CSL ‘optimistic’ on vaccine delivery as AstraZeneca provides data to regulators

CSL’s chief scientific officer Andrew Nash says Australia has a range of options in place when it comes to COVID vaccines even if the Oxford/AstraZeneca project were to hit regulatory hurdles.

The axing of the local University of Queensland vaccine candidate last Friday puts the ASX-listed biotech’s focus squarely on the Oxford/AstraZeneca vaccine, for which it has committed to make 50 million doses. While CSL has started the production process it must wait for AstraZeneca to secure regulatory approval of the product before it can be deployed.

CSL chief scientific officer Dr Andrew Nash said the government has done a good job at giving Australia multiple COVID vaccine options.
CSL chief scientific officer Dr Andrew Nash said the government has done a good job at giving Australia multiple COVID vaccine options. Credit:AAP

Dr Nash said CSL was “optimistic” that the product would work its way through approvals smoothly. When asked how Australia would be placed if AstraZeneca did end up facing hurdles to approval, he said the country was still well placed to secure other supply.

“The government has access to the Pfizer vaccine and we have the COVAX facility. Should the worst case scenario play out, the government has other options in place to access other vaccines,” he said.


“The regulatory process with the AstraZeneca vaccine is certainly in the hands of AstraZeneca and they have been engaging with the TGA throughout the process,” he added.

Over the weekend Health Minister Greg Hunt reiterated the government’s prediction that the Oxford vaccine could be approved in Australia as soon as January.

A spokeswoman for AstraZeneca Australia did not comment on the company’s expectations on when the product would be approved, however, explaining the business was “continuing to provide data packages as they become available, in parallel with submission to other regulatory authorities elsewhere in the world”.

“As an independent regulator focused on ensuring that safe and effective medicines and vaccines reach the Australian community, we acknowledge the rigorous and extensive review the TGA takes of available data,” she said.

CSL shares lost 3.2 per cent on Friday after news the UQ vaccine project had been shelved after trial participants recorded false positives on HIV tests. The biotech giant opened down a further one per cent in the first hour of trading on Monday.

CSL’s involvement in onshore manufacturing of the Pfizer vaccine is likely to be limited. While the company said on Friday it was open to requests from government to work on other projects, Dr Nash said no conversations had been started about involvement with other candidates.

“Not in terms of the other COVID vaccines,” he said.

Australia is expecting doses of the vaccine made by Pfizer and BioNTech to land onshore next year, though CSL has largely ruled out the prospect of making that product under licence in Australia.

Senior vice president of research at CSL’s vaccine arm Seqirus, Dr Russell Basser, said on Friday that the task of upgrading the company’s facilities to make it ready for producing the Pfizer vaccine would be a significant challenge.

“I would judge there is a very low likelihood we would be able to do this in any timeframe that would relevant to the pandemic,” he said.

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Source: Thanks smh.com