Delivery of Novavax vaccine may be delayed in Australia due to reported manufacturing issues

Australians may not get access to the Novavax vaccine this year with reports of manufacturing problems causing more delays.

Australians waiting for the Novavax vaccine may not get access to the jab this year due to reports of more manufacturing problems that have seen stock prices for the American drugmaker plummet.

Australia has ordered 51 million doses of the long-awaited Novavax vaccine, which was expected to play a large role in the booster program, and was expected to begin delivery this year.

But according to a report in Politico that cites anonymous sources, issues with its manufacturing process may be more concerning than previously understood.

The company has reportedly struggled to meet the US Food and Drug Administration’s quality standards, with purity levels for its vaccine batches hovering around 70 per cent, rather than the required 90 per cent.

Lower purity levels increase the chance that contaminants or unnecessary substances could make the vaccines less effective or cause a reaction in patients.

Publication of the report saw Novavax stocks plunge by up to 26 per cent on Wednesday (US time) before ending the day 14 per cent down, The Wall Street Journal reported.

Medical lab scientists work on samples collected in the Novavax Phase III Covid-19 clinical vaccine trial at the UW Medicine Retrovirology Lab in Seattle, Washington. Picture: Karen Ducey/Getty Images/AFP

Novavax released a statement saying, “Novavax confirms our confidence in our ability to deliver our high-quality vaccine.

“Further, we underscore our ongoing commitment to the stringent standards of production and manufacturing.”

Novavax said it expected to achieve a capacity of 150 million doses per month by the end of the fourth quarter (typically at the end of the year for American companies).

“We are confident that our vaccine will soon play a significant role in the global Covid-19 vaccine arsenal, differentiated by its potential to help address two major issues slowing the world’s ability to end the pandemic: global distribution challenges and vaccine hesitancy,” Novavax president Stanley C. Erck said.

Complicated manufacturing process

Deakin University epidemiologist Professor Catherine Bennett told news.com.au challenges with Novavax were known early on due to its more complicated manufacturing process.

Novavax is different from other vaccines currently available in Australia as it relies on a spike protein being produced in a laboratory.

The mRNA vaccines, Pfizer and Moderna, instead stimulate our bodies to produce the spike protein ourselves.

Prof Bennett said Novavax builds the protein using lab-grown insect cells. This requires more ingredients and likely throws up more challenges to things like purity, especially when you are trying to manufacture lots of doses.

“It just shows that getting to market (with a vaccine) is a combination of many things … and trying to do it at scale is a challenge the more complex the vaccine is,” she said.

“It’s very disappointing because this was a very promising vaccine.”

Novavax uses lab-grown insect cells to produce a spike protein for its vaccine. Picture: Justin Tallis/AFP

Australian authorities still waiting on Novavax data

Novavax was initially due to arrive in Australia in the middle of the year but this was pushed back due to manufacturing delays.

As recently as September, Novavax told The New Daily it was ready to begin shipping vaccines to Australia as soon as it got approval from the Federal Government. The safety of the vaccine is being assessed by the Therapeutic Goods Administration (TGA).

In its statement, Novavax said it expected to complete regulatory submissions within the next couple of weeks in key markets, including in Australia, the United Kingdom, Europe, Canada and New Zealand.

Australian authorities indicate they are still waiting on data from the company.

A spokeswoman for Australia’s Department of Health noted Novavax had not yet received regulatory approval in any country but said the TGA was ready to proceed with the application “as soon as the required data are supplied”.

She said initial data was received in February 2021.

“This is a rolling review, whereby the sponsor supplies the TGA with data as it comes to hand,” she said.

“The TGA can only make a regulatory decision on the Novavax vaccine once the complete data package has been provided by the sponsor to enable the required regulatory processes. “Therefore, it is not possible to speculate on timeframes at this stage.”

Once the TGA assesses the vaccine as safe and effective, she said doses could begin to arrive in Australia “as early as this year”.

‘Some people are waiting for Novavax’

Prof Bennett said Novavax would have provided individuals who were vaccine hesitant with a different type of jab.

It could also be good for those who had experienced a bad reaction to one of the other vaccines, and would have given the TGA another option to consider when looking at what combinations of vaccines worked well together.

“It’s always good to have more choice,” Prof Bennett said.

But she didn’t think a delay in getting doses would impact Australia’s vaccine rollout “except at the margins”.

“Some people are waiting for (Novavax) or want to get it as their second dose,” she said.

“But most people are getting vaccinated because the virus is here.”

Australia recently hit a 70 per cent vaccination target for adults and while the 51 million doses of Novavax were expected to play a role in the country’s booster program, it does have other vaccines available, including Pfizer and Moderna, to finish its initial rollout.

Health authorities have also previously warned people against waiting for particular vaccines as those who have not been vaccinated are more likely to die of Covid-19.

The more serious consequence may be for the delivery of vaccines worldwide.

Novavax previously pledged to deliver 1.1 billion doses to Covid-19 Vaccines Global Access (COVAX) aimed at ensuring equitable access to vaccines.

It comes as experts warn a Covid-19 mutation resistant to vaccines could emerge within a year if authorities around the world – including Australia – don’t take action to make sure vaccines are available to every country around the world by the end of next year.