Pfizer COVID vaccine first to be approved in Australia

The Therapeutic Goods Administration (TGA) has granted provisional approval for the Pfizer/BioNTech COVID-19 vaccine, clearing the way for its use in people aged 16 and older.
 
The approval comes a year to the day after Australia registered its first cases of COVID-19.
 
The vaccine, which requires two doses at least 21 days apart, is the first candidate to be approved for use in Australia.
 
Australia has purchased 10 million doses of the Pfizer/BioNTech vaccine – enough to vaccinate 20% of the population. The first phase of the vaccine rollout will be aimed at priority groups, including those over 70, adults with existing medical conditions, and Aboriginal and Torres Strait Islander people.
 
Prime Minister Scott Morrison has welcomed the news, though he indicated the country’s planned vaccine rollout will be slightly delayed.
 
‘We are more looking at late February now than mid-February because of the challenges that we have seen in the production and delivery for both AstraZeneca and Pfizer around the world,’ he said in a press conference.
 
‘Australia has taken the time, we have been watching and learning from the experience overseas and so we remain within the guardrails of the timeframe that we set a few weeks ago – but that will continue to come under challenge for events and circumstances that exist well beyond our shores.’
 
Several European countries have said supplies of the vaccine have fallen short of their orders.
 
The TGA’s decision is based on a rolling submission of data from Pfizer/BioNTech’s phase 3 clinical study, which demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective), and also in participants with and without prior SARS-CoV-2 infection (second primary objective), measured from seven days after the second dose.
 
‘The TGA’s processes are, I believe, the best in the world and we have ensured that they are thorough,’ Federal Health Minister Greg Hunt said.
 
‘This approval and the upcoming rollout of the vaccine will play an important part in our ability to manage the pandemic in 2021.’
 
Infectious diseases physician and Director of Infectious Diseases at Mater Health Associate Professor Paul Griffin told newsGP the approval is ‘great news.’
 
‘It was a challenging situation with many calls to bring approval forward and many people hesitant. Our regulator has clearly done its due diligence to make sure this is the right thing to do,’ he said.
 
‘To reflect on vaccine development, it’s been extraordinary that there have been so many good candidates going all the way through clinical trials and licensing in record time and without skipping any steps to make sure they’re safe and effective.’
 
Associate Professor Griffin said the effectiveness of the vaccines will be ‘very much dependent’ on uptake and encouraged Australians to be informed and propagate accurate information to ensure as many people as possible get vaccinated.
 
Dr Diego Silva from Sydney Health Ethics in the University of Sydney School of Public Health said the next step in Australia’s vaccine process is ‘for the Commonwealth and states to clearly and transparently articulate the plan for the distribution of the vaccines’.
 
‘In order to engender the public’s trust in the Pfizer and subsequent vaccines, including the trust of healthcare workers, it will be critical for the TGA to describe the pharmacovigilance system they’ll deploy to catch and analyse the negative side-effects that will occur as part of Australia’s rollout,’ he said.
 
‘As we saw last week with Norway and the deaths of those over the age of 80 who received the vaccine, the ability to quickly collate and analyse adverse events is critical for ensuring confidence in both the vaccine, as well as the policy and programmatic processes necessary to deliver the vaccine.’

Prime Minister Morrison was also keen to point out the news of an approved vaccine, while very encouraging, does not represent a ‘silver bullet’ that will allow people in Australia to stop being COVID-safe.
 
‘I have a simple message to Australia: thank you, Australia,’ he said. ‘Thank you that you have put us in a situation that is the envy of most countries in the world today. We intend to keep it that way. We intend to remain vigilant.
 
‘Once the vaccines start, that doesn’t mean you can jump on a plane to Bali the next day, that the masks or the quarantine arrangements disappear.
 
‘This will build, it will start at a small scale, but it is not a silver bullet.’
 
The Federal Government last week announced general practices interested in taking part in the vaccine rollout can submit expressions of interest (EOI).
 
Federal Health Minister Greg Hunt said the Australian Government is seeking EOIs from all accredited general practices, with the eventual aim being to have more than 1000 distribution points spread across the country.
 
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