Coronavirus: Vaccine rollout for five million Aussies tipped for March

The regulator of medicines in Australia expects to be able to approve the first coronavirus vaccine in late January.

Therapeutic Goods Administration head John Skerritt.

The regulator of medicines in Australia has confirmed it expects to be able to approve the first coronavirus vaccine in late January, with jabs of five million people to begin in March.

That’s provided safety and efficacy data provided by pharmaceutical company Pfizer — which is manufacturing the frontrunner vaccine – meets rigorous regulatory standards. The head of the Therapeutic Goods Administration, John Skerritt, on Wednesday confirmed the news first reported by The Australian that Pfizer had been granted a provisional determination for its vaccine, which fast-tracks the approval process.

A vaccine being developed by AstraZeneca in conjunction with Oxford University has also been granted a provisional determination and is expected to be available in Australia in January, with vaccinations to begin in March if clinical trials prove successful and regulatory approval is granted.

The provisional determinations mean the TGA is already liaising with the pharmaceutical companies, examining data and co-­ordinating with overseas regu­lators to cut time to approval.

“I’m hoping that, all going well, that by, say, the end of January, we’ll be in the position to be able to give the first couple of vaccines an approval,” Professor Skerritt said.

The TGA is also in discussions with “at least a dozen” other companies that are developing coronavirus vaccines to speed up the regulatory process should any of those vaccines prove successful.

There are more than more than 200 COVID-19 vaccines in development globally, with 41 of those in human clinical trials. Ten vaccines are in the final phase of human trials, with hundreds of thousands of volunteers now being injected with vaccines or placebos.

Pfizer released interim results from its phase-three clinical trials in a press release on Monday, reporting that its vaccine had 90 per cent efficacy in tens of thousands of people involved in its clinical trial.

Pfizer, which is developing the BNT162 vaccine with German partner BioNTech, has enrolled 43,538 participants in its phase-three trial. The trial began on July 27 and, so far, 38,955 people have received two doses of the vaccine.

During the trial, 94 people have contracted COVID-19, but only 10 per cent of those received the vaccine rather than a placebo. ­Pfizer said it would continue the trial until there had been 164 confirmed cases of COVID-19 among participants.

The company said it expected to be able to provide the US Food and Drug Administration with the required amount of safety data for emergency-use authorisation of the vaccine by the third week of November.

Federal Health Minister Greg Hunt said Australia had secured cold-chain logistics for the Pfizer vaccine, which must be refrigerated to -70C. The vaccines will be transported to Australia in “very sophisticated eskies” and cooled by dry ice. The vaccines last 14 days refrigerated in the dry ice containers, which means they will be able to be distributed to GP clinics and administered there.

“We are on track to deliver vaccines to Australians, commencing in March of 2021,” Mr Hunt said. “We want to see all Australians have the option of being vaccinated during the course of 2021. Our distribution process is set up to achieve that.”

Health workers, the elderly and aged-care workers are in line to ­receive jabs first.