Pfizer COVID-19 vaccine provisionally approved for Australian use

The provisional approval is for individuals 16 years of age and older, with two doses required at least 21 days apart. It is a temporary approval to meet public need, where the benefits of early approval outweigh the risks.

For the very frail – people aged over 85 – the TGA recommends doctors vaccinate on a “case-by-case basis”, as the potential benefits of the vaccine must be weighed against the risks of exposing a very frail person to the vaccine’s standard flu-like side-effects.

About 80,000 doses will be administered a week from late February and the rate will increase once the doses manufactured in Australia – which will peak at 1 million doses a week – can be distributed. The rollout is expected to be completed in October.

“Around August last year we took the decision that we didn’t want to be in a situation where we were completely reliant on the production of vaccines overseas,” Mr Morrison said. “We put the arrangements in place to ensure we would be able to produce our own vaccine here in Australia and that is happening now.”

He said Australia “paid a premium” for the capabilities and that the federal government was involved more broadly in the development of vaccine production facilities in Melbourne.

“That was the right decision for Australia because, as much as you can, you want to be able to control as many things as you can in this country when dealing with COVID-19.”

Mr Morrison said the logistical challenge of distributing the vaccine in a country of Australia’s size would be significant.

“There will be swings and roundabouts in the process,” he said. “You can also expect for us to explain those as they occur.”

Foreign Affairs Minister Marise Payne has started working with Australia’s Pacific islands neighbours on preparations to administer the COVID-19 vaccine in the region.

“I have had some fantastic messages back from Pacific leaders over the course of the last week,” Mr Morrison said. “They are appreciative of the proactive role that Australia has taken to ensure that they will be in a position to administer that vaccine.”

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

“The TGA’s processes are, I believe, the best in the world and we have ensured that they are thorough,” Mr Hunt said. “The TGA has placed safety above all else.”

The head of the TGA, Adjunct Professor John Skerritt, thanked the clinical and medical officers, scientists, pharmacists and experts in statistics, laboratory analysis and manufacturing assessment who “have worked tirelessly” on assessing the vaccine.

The vaccine was approved after a phase 3 trial, in which 43,651 people aged over 16 were enrolled.

Of the 36,523 people eligible for the interim analysis, there were 170 confirmed cases of COVID-19 – 162 of them in people given the placebo.

These large numbers allow scientists to be confident in their findings. The TGA’s analyses puts the vaccine’s effectiveness at preventing symptomatic COVID-19 at 95 per cent – or, to put that another way, there is a 97.5 per cent chance the vaccine’s efficacy is at least 90.3 per cent.

However, there are many unknowns –this is a provisional approval, rather than full registration.

It remains unclear if the vaccine will have any effect on reducing the transmission of the virus. It also remains unclear what effect the vaccine has on asymptomatic COVID-19, as people in the trial were only tested for COVID-19 if they had symptoms.

It also remains unclear just how long the vaccine will be effective. In monkeys, declining antibody and immune-cell levels after five weeks were noted.

Doctors will also need to decide whether to inoculate pregnant women, people with autoimmune disorders and those with compromised immune systems, as the TGA says there is limited human data to guide advice.