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Vaccine developers and may face major hurdles in getting their experimental COVID-19 vaccine to market, despite recently being touted as winners of the COVID-19 vaccine race.

The firms have achieved impressive results in clinical trials 鈥� with their jointly developed 鈥楤NT162b2鈥� vaccine showing more than 95% efficacy 鈥� and have since been granted provisional determination by the (TGA).

However, it is still unknown how long their mRNA-based vaccine will give protection against COVID-19, or whether certain participants may be resistant to it. As such, the TGA could still pull the plug on Pfizer and BioNTech鈥檚 rolling submission, forcing them to go back to the drawing board with their vaccine design.

鈥淏efore any COVID-19 vaccine is approved for use in Australia, it will be subject to the TGA鈥檚 stringent assessment and approval processes, after being tested in large clinical trials of over ten thousand people,鈥� a TGA spokesperson said.

鈥淭he initial data that the TGA has received from Pfizer have been very promising. [It] already has the data on what the vaccine does in some animals, data on its manufacturing and analyses, but not the full set of clinical or manufacturing data.

鈥淭he TGA is likely to receive further data in the next few months and a decision will be made soon after following the assessment of all the required data to ensure the vaccine is of suitable quality, efficacious and safe.鈥�

If TGA approval is granted, it could still take some time before the Pfizer and BioNTech vaccine becomes available for mainstream usage in Australia.

Currently Australia does not have infrastructure to manufacture mRNA-based vaccines domestically, meaning import dependency is likely. This could put pressure on supply chains 鈥� especially as the vaccine must be stored at very low temperatures during transportation.

However, Pfizer said the firm was confident in its ability to manufacture and distribute the vaccine at scale.

鈥淥ur track record gives us confidence in our ability to quickly scale,鈥痬anufacture and distribute large quantities of a high-quality COVID-19 vaccine, leveraging multiple sites in the US and Europe [鈥�],鈥� said a spokesperson.

鈥淲e have developed detailed logistical plans and tools to support effective vaccine transport, storage and continuous temperature monitoring [鈥�].

鈥淲e have also developed packaging and storage innovations to be fit for purpose [including] specially designed, temperature-controlled thermal shippers (ie, frozen boxes), utilising dry ice to maintain recommended storage conditions [鈥�].鈥�

Meanwhile, the TGA said that COVID-19 vaccine applications are being treated with the greatest priority as part of the Department of Health鈥檚 response to the pandemic.

鈥淭he first vaccines are likely to be available early in the first quarter of 2021, subject to clinical approvals, as well as data and regulatory approvals,鈥� it said.

Image credit: 漏stock.adobe.com/au/pickup