PM Scott Morrison ships a million doses of Pfizer, despite only 'provisional approval' from TGA

Australian Prime Minister, Scott Morrison, announced over a million doses of Pfizer has been shipped from Poland after approval from the Therapeutic Goods Administration (TGA), yet failed to mention the approval was only 'provisional'.

'These doses are all from one batch of the vaccine produced from the same plant in Europe as other doses of this vaccine imported directly by Pfizer Australia," the TGA said in a media release.

'The TGA has reviewed all batch release and transportation (and) cold chain documentation as satisfactory for release'.

Although the tick of 'provisional' approval may sound like the label confirms the safety of the vaccine by the governing body, it is apparent after reading the TGA's statement that the Pfizer-BioNTech COVID-19 vaccine is permissible for trial only - and potential error.

Included in the provisional approval document posted on the TGA'S website is an overview of the current trial which includes information such as 'post-marketing experience' stating the trial results are currently in process with the outcome as yet unknown.

'Although the events listed in Table 2 were not observed in the clinical trials, they are considered adverse drug reactions for COMIRNATY as they were reported in the post-marketing experience. As these reactions were derived from spontaneous reports, the frequencies could not be determined and are thus considered as not known'.

The TGA's provisional approval for the vaccine trial overview is posted on their website

The TGA provisional approval report for the Pfizer-BioNTech COVID-19 vaccine serves to confirm Health Minister Greg Hunt's statement that we are partaking in a vaccine trial.

'We are engaged in the world's biggest clinical trial, the world's largest vaccination trial ever, and we will have enormous amounts of data.' he said.

'We are engaged in the world's biggest clinical trial, the world's largest vaccination trial ever, and we will have enormous amounts of data'.

The Polish embassy in Canberra told media their government was not making a profit from the sale of the Pfizer doses to Australia, and that the country hoped to support efforts to combat the current NSW break out.

'Poland has recently offered to share vaccines mainly with low and middle-income countries, including its Eastern neighbours, Balkan countries etc.

'The decision to also add Australia to the list was taken against the backdrop of the current outbreak of Delta variant in the country, following the talks between both countries' officials, including the Prime Ministers and Foreign Ministers'.

Mr Morrison disclosed he has been in discussions with the Polish government for some time to secure the vaccine.

'We have been in discussions with the Polish government now for several weeks, and we have secured over an additional one million doses of Pfizer, which will start landing in Australia from tonight,' he said.

'And of course, we will be ramping up again significantly in the fourth quarter of this year.

'These one million doses, will give hope to people right across the country, particularly in New South Wales where they are fighting this Delta strain in the most significant battle we have had in this country during the course of the COVID-19 pandemic up until now'.

Despite COVID-19 having a 99.8% recovery rate with deaths occurring prior to vaccination only in the elderly and those with pre-existing illness, Mr Morrison said the newly secured doses are targeted to 20- to 39-year-olds.

Australia's Chief Medical Officer, Professor Paul Kelly (pictured left) and Prime Minister Scott Morrison (right) at a press conference in early August.

'(They) were identified in the Doherty modelling as peak transmitters of COVID-19,' he said.

'Some of those doses will be prioritised for express delivery to the 12 government areas where the COVID-19 outbreak continues to grow.

'This allocation is based directly on the advice I received from the Chief Medical Officer, Professor Kelly'.

Mr Kelly advised media in early August Sydney needed a 'circuit breaker' to drive COVID cases down to an unachievable zero, stating the lockdown was working to suppress the 'Delta' variant outbreak.

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