Paperwork, lengthy tests delaying Australia’s COVID vaccine

Australia’s COVID vaccine rollout is now at risk of further delays — but authorities say the nation can “afford to wait”.

Nurse Justine Williams prepares to vaccinate James Shaw, 82, the first person in Scotland to receive the AstraZeneca shot. Picture: Andy Buchanan

Australia can “afford to wait” and properly test the safety of COVID-19 vaccines, one of Victoria’s top health experts says.

It comes as paperwork hold-ups jeopardise the federal government’s intended March rollout of coronavirus jabs.

Deputy chief health officer Allen Cheng said safety and effectiveness tests are key factors being considered before the rollout of the vaccine in Australia, despite it being available in other countries.

“Ultimately, the question is whether the benefit of using the vaccine outweighs the known risks and the uncertainties,” he wrote on Twitter.

“Countries where there are hundreds or thousands of deaths each day are clearly willing to tolerate some uncertainty to prevent this, and this is appropriate.

“But we’re in a different position in Australia – even with the current situation in NSW and VIC, we can afford to wait for the TGA to do its job and make sure we’re getting a safe, effective and quality vaccine.”

Professor Cheng said the vaccine must undergo lengthy regulatory approvals to ensure it effectively prevents the virus and lowers the risk of transmission before it is distributed in the community.

Victorian Deputy chief health officer, Allen Cheng. Picture: NCA NewsWire / Ian Currie

“Safety requires larger numbers of participants in trials. What we’re looking for is a ‘safety signal’ — anything that might hint that something serious might be caused by a vaccine, and how common it is,” he said.

“We look at common side effects, severe side effects, those severe enough to discontinue the course, deaths that occur after vaccination, lab abnormalities. For COVID vaccines we want to make sure the vaccine doesn’t make severe disease worse.”

AstraZeneca’s coronavirus vaccine rollout in Australia was planned for March but has been jeopardised by a delay in delivering essential data to the ­federal government.

It’s fallen behind the registration timeline of the rival Pfizer jab which could be ­approved this month.

The Herald Sun can reveal that the Therapeutic Goods Administration is not expecting to grant AstraZeneca a provisional registration until February.

But the TGA anticipates Pfizer will move to the next stage by the end of this month.

This is despite AstraZeneca getting through the initial provisional determination step five days earlier, in October.

Paperwork appears to be the impediment.

“The TGA is expecting further data from AstraZeneca in regard to their COVID-19 vaccine in late January 2021,” an administration spokeswoman said.

Vaccines must undergo a lengthy approval process. Picture: Geoff Caddick/AFP

“Australia is on track to have the Pfizer COVID-19 vaccine provisionally registered by the end of January 2021, subject to regulatory requirements being met.”

An AstraZeneca spokeswoman said it didn’t determine timings.

“AstraZeneca is continuing to provide data to the TGA for them to consider,” she said.

Commonwealth chief medical officer Paul Kelly said “the approvals will happen when all the information we need to make those approvals is ­available.

“That will be fast-tracked as much as possible but no shortcuts will be made,” Professor Kelly said.

“The safety check has to be there before anyone gets this vaccine in Australia. There will be no delays to the rollout of coronavirus vaccine — other than those which are absolutely necessary for safety.”

Prime Minister Scott Morrison said Australians would expect all normal safety procedures to be followed.

“We are moving this as swiftly as it safely can be done,” he told 3AW.

“Australia is not in an emergency situation like the United Kingdom so we don’t have to cut corners, we don’t have to take unnecessary risks.

“We are learning a lot from some of the issues that are presenting themselves and the confusion in particular that is there about doses and distribution and administering of the vaccines.

“But they are in a position where they have no other choice because of the terrible situation they find themselves in.

“Now in Australia we are not in that situation, so it is important that Australians have total confidence in the vaccine and that requires all the proper processes to be followed.”

When asked if criticism about the vaccine rollout timeframe from the federal Labor was fair, Mr Morrison said Anthony Albanese was “uninformed” and had not accepted briefings offered to him by the government.

“It is an uninformed view,” Mr Morrison said. “They were offered a briefing in December, which wasn’t taken up.

“I think the last briefing the shadow health minister (Chris Bowen) had was in November.

“What’s informing his views is only for him to explain because he certainly hasn’t been sitting down with our officials who are running this process and the medical professionals who are working to pull together all of the information they need to make the decision on the vaccine.”