The Pfizer vaccine has met strict standards for safety, quality and efficacy, a statement from the prime minister’s office said on Monday, and the vaccine has been approved for rollout in Australia for people aged 16 years and older.
The first vaccinations are expected to be in late February and the first 1.4m doses of Pfizer and other vaccines once they are available will go to a priority group that includes quarantine and border workers, frontline health workers in high-risk settings, and aged care and disability staff and residents. This will be administered at hospitals, with the government aiming for 80,000 doses a week.
Next, 14.8m doses will go to elderly adults age 70 and above and to Aboriginal and Torres Strait Islanders over the age of 55. Other healthcare workers; young adults with underlying medical conditions and disability; and critical and high-risk workers including defence, police, ambulance, fire and meat workers will also be vaccinated as part of the second phase.
People age 50 and above and Aboriginal and Torres Strait Islanders age 18 to 54 will receive the next 15.8m doses, along with any other critical and high-risk workers. Everyone else will receive the 16m doses to be rolled out after that, except people aged 16 and under. That group of children and teenagers will be vaccinated last and only if the evidence supports it by then.
Two doses of the vaccines will be required at least 21 days apart. If there are delays in shipping or production, the government said rollout may be delayed until early March.
However the managing director of Pfizer Australia, Anne Harris, said “we are still on track to deliver the first doses of our vaccine late February, and we are absolutely committed to delivering 10 million doses over 2021”.
“But because of the dire need around the world and significant increase in requests for our vaccine, we have made a commitment from delivering 1.3 billion doses in 2021 to now increasing that to two billion doses in 2021,” she said.
The need to increase capacity of manufacturing plants has disrupted some delivery schedules, but Harris said they expected those issues would be resolved by mid-February.
Last year, the Australian government maintained the vaccine rollout would not start until March, but earlier in January revised this to late February amid pressure from the opposition to roll the vaccine out faster.
The prime minister said the vaccine did not mean other public health and hygiene measures would end.
“It is important to understand that once the vaccine starts, that doesn’t mean you can jump on a plane to Bali the next day,” Scott Morrison said. “It doesn’t mean that the masks disappear, if that is what the public health arrangements are in a particular state or territory, or the quarantine arrangements for returning into Australia will end. It will start at small-scale, it will build up and it will happen over a period of time over the course of this year. Of itself, it is not a silver bullet, because there are still limitations to what these vaccines can do.”
Researchers still do not know whether the vaccines can prevent or stop transmission of the virus to other people, or whether they only prevent the vaccinated individual from developing mild through to severe disease. They are not yet clear on how long protection offered by the vaccine will last, and when and whether booster shots will be needed.
The federal health department secretary, Prof Brendan Murphy, said: “What we do know is that the two vaccines that we are rolling out now are both very good at preventing clinical Covid disease and particularly severe disease.
“It may be that people will need additional doses of vaccines, possibly annually. These things are completely unknown at the moment.”
Medical director at Pfizer Australia, Dr Krishan Thiru, said “clearly, the real world experience with any medicine or vaccine is critical to get a full understanding of that medicine”.
“We will work with regulators all around the world to continually monitor and analyse all reports we get, whether it’s safety reporting or others reports, and once there is a critical mass of the population vaccinated we will be able to look at the vaccine’s effect on rates of Covid-19 in the community,” he said. “We need to collect more data from clinical trials and from the real world to know that, and it’s probably a few more months until we will know.”
Pfizer was also continuing to conduct its own studies into younger age groups and people at high-risk.
Morrison said that by the end of March, he hoped 4m doses would have been administered. The approval of the vaccine by drug regulator the Therapeutic Goods Administration was a full and formal approval, he said, and not an emergency approval. It meant the TGA had followed its usual rigorous process for approving new drugs. Other countries, such as the US and the UK, gave emergency approval to roll out the vaccines due to the crisis situation in those countries, approving the Pfizer vaccine before the full clinical data could be reviewed.
The TGA will also quality and safety check the individual batches of vaccines and will continue to monitoring the safety and efficacy of the vaccine as it is rolled out. Other vaccines Australia has signed contracts for, including the AstraZeneca vaccine and the Novavax vaccine, still need to undergo regulator approval. Phase-three clinical trial results for the Novavax vaccine are not yet available, and the TGA will wait to receive this before starting the approvals process.
Morrison said he was hopeful the AstraZeneca vaccine would become available from March, subject to regulator approval, and it had the benefit of being able to be manufactured in Australia, making the logistics of a rollout more straightforward.
However, the health minister, Greg Hunt, said AstraZeneca had advised the government on Sunday that it was experiencing significant “supply shock”.
“So that means we won’t have as much of that AstraZeneca international vaccine in March as they had previously promised,” Hunt said. He said the ability to manufacture onshore would prove critical.
Hunt said Australia had recorded seven consecutive days of no cases of community transmission, which he said was a testament to “all Australians, all governments and all health officials”.
“Every vaccination will be a cause for celebration.”
