Australia Pty Ltd. for its COVID-19 vaccine, branded Comirnaty, making it the first COVID-19 vaccine to receive approval in Australia.

The provisional approval for the Pfizer Inc./Biontech SE COVID-19 vaccine means that the vaccine is now included in the Australian Register of Therapeutic Goods (ARTG) and can be legally supplied in Australia for two years.

Comirnaty is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 and older.

The provisional approval is subject to certain conditions, such as requiring Pfizer to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and postmarket assessment. The sponsor can apply to transition to full registration at any time up until the provisional registration lapse date, once it has completed the obligations outlined for the provisional registration period and complete confirmatory data on safety and efficacy are available.

Comirnaty has been shown to prevent COVID-19; however, it is not yet known whether it prevents transmission or asymptomatic disease, the TGA said.

The vaccine is not recommended for those under 16. Those who have severe allergy problems, frail elderly, patients with impaired immune systems and pregnant and breastfeeding women will be assessed on a case-by-case basis by clinicians.

“The TGA will continue to actively monitor the safety of the Pfizer vaccine both in Australia and overseas and will not hesitate to take action if safety concerns are identified,” the TGA said in a statement. “As an extra check, the TGA laboratories will undertake batch assessment of each batch of the vaccine before it can be supplied in Australia.”

In documents posted to the TGA website, the agency said the continued approval “depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and postmarket assessment.”

The provisional approval includes the following post-approval commitments:

  • Additional data should be provided in relation to the reference standards and materials;
  • Additional stability data should be submitted as it becomes available. Once additional data have been submitted to the TGA for evaluation, an extended shelf life or change in storage conditions may be considered;
  • A commitment is required not to supply any batches that have a temperature deviation during shipment;
  • Additional information should be provided regarding batch analyses;
  • Additional data should be provided in relation to process validation of commercial scale batches;
  • Additional data should be provided for the proposed rapid sterility test; and
  • Study data from a leachables study, which examines the migration of mobile chemicals from components used in the manufacture and storage of the vaccines, should be provided.

Rollout the next big question

“The only potential problem now is whether Pfizer can supply the purchased 10 million doses on time. Supplies are already being delayed in Europe, with scheduled supplies being halved in some European countries," said Adrian Esterman, chair of biostatistics and epidemiology at the University of South Australia.

The next critical step will be for the Commonwealth and States to “clearly and transparently articulate the plan for the distribution of the vaccines,” said Diego Silva, a lecturer in bioethics in the University of Sydney School of Public Health.

To gain the public's trust in this vaccine as well as subsequent vaccines, “it will be critical for the TGA to describe the pharmacovigilance system they'll deploy to catch and analyze the negative side effects that will occur as part of Australia's rollout, he said.

“As we saw last week with Norway and the deaths of those over the age of 80 who received the vaccine, the ability to quickly collate and analyze adverse events is critical for ensuring confidence in both the vaccine, as well as the policy and programmatic processes necessary to deliver the vaccine."

“The Australian Government has secured more than 50 million doses of the Oxford/Astrazeneca vaccine, so this vaccine should also be approved quickly to start a mass vaccination program,” said Abrar Chughtai, director of the Master of Infectious Diseases Intelligence program in the School of Public Health and Community Medicine at UNSW Sydney.

“We also need to keep an eye on the new COVID variant in the U.K., which is more transmissible and, according to some recent data, more deadly as well. It is still not clear whether current vaccines will be effective against the new strain or not.”

The vaccine will be rolled out in five phases, starting with quarantine and border workers, front-line health officials, and those working in aged care and disability care followed by residents in aged care and disability care.

Prime Minister Scott Morrison said he hoped to begin the process with around 80,000 vaccinations per week, and to reach 4 million people by the end of March. He said this process would provide the most necessary “ring of containment and protection” for the Australian population, which is roughly 25.5 million.

About 30 to 50 vaccine hubs will provide early support across these priority groups that will get the Pfizer vaccine.

The Astrazeneca vaccine and then the Novavax Inc. vaccine will be subsequently rolled out across more than 1,000 locations across Australia that will work in conjunction with the states to distribute vaccines.

The Astrazeneca vaccine will be manufactured onshore at CSL Ltd.’s manufacturing facility in Victoria, and once that is cleared, distribution will be expanded to the next higher-risk group comprising indigenous Australians over age 55, and people with clinical conditions that put them at higher risk. People 55 and older will be the next group, followed by the general population, and then children as the last group to be vaccinated.

Planning and delivery will be done in partnership with the states and territories, Health Department Secretary Brendan Murphy said, stressing that each state and territory has different needs.