Health Minister Hunt Says Australia Patiently Awaits ‘Safety Assessment’ as UK Fast-tracks Pfizer CCP Virus Vaccine
“Our advice remains that the timeline for a decision on approval is expected by the end of January 2021, and our planning is for first vaccine delivery in March 2021,” Hunt said in a statement on Dec. 3 while welcoming the UK’s decision.
On Wednesday American conglomerate Pfizer and Germany-based BioNTech became the worlds first to have their COVID-19 vaccine approved as the UK’s Medicines and Healthcare products Regulatory Agency allowed for a temporary rollout within the coming days. Only a limited amount of jabs have been authorised, and they are reserved for specific groups such as frontline healthcare workers, and the elderly population.
The deal with the UK government, according to Pfizer, is for the distribution of around 40 million doses throughout 2020 and 2021.
The Australian government has a deal for 10 million doses of Pfizer’s BNT162b2 vaccine but will await authorisation from its independent regulators before moving to distribution.
The Therapeutic Goods Administration is still acquiring data about safety and efficacy from Pfizer Australia Pty Ltd about its mRNA type jab as part of the approval process, Hunt said.
“Safety is our number [one] priority, and Australia is well placed both for a thorough, but rapid safety assessment and early rollout of a free, voluntary but entirely universally available COVID-19 vaccine program,” he noted.
Results from Pfizer’s phase three trials, suggests that the BNT162b2 vaccine is 95 percent efficient. However, the trials do not exceed six months of treating COVID-19.
Professor Dale Fisher, Chair of the World Health Organisation’s Outbreak Alert and Response Network says Australia is in an excellent position to see how the data plays.
He said there is no need to rush, due to the meagre rate of infection in Australia we can sit back a little and let the dust settle, but recognised that in the UK the virus is out of control.
“You wouldn’t’ want to vaccinate a whole country urgently and then realise that it doesn’t work after a few months and you have to redo everyone,” Fisher told 3AW on Thursday. “There’s a big difference between two months and six months of data.”
While explaining what data regulators are looking for he said, its essential to know how long the vaccine protects people. “Most side effects from a vaccine are likely to come in the first couple of months,” it would be interesting to see the efficacy after beyond four months, he added.
Pfizer and BioNTech have also sought approval from the Food and Drug Administration and the European Medicines Agency (EMA). The EMA will decide on Dec. 29 if their vaccine will be approved.
U.S. biotech company, Moderna have been told to wait till Jan. 12 to hear if they will be approved to roll out their vaccine.
Emergency applications in America and Europe come as the second wave of the pandemic is continuing to worsen.
The United States has recorded over 2,400 deaths due to COVID-19 in the last 24 hours, bringing the total close to 270,000, according to the Centre for Disease Control and Prevention. In the UK, they have registered 648 virus deaths, and the tally is just short of 59,700.
The last death Australia attributed to COVID-19, a woman in her 80s, occurred last week—the total Australian death toll being 908.