Another leading vaccine manufacturer is keen to provide doses to Australia, with Johnson & Johnson working “in close collaboration” with federal health authorities to get its candidate approved.
It comes as Novavax confirms it will use US and European manufacturers – rather than Australian companies – to produce the 51 million doses it has agreed to supply to Australia.
The national political spotlight has shone squarely on COVID vaccines in recent weeks, as further test results and details about Australia’s rollout are analysed.
The federal government has contracts for 10 million doses of the Pfizer vaccine, 54 million of the AstraZeneca and Oxford vaccine, and 51 million of Novavax.
But some public health experts have raised concerns over the efficacy of the AstraZeneca jab, which is between 62 and 90 per cent; Australian authorities are seeking more information on Pfizer after a small number of elderly Norwegians died after being vaccinated; and minor confusion erupted last week over whether the Novavax doses could be made onshore by Melbourne’s CSL.
Australia’s chief medical officer Professor Paul Kelly last week didn’t rule out further deals and said Australia was in talks with “a dozen” manufacturers.
One of those, he said, was American medical firm Johnson & Johnson, which had “applied for a provisional designation” with Australia’s Therapeutic Goods Administration.
“They’re going through the pathway for approval in Australia … But there were issues we were not able to agree on with Johnson & Johnson, which was mainly in their court,” Professor Kelly said, adding any deal was “off the table at the moment”.
But a spokesperson for Janssen, the pharmaceutical arm of Johnson & Johnson, appeared to signal the company was still open to dealing with Australia.
Janssen ‘in close collaboration’ with TGA
“The Therapeutic Goods Administration (TGA) has enabled a rolling review of the Janssen single-dose COVID-19 vaccine candidate,” a company spokesperson told The New Daily.
“Janssen continues to work in close collaboration with the TGA to complete the rolling review process and to facilitate provisional registration on the Australian Register of Therapeutic Goods when appropriate.”
Janssen said the company was “in active discussions with local and international health authorities, governments, regulators and NGOs” on its vaccine.
The Department of Health said the TGA was evaluating the vaccine, but signalled registration would be some way off, pending much more data.
“Janssen has submitted an application to the TGA for provisional registration of their COVID-19 vaccine. The application is currently under evaluation by the TGA,” a department spokesperson told TND.
“The TGA has agreed to accept rolling data to enable evaluation as information comes to hand, but will only be in a position to make a registration decision once the required data relating to safety, quality and efficacy has been provided and assessed.”
The TGA is expected to approve the Pfizer vaccine later this month and the AstraZeneca vaccine in February.
Consideration of Pfizer may be affected by the findings from Norway.
TND contacted federal Health Minister Greg Hunt for comment.
What is Johnson & Johnson’s vaccine?
The Janssen jab, known officially as JNJ-78436735, is different to many COVID vaccines in that it would likely be a single-dose treatment, unlike the Pfizer, AstraZeneca and Novavax candidates, which require two.
Phase 3 trials are still being carried out, with results due to be published in late January.
Results of phase 1/2a trials, published just last week, showed the Johnson & Johnson vaccine was “generally well tolerated across all study participants” and created COVID antibodies in all participants aged 18 to 55.
“These neutralising antibodies remained stable through Day 71, currently the latest timepoint available in this ongoing study, in all participants aged 18 to 55 years,” Johnson & Johnson said.
“Data on durability of immune responses in trial participants aged over 65 years will be available in late January and longer-term follow-up to one year is planned.”
The study, published in the New England Journal of Medicine, found the vaccine was “safe and immunogenic in both younger and older adults”.
The vaccine is also known by the name Ad26.COV2.S. It is classed as an adenoviral vaccine, of a similar type to the AstraZeneca model, which means it likely would be able to be stored and transported at standard refrigerator temperatures.
The Pfizer jab must be stored at below -70 degrees Celsius.
In other vaccine news, Novavax says it currently plans to supply its 51 million doses to Australia from manufacturing plants in the United States or Europe, rather than produce it locally.
“We do not currently have plans in place to manufacture our vaccine in Australia. We may consider this in the future,” a company spokesperson told TND.
It comes after a furore last week over a report that CSL could make the vaccine in Melbourne.
The company initially said it did not have the ability to manufacture Novavax and AstraZeneca’s vaccines at the same time, with the latter being its initial focus.
However, CSL later issued a second statement, saying it may consider its capabilities to make Novavax once the AstraZeneca production was complete.
Mr Hunt said the government never envisaged CSL would make both at the same time.
For its part, Novavax says it does not plan to manufacture in Australia, and was not in discussions with any other local manufacturers besides CSL.
Instead, its vaccines will be made in eight other countries around the world, and shipped internationally.
“We have had exploratory discussions with CSL, however CSL capacity was not able to meet our current needs,” the company said.
“Our current plan is to supply Australia from our network of ex-US manufacturing facilities with the majority of product expected to come from our European locations.”
Novavax expects it will begin manufacture in the second quarter of 2021.