It’s hard to believe it was a year ago today that the first COVID-19 case was recorded in Australia. But here we are one year later and Australia now has its first approved COVID vaccine. On January 25 the Therapeutic Goods Association (TGA) provisionally approved the Pfizer/BioNTech COVID-19 vaccine for use in Australia with a rollout set for late February.
What is the Pfizer vaccine?
The Pfizer and BioNTech vaccine which was approved today is said to have 90% efficacy according to its Phase 3 trials. The Moderna vaccine is also reporting around 90% efficacy and the AstraZeneca rate is around 70%.
The Pfizer candidate is also an mRNA vaccine, which is different from a traditional vaccine as it doesn’t actually inject the person with a part of the virus. Instead, it gives the user genetic material that encodes the viral protein. This essentially gives the body’s immune system the chance to design antibodies that will neutralise the virus if infected.
The Pfizer vaccine has been shown to prevent COVID-19 but it’s not yet known whether it prevents transmission or asymptomatic infections.
Vaccine approval in Australia
There are currently a number of vaccine candidates rolling out around the world. Some of the more commonly heard of vaccines such as Pfizer, Moderna and AstraZeneca are already being distributed. However, these vaccines were approved for emergency use in countries where the virus is still out of control.
In Australia, we’ve been waiting for the TGA to approve these potential vaccines for recommended use. The Pfizer/BioNTech is the first COVID-19 vaccine to meet regulatory approval and means it can be legally distributed here.
The TGA said in its statement that “Australians can be confident that the TGA’s review process of this vaccine was rigorous and of the highest standard.”
The organisation will continue to monitor the safety of the vaccine and the TGA laboratories are going to undertake an assessment on each batch of the vaccine before it is supplied in Australia.
The approval is valid for two years and requires Pfizer to continue to provide the TGA with information on long term efficacy and safety from its ongoing clinical trials.
Prime Minister Scott Morrison commented on this latest approval.
“I welcome the TGA’s approval of the Pfizer vaccine, with our own Australian experts finding it is safe, effective and of a high standard,” the Prime Minister said in a statement.
“Australians should take confidence in the thorough and careful approach taken by our world-class safety regulator.”
Minister for Health Greg Hunt also backed the approval, saying “The TGA’s processes are I believe the best in the world and we have ensured that they are thorough.”
The TGA has provided more information about the vaccine approval in the AusPAR report and on its COVID-19 vaccine hub.
How and when will the vaccine rollout work?
The TGA has approved the Pfizer vaccine for use in individuals 16 and older. The vaccine will require two doses at least 21 days apart.
The first doses are expected to be administered as soon as they are shipped and tested in late February but any shipping or production delays could push this to early March.
In Australia, the vaccine is expected to be rolled out in five stages. The government’s national strategy includes these phases:
- Phase 1a: quarantine and border workers, frontline health care worker sub-groups, aged care and disability care staff and residents.
- Phase 1b: elderly adults aged 80 years and over, elderly adults aged 70-79, other health care workers, Aboriginal and Torres Strait Islander people over 55, younger adults with underlying medical conditions or a disability, critical and high-risk workers including defence, police, fire, emergency services and meat processing.
- Phase 2a: adults aged 60-69 years, adults aged 50-59 years, Aboriginal and Torres Strait Islander people 18-54, other critical and high-risk workers.
- Phase 2b: Balance of adult population.
- Phase 3 – Under 18-year-olds if recommended.
The Australian government has secured at least 10 million doses of the Pfizer vaccine and 140 million doses of COVID vaccines in total.