Biotechnology giant CSL is now firmly focused on producing the University of Oxford’s coronavirus vaccine in Australia after shelving the UQ vaccine project, while the company says it is unlikely to be able to quickly tool up facilities to make Pfizer’s vaccine onshore.
As reported by this masthead on Friday, a billion-dollar deal made by the Morrison government for 51 million doses of the UQ vaccine has been abruptly terminated and CSL will abandon further clinical trials of the product, known as v451.
In a statement to the ASX this morning, the $137 billion blood plasma giant said that while the vaccine candidate was safe, data from the phase 1 study led to the conclusion that “significant changes would be needed to HIV testing procedures in the healthcare setting to accommodate the rollout of this vaccine.”
The University of Queensland commenced its phase 1 study of the vaccine, using what is known as “molecular clamp” technology, in July.
Phase 1 trial data showed that some participants showed antibodies after vaccination which interfered with certain HIV diagnostic assays. “It was found these molecular clamp antibodies did cause a false positive on a range of HIV assays,” CSL said.
The company emphasised this possibility had been anticipated prior to the commencement of the trial. There was no potential for the vaccine to actually cause HIV infection and the participants returning false positives did not actually have the infection.
The decision to shelve the UQ project will leave CSL to focus on production of the AstraZeneca and University of Oxford vaccine candidate, which has not yet passed regulatory approvals.
The company was slated to make 30 million doses of the product and this will be increased by 20 million doses in light of the UQ news.
Senior vice president of research and development at CSL’s vaccine arm Seqirus, Dr Russell Basser, said it was unlikely other leading candidates, like Pfizer’s mRNA vaccine, could be made here because the company’s facilities are not currently equipped to do so.
“The mRNA process is very very different to the way we make recombinant proteins, which is the basis of the AstraZeneca and UQ vaccines. It would require significant adjustments of our factories to be able to do this,” he said.
“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.”
CSL said this morning the decision had been made to abandon further trials because of the “significant” issues the situation presents for community rollout.
“With advice from experts, CSL and UQ have worked through the implications that this issue presents to rolling out the vaccine to the broader population.
“This outcome highlights the risk of failure associated with early vaccine development,” CSL chief scientific officer Andrew Nash said.
In September, a deal was inked between CSL, UQ and the federal government for the production of 51 million doses of the product from CSL’s Melbourne production facilities, had the project been successful.
It was the largest deal by dose number that the government purchased, though CSL was keen to repeatedly caution that research projects were challenging and there was no complete assurance that the UQ vaccine would be successful.
Back in August, chief executive Paul Perreault told this masthead Australians should be “prepared for just about anything” when it comes to vaccine development.
“I would say the general population, just like those of us on the research and development side, should be prepared for pretty much anything at this point. It could be one shot, or a series of two shots — that’s yet to be determined.”
CSL slipped 2.4% to $294.09 in early trade on Friday.
Source: Thanks smh.com