Coronavirus vaccine could be approved next week, TGA boss says

Adjunct Professor John Skerritt, who leads the Therapeutic Goods Administration and will make the final sign off, is hopeful the decision could be made ahead of schedule.

A meeting of the government's Advisory Committee on Vaccines was brought forward to Friday afternoon to consider the most recent data from the manufacturer and the regulator.

Staff at the regulator will work through the weekend following the meeting, but Professor Skerritt said he couldn't predict an exact timeline after that.

"I'm hoping by this time next week, we'll actually have a decision on the first vaccine," Professor Skerritt told The Canberra Times ahead of the meeting on Friday.

"[The committee] will meet, they'll look at all the information our experts have put in, the recommendations and questions."

While hopeful of an imminent decision, Professor Skerritt said it was partly out of his hands, as they relied on information coming from the company.

"That committee certainly will have some questions, or some comments. They have to go back to both our people to look at it and to Pfizer. I'm hoping that will happen very soon after the meeting, and again, my poor people probably be doing it on Saturday and Sunday.

"And then hopefully, we'll get a quick response from Pfizer, and then hopefully, we'll be able to make a decision next week."

The Therapeutic Goods Administrator has been in a race against time to make decisions about the two major vaccines set to be rolled out in Australia, with staff working around the clock to assess the vaccines for efficacy, safety and manufacturing quality and safety.

The initial vaccine rollout, originally slated for March, has been brought forward to February, a decision that was made in consultation with the regulator.

Australia is set to import 10 million doses of the Pfizer vaccine, which is required to be kept at ultra cold temperatures, below -70 degrees Celsius.

Professor Skerritt said he expected a decision to be made on the AstraZeneca vaccine, of which Australia has ordered 53 million doses, in February.

Three vaccines are currently being considered under the regulator's provisional determination process, meaning the assessment is prioritised within the regulator, and the approval, when given is like being on "P plates," Professor Skerritt explained, with full approval to come in the coming years.

"We've got most data on Pfizer. We've got the second most on AstraZeneca and we've got third most on the Janssen product," he said.

A fourth vaccine could enter the process as early as next week.

Experts at the regulator worked through the Christmas and New Year shutdown period to assess the vaccines, looking at more than 10,000 pages of data on each vaccine, as well as testing the product in the laboratory.

Despite the intense speed involved, the regulator hasn't cut corners in the process, Professor Skerritt said, and the government has hit back at any suggestion rollout should be accelerated with an emergency approval like in the United Kingdom and United States.

As part of the decision to be published by the regulator, a Public Assessment Report will also be published, telling health professionals what is known about the vaccine, how it should be administered, and what groups it is appropriate to be used for. It will also list what uncertainties still exist about the vaccine, like how long it will provide protection against COVID-19 for, questions Professor Skerritt expects will be answered in coming months.

The Advisory Committee on Vaccines is chaired by Professor Allen Cheng, who is also on the Australian Technical Advisory Group on Immunisation, which advises the government on the rollout of the vaccines.

It is unclear if approval is made next week, earlier than first expected, whether the vaccine rollout timetable will come forward again.

Pfizer is not set to start shipping its product to Australia until the approval is given, and it is expected to take the vaccines two weeks to be shipped to the country.

A spokesman for Health Minister Greg Hunt welcomed the news the vaccine approval is imminent.

"If approved, this would be very positive news for Australia," he said.

"Australia has arguably one of the best regulators in the world. The TGA conducts an independent process, and that process is still on-going."

He did not say whether it would affect the rollout, scheduled to start in mid to late February.

"In the mean-time the government is continuing to plan for the vaccine roll-out."

A spokeswoman for Pfizer also gave little detail on whether an approval within days could change their plans.

"Pfizer and BioNTech are committed to delivering on their agreement with the Australian government to supply 10 million doses of their vaccine candidate for COVID-19 over the course of 2021, subject to regulatory approval," the statement said.

"During the initial pandemic stage, our contracts are with the government, and we will provide doses according to the government's preferred channel and designated locations."

"The timing of access to the Pfizer-BioNTech vaccine candidate is subject to regulatory approval by the TGA. Our role is to ensure that, if our vaccine candidate is authorised for use, we supply our vaccine doses through a robust process, consistent with the agreement we've entered into with the Australian government."