greg hunt
(Image: AAP/James Ross)

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.”