Made in Melbourne: lab to start producing promising coronavirus vaccine

08 / 11 / 2020

By The Sydney Morning Herald - -

Global biotech company CSL will begin manufacturing millions of vials of one of the most promising coronavirus vaccines in Melbourne, in the hope trials will prove it is effective and can be rapidly distributed.

CSL chief scientific officer Andrew Nash said one-millilitre vials of the University of Oxford-AstraZeneca COVID-19 vaccine will be thawed on Monday, having been frozen in liquid nitrogen to preserve their integrity.

The thawed vaccine, which came from a cell bank, will be added to a bioreactor – a large vessel where biological reactions take place – where it will go through a fermentation process, grow and multiply. This facility at Broadmeadows is the only one of its kind in Australia, Dr Nash said.

The vaccine will spend six days multiplying in the bioreactor, then be filtered and purified, leaving just the antigen – or vaccine product – ready to be put into dosage vials. There will be eight or nine processes like this, each producing 3 million to 4 million doses.

“We’re making it ahead of time so that should the clinical trial be positive, with the outcomes that we’re looking for, the vaccine will be available … to distribute to the population,” Dr Nash said.

The biotec company has separate contracts with AstraZeneca and the Australian government to manufacture about 30 million doses of this vaccine candidate.

CSL said the total processing time for the vaccine is approximately 50 days. The vaccine is still subject to approval by the Therapeutic Goods Administration for use in Australia.

The results of stage three clinical trials on the vaccine are expected by the end of this year. If they are positive and the vaccine passes all regulatory requirements, the first doses could be released in the first half of next year.

There are more than 150 candidate COVID-19 vaccines, most of which are in pre-clinical stages, meaning they are still being tested on animals or in labs. About 40 have reached human trials.

CSL is manufacturing two separate vaccines, the Oxford-AstraZeneca vaccine and the University of Queensland vaccine. These will be done at separate times.

In animal studies, both the Oxford vaccine that Australia purchased and the University of Queensland’s vaccine effectively stopped SARS-CoV-2 getting deep into the lungs.

“From the phase one studies we have seen the [Oxford/AstraZeneca] vaccine is safe, which is the really critical thing, so we’re not doing any harm,” Dr Nash said.

“We’ve seen that the vaccine can induce the immune response we would hope to see. Then we have to test in large numbers of people to see if that immune response prevents them from being infected. You can rest assured that it’s going to be safe. The question is whether it’s going to be effective.”