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TGA approves Pfizer/BioNTech COVID-19 vaccine ahead of rollout

Monday 25, Jan 2021

The Therapeutic Goods Administration (TGA) has provisionally approved the Pfizer/BioNTech coronavirus (COVID-19) vaccine for use in Australia. The TGA provisional approval is for individuals 16 years of age and older, with two doses required at least 21 days apart. As the vaccine rollout begins across 30–50 hospital sites, people who need protection the most will get the vaccine first. This includes aged-care and disability-care residents and workers, frontline healthcare workers, and quarantine and border workers.

The priority groups have been determined based on the advice of the Australian Technical Advisory Group on Immunisation (ATAGI), which oversees Australia’s immunisation program. The latest advice from Pfizer is that shipping and the first vaccinations are expected to be in late February. However, delays in shipping or production could see the rollout commence in early March.

Minister for Health Greg Hunt said the regulators at the TGA have been working tirelessly to introduce a safe and effective COVID-19 vaccine in Australia, adding that the approval of the Pfizer/BioNTech vaccine is a big step forward for the community. “There is intense ongoing work which will continue over the coming month, including batch testing of newly arrived doses, establishing cold storage facilities for the vaccine, training health providers to administer it, finalising distribution sites with states and territories, checking sites and protective equipment for safety, and scaling up systems for ongoing safety monitoring,” Hunt said.

The Australian Government is working with Pfizer to finalise the date of delivery of the vaccine, noting that Pfizer has experienced some temporary production delays from its European manufacturing plant as it increases production to meet global demand. In Australia, the vaccine will be rolled out in five phases, involving more than 1000 administration sites. “Australia’s vaccination program has been based on the medical advice from the medical expert panel led by Professor Brendan Murphy,” Hunt said. “As a result we are in the fortunate position of having secured 140 million doses of vaccine, one of the highest per-capita rates in the world. We will continue to review the medical advice and monitor and adapt to developments around the world.”

The Head of the TGA, Adjunct Professor John Skerritt, said the TGA has been working non-stop to get the Pfizer vaccine assessed, while maintaining rigorous standards of safety, quality and efficacy. Adjunct Professor Skerritt also expressed his gratitude for the TGA’s clinical and medical officers, scientists, pharmacists and experts in statistics, laboratory analysis and manufacturing assessment. “Our job is by no means done,” Adjunct Professor Skerritt said. “In fact, the monitoring of vaccine safety post-approval is an important part of the regulatory review of vaccines. We will also continue our work on the regulatory review for potential approval of other vaccines, notably the AstraZeneca and Novavax vaccines, as well as vaccines delivered through the COVAX facility.”

National Cabinet

The Australian Health Protection Principal Committee (AHPPC) has provided advice that state and territory public health orders should not be utilised to require the COVID-19 vaccine for aged-care workers at this point. During a meeting on 22 January 2021, the National Cabinet agreed with the interim AHPPC advice on COVID-19 vaccination and aged-care facilities. The AHPPC has advised that Commonwealth and jurisdictional efforts should focus on communications to strongly encourage community uptake, which is expected to be high. There is currently a lack of evidence regarding the efficacy of transmission prevention, and there is not yet a clear date by which all residents, staff, visitors and carers will have had an opportunity to be vaccinated. The AHPPC will monitor the situation and reconsider this matter once further evidence becomes available.

During the National Cabinet meeting, Acting Chief Medical Officer Professor Michael Kidd provided an update on the latest epidemiological data and medical advice in relation to COVID-19. Professor Kidd revealed that through the actions of every Australian, a third wave of infections has been successfully prevented, with six days in a row of zero cases of local transmission. National Cabinet has also reaffirmed its commitment to the Australian COVID-19 Vaccination Policy, which details the roles and responsibilities of the Commonwealth, states and territories in rolling out the vaccine. Professor Murphy, who is Chair of the COVID-19 Science and Industry Technical Advisory Group, provided an overview of the arrangements underway to develop the Australian Vaccination Strategy and prepare for the rollout of COVID-19 vaccines to priority groups.

National Cabinet noted the development of the vaccination program implementation plan and reiterated the importance of close cooperation between the Commonwealth, states and territories on the rollout. National Cabinet has also reaffirmed its commitment to return international passenger arrival caps to previous levels on 15 February 2021. National Cabinet will also prioritise the return of Australians, with a shared focus on improving confidence in quarantine capacity to accommodate returning Australians. The Australian Government, states and territories, regulators, and the health and medical sectors are working together to finalise arrangements under the Australian Vaccination Strategy and detailed rollout plans. 

Image credit: ©stock.adobe.com/au/Ekaterina_1525