Novavax booster doses to soon join stockpile

Novavax will complete its application for approval for its Covid-19 vaccine in Australia ‘within weeks’ of making a similar application to regulators in Britain next month.

Australia has ordered 51 million doses of the Novavax vaccine, which is expected to be used as a booster next year. Picture: AFP

Novavax will complete its application for approval for its Covid-19 vaccine in Australia “within weeks” of making a similar application to regulators in Britain next month.

Although the company confirmed it will begin shipping doses to select countries by the end of this month, the vaccine is not expected to begin arriving in Australia until after October, later than expected due to manufacturing delays.

The company has again ­delayed its application to the Food and Drug Administration for approval of its vaccine, with doses not expected to be supplied to the US until the end of the year.

But it has progressed with its first applications to regulators in India, Indonesia and The Philippines, and will begin shipping the first 100 million doses of its protein-based vaccine to those countries at the end of this month.

Novavax expects to increase production to 150 million doses a month by the end of the year, and some of those doses will be shipped to Australia.

“Initially, our doses may be prioritised to low-income countries, where we’ll be able to support critical unmet demand for primary vaccinations,” Novavax chief executive Stanley Erck said during a quarterly investor call.

Plans for the first shipments of the Novavax vaccine come after months of manufacturing delays when the company was unable to source special plastic bags used in the manufacturing process.

The TGA granted a provisional determination for the Novavax vaccine in January, and the company has been providing clinical and non-clinical data to the regulator since then to assist the approval process.

Australia has ordered 51 million doses of the Novavax vaccine, which may be used as a primary vaccine and/or booster.

It adds to Australia’s supplies of 40 million initial doses of Pfizer, 50 million doses of AstraZeneca that are being manufactured onshore, and 25 million doses of Moderna. Australia has also ordered an extra 85 million doses of Pfizer, to be supplied next year as boosters.

Australia has administered 13,270,296 doses of vaccine, with 21.38 per cent of the population fully vaccinated.

Mr Erck said his company was on track to submit a regulatory ­filing in Britain next month followed “within weeks” by submissions in Australia and Canada.

News of the upcoming application to the Therapeutic Goods Administration came as results of a clinical trial were announced, showing that when ­administered as a booster six months after an initial two-dose regimen of the same vaccine, the Novavax vaccine, known as NVX-CoV2373, increased neutralising antibodies to SARS-CoV-2 fourfold.
 For the Delta variant, there was a six-fold increase in cross-reactive functional antibodies compared to primary vaccines.

“The strong results from this study reinforce our confidence in the potential for a booster dose of NVX-CoV2373 to provide broad protection against disease, including from known and emerging variants,” said Novavax’s research and development president, Gregory Glenn.

“Given the evidence that natural and vaccine-induced immunity wanes over time, the continuation of our proactive clinical development program will be critical to understanding and demonstrating the effectiveness of our recombinant nanoparticle COVID-19 vaccine,” he said.

In addition to Novavax’s booster study, it vaccine is one of seven COVID-19 vaccines being evaluated as part of COV-Boost, a “mix-and-match” study being conducted in Britain by the University Hospital Southampton NHS Foundation Trust and other research sites.

COV-Boost is evaluating the effect on antibody production of boosting with a different vaccine to the one originally administered.