Novavax: The “Covid Gap” miracle in Australia failed as doses to be disposed of

Novavax: The “Covid Gap” miracle in Australia failed as doses to be disposed of

In the early days of the pandemic, it was hailed as a solution to Australia’s delayed immunization rate, and a knock-out that would defeat the “hesitating vaccine”.

But of the 51 million doses of Novavax purchased by the Commonwealth and 13.3 million doses delivered, only 218,000 were given – leaving millions for the container as its expiration date approaches.

Executives have attributed the low uptake of Covid-19 vaccines in Australia to what they say is a “bad policy decision” by the federal government and its panel of immunization experts.

Novavax claims that its protein-based vaccine has not been discussed or offered in Australia’s immunization strategy or is being actively offered “through various channels”.

The company’s chief medical officer Philip Dubowski and chief business officer John Trezzino also criticized ATAGI’s decision not to recommend their vaccine as the first choice for booster doses.

“I think there is definitely a direct link from this decision to use the vaccine,” Trezzino said.

“There is very little we can do as a company to get around what we think is a bad political decision.”

The Australian Technical Advisory Group on Immunization has recommended Novavax as a booster only for people who cannot or do not want to have one of the Pfizer or mRNA vaccines, which it says are “preferred”.

Novavax has made multiple appeals to ATAGI to reconsider its advice, with Mr Trizzino saying they “certainly have a right to their say” but that “data and science are in our best interest”.

“I think it is fair to describe that we were disappointed in the first recommendation (ATAGI) based on the data that was presented to them,” Mr. Trizzino said.

“Now we are keen to make a complementary offer in order to reverse the decision.”

Mr Trizzino said Novavax’s problem with ATAGI’s advice – which hasn’t changed yet and may not – was “the water under the bridge”.

Asked if he wanted to make ATAGI’s decision-making process more transparent, Mr Trizzino said: “Different countries approach this in different ways.”

Pressing new data that Novavax will have to provide to ATAGI, Dr Dubowski said there was a “growing body of evidence” from the US government, the UK government, academics in Asia and other partners that showed its vaccine was an effective booster for people who had already been vaccinated with types of vaccines. other vaccines.

A spokesperson for the Department of Health confirmed Friday that it was planning another meeting between ATAGI and Novavax “to examine the most recent evidence and data available.”

Dr Dubowski and Mr Trezzino spent the week lobbying politicians in Canberra to give Novavax a greater say in its long-term immunization strategy, and they met Health Minister Mark Butler on Wednesday.

Butler declined to comment, and forwarded questions put to him to the Department of Health.

The Morrison government once considered getting the Novavax vaccines to be a top priority in what would become its long mission to vaccinate Australians against Covid-19.

Novavax was thought to be a good choice for the “vaccine hesitant” who, for whatever reason, stayed away from the Pfizer, Moderna and AstraZeneca shots and said they were “waiting for Novavax.”

But only 120,000 Novavax vaccines have been given as initial doses, with 98,000 given as a third or fourth booster dose.

so what happened?

Novavax’s Covid-19 shots became the first vaccine the company had successfully brought to market in its 34-year history.

By mid-2021, the Novavax vaccine had shown encouraging results in clinical trials, but failed to provide the National Drug Regulatory Authority with sufficient information to approve its use, delaying its entry into Australia.

The Morrison government backed away from its commitment to using Novavax as the primary vaccine because it was focused on getting Pfizer shots, which were in short supply and high in demand.

At the time, Novavax was not approved anywhere in the world. The company says its vaccine is now used in more than 40 countries.

By the time the Therapeutic Goods Administration approved Novavax as the initial course of vaccination for adults on January 20, 93 percent of people over 16 had already received two doses of the Covid vaccine.

TGA’s Jon Skerrit said at the time that even if only 2 percent of those seven percent were interested in taking Novavax, we would “continue our journey toward mastering Covid in this country.”

“I don’t know if it’s 50,000 or 100,000 or a million or any individuals (who will apply for vaccination), I don’t think anyone knows but there are some individuals, and that just gives them more options,” he said.

Julie Lisk, a vaccine expert at the University of Sydney, says people who are reluctant to get the vaccine can be deterred by the fact that Novavax is not easily accessible and one might “really need to shop” to get it.

But Prof Leask endorsed ATAGI’s advice, saying its recommendations are carefully considered and “evidence-based and pragmatic”.

“If ATAGI doesn’t have enough evidence that the heterogeneous (mixing different types of vaccines) booster with Novavax is effective, it will fall back somewhat,” she said.

Prof Leask said some people have misinterpreted ATAGI’s advice to think they need a letter from a doctor in order to receive Novavax.

“If advice is interpreted in these different ways, it is up to governments to ensure that the mediation between advice and implementation is done as clearly as possible,” she said.

Novavax’s Australian sponsor, Biocelect, estimates that only one in four providers is running Novavax, due in part to concerns about waste and confusion over ATAGI advice.

The Sydney-based Small Pharma Marketing Corporation supplies the vaccine to the Commonwealth, which then distributes it to government clinics, GPs and pharmacies.

“We feel that it may be easier for ATAGI to issue new advice than to provide us with information for each provider,” said Biocelect co-founder Jennifer Herz.

Novavax noted that they have some new data. We hope this will be reviewed as soon as possible.”

Australian Medical Association Vice President Danielle McMullen said Novavax was not expected to be less involved in the country’s release of the vaccine, given that AstraZeneca and Pfizer were subsequently marketed.

“It’s a valuable option for people, especially if people have had an adverse reaction to other vaccines, but it is not at all surprising that much smaller numbers are being used,” said Dr. McMullen.

Virologist and vaccine expert at the University of Sydney, Tony Cunningham, said it was difficult for him to comment on what ATAGI was saying.

“I think there are published studies showing that mRNA vaccines are better than Novavax at boosting, but I’ve recently seen data that says Novavax is very good, and I don’t think the data has been published yet,” he said.

Doherty Institute immunologist Dale Godfrey said he thought Novavax was as good a contender for the booster shot as any of the other shots, but acknowledged that there was less information available about how well it worked.

“There’s some data that I’ve seen that suggests Novavax looks very cool as a booster,” he said.

“I definitely don’t think people avoid it because it’s inferior. I think there’s a little bit of vaccine fatigue.”

Paul Griffin, director of infectious diseases at Mater Hospital in Brisbane, said he personally disagreed with ATAGI’s advice on Novavax, especially since absorption of the booster was “quite behind where it should be”.

Dr. Griffin acknowledged he was “very involved” in developing the Novavax vaccine as the principal investigator for the early clinical trials in Australia.

He said he appreciates that ATAGI has had a challenging time during the pandemic but believes it would be beneficial if there was greater transparency about the rationale for its decisions.

A spokesperson for the Ministry of Health said ATAGI’s recommendations were based on a comprehensive study and review of all available domestic and international evidence.

“Their deliberations take into account the data submitted through the TGA’s interim approval process along with all available domestic and international data,” he said.

“Novavax will continue to play an important role in protecting the Australian community from severe illness or death associated with Covid-19 infection.”

While the Commonwealth government says it has invested more than $8 billion in rolling out a Covid-19 vaccine, the amount it has spent on each vaccine is included in a confidential purchase agreement with manufacturers.

Health Secretary Mark Butler announced on June 30 a “rapid” investigation into deals to supply Covid-19 vaccines issued by the Morrison government.

Former Health Secretary Jane Halton was asked to lead the review, examining why Australia was in short supply at the height of the pandemic and how purchases compare internationally.

“There is no strict deadline for completing this review, but it is clearly something we want to do in weeks, not months,” Butler said at the time.

It is understood that the Albanian government is awaiting the final report of the inquiry.

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