The UK’s regulatory body has approved the Pfizer-BioNTech COVID-19 vaccine for use across Britain, making it the first country to do so. Vaccinations will start early next week.
But in Australia, Health Minister Greg Hunt has reiterated approval for a vaccine likely won’t be finalised until January, with vaccinations rolled out from March.
Where are we up to?
Pfizer’s is one of four vaccines the Australian government has purchased, with 10 million doses secured. Two doses are needed for each person.
Independent regulator the Therapeutic Goods Administration (TGA) will make a decision on whether to approve the vaccine. Pfizer has been providing the relevant data for the TGA’s approval.
“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,” Hunt said in a statement.
The US and European Union are also vetting the Pfizer vaccine.
Is the TGA facing a bottleneck?
Director of infectious diseases at Mater Health Services Paul Griffin told Crikey the TGA’s approval process has been sped up to cope with COVID-19.
“There’s a tendency to describe any regulatory process as a bottleneck. But in this case, it’s certainly a process that’s required,” he said.
“We need to have appropriate experts, fully review that data to make sure it’s definitely the right thing to do and not make any assumptions based on other people’s interpretation or other approvals.”
Griffin added many unnecessary waiting times have been shortened. TGA vaccine approval takes close to 200 working days under normal circumstances. Pfizer was permitted to pre-apply for TGA registration to speed up the approval process.
An opportunity for Australia
Associate professor of medicine at the Australian National University Sanjaya Senanayake told Crikey the UK’s approval presented an opportunity for Australia to learn more.
“Phase four trials go on for the life of the vaccine’s use, looking for ongoing issues on effectiveness and safety. We’ll have a few months to see how that goes in the UK,” he said.
The Pfizer vaccine also has to be stored at incredibly cold temperatures, making distribution to those outside a hospital setting a challenge.
In the past 24 hours, the UK recorded 16,170 coronavirus cases and 648 deaths, with more than 1.6 million cases recorded since the pandemic began. Senanayake said these rates likely affected the UK’s regulatory approval time.
“They need a solution fast,” he said.
“I suspect if Australia had a large cluster of cases, the TGA would push things forward a little faster … but if we have an opportunity to wait just a little bit longer, then it’s reasonable to do so.”
Please, take all the time you need, TGA. Get it right. I recall the brave female scientist who prevented a thalidomide baby disaster in the USA when she stood her ground and said no, the safety trials don’t meet the standard, after other countries had already approved the drug for use by pregnant women. So, take your time, be satisfied, I’m happy to wait.
Amen to that. And we need more independent scientists, those who are not part of the “Science Press” to speak up when it comes to the fudged and manipulated covid data.
I’m happy to wait as well. We have an ideal opportunity to see what happens with this vaccine wit the rush to distribute in the UK and the US. Lucky for us we aren’t in the situation the US and the UK are in.
As the article says, this is our very own Phase 4 trial. With just 12 cases in the wild in Australia there isn’t the pressing need here that there is in the Northern Hemisphere where they are approaching a COVID Armageddon. We can sit back and watch what happens when you give it to a couple of million people, rather than a hundred thousand or so. And we’ll see if it’s truly safe, or if it has the side effect profile of paracetomoxyfrusebendroneomycin (Google it).