After overcoming several manufacturing hurdles Novavax says its long-awaited COVID-19 vaccine is finally ready for mass distribution. Amid a flurry of applications being filed with regulatory agencies across the world, Indonesia has become the first country to formally grant emergency use authorization for the vaccine, and the company hopes to file with the US Food and Drug Administration (FDA) by the end of the year.
In the early days of the pandemic Novavax’s COVID-19 vaccine was positioned as one of the most promising vaccines in development. In July 2020 the company was awarded US$1.6 billion from the US government as part of Operation Warp Speed. But as time passed, and other COVID-19 vaccines were successfully administered to hundreds of millions of people, Novavax’s candidate slipped into the background.
Novavax’s COVID-19 vaccine was never going to be the first out of the gate. It is known as a protein subunit vaccine, and this technology takes a bit more time to develop.
Unlike mRNA vaccines, which task our own cells with producing the coronavirus spike protein, helping the immune system learn to target SARS-CoV-2, protein subunit vaccines grow those spike proteins separately in a lab. Those proteins are then combined with nanoparticles and shaped into a structure designed to resemble that of the coronavirus.
By early 2021 preliminary signs from clinical trials were indicating Novavax’s vaccine was incredibly safe and effective. But another major hurdle was looming – large-scale manufacturing.
Protein subunit vaccines are not new. Several successful vaccines have been deployed using the technology, including hepatitis B and pertussis vaccines. However, mass manufacturing these vaccines is challenging, and as 2021 progressed it became clear Novavax was having trouble scaling up production to produce the billions of doses needed.
From key ingredient supply problems to inconsistent purity levels in the final product, the last year has seen Novavax encounter a myriad of challenges in its quest to mass produce a protein subunit COVID-19 vaccine. Now, at the end of 2021, the company says it is ready to produce 150 million doses per month, with a robust global supply chain manufacturing the vaccine across a number of sites around the world.
In August the company indicated it would prioritize regulatory submissions in countries with urgent needs. Indonesia recently became the first country in the world to grant emergency use authorization to Novavax’s vaccine and its supply will come from the Serum Institute of India. Authorizations are expected to soon follow in India and the Philippines.
"The first authorization of Novavax' COVID-19 vaccine exemplifies our commitment to equitable global access and will fill a vital need for Indonesia, which despite being the fourth most populous nation on earth, continues to work to procure sufficient vaccine for its population," said Novavax CEO Stanley Erck, in a statement published on the 1st of November.
Alongside those looming approvals, Novavax has recently filed regulatory submissions with authorities in the European Union, Australia, Canada, New Zealand and the United Kingdom. An emergency use listing has also been filed with the World Health Organization (WHO). This WHO authorization is necessary before Novavax can begin distributing the more than one billion doses promised as part of its COVAX agreement intended to ensure equitable vaccine access to low- and middle-income countries.
Novavax’s vaccine will undoubtedly play a fundamental role in getting vaccination rates up across the world, as inequity in vaccine distribution becomes an increasingly prominent problem. The Novavax vaccine can be stored in standard refrigerator temperatures, making it highly useful in countries without the complex super-cold chain supply lines needed for mRNA vaccines.
However, it is yet to be seen how necessary the vaccine will be in places with already high vaccination rates. Novavax has suggested its vaccine could play a big role in future booster programs, and trials are ongoing testing it as a booster following two-dose protocols with other COVID-19 vaccines.
And, in terms of access in the United States, the company seems to be in no rush to file emergency authorization with the FDA. Despite recent regulatory filings with highly vaccinated countries such as Australia and New Zealand, Novavax has yet to file any submission with the FDA. A complete submission to the FDA is expected over the next few weeks, or by the end of 2021 at the latest.
