After overcoming a number of manufacturing hurdles Novavax says its long-awaited COVID-19 vaccine is lastly prepared for mass distribution. Amid a flurry of purposes being filed with regulatory companies the world over, Indonesia has grow to be the primary nation to formally grant emergency use authorization for the vaccine, and the corporate hopes to file with the US Meals and Drug Administration (FDA) by the top of the yr.
Within the early days of the pandemic Novavax’s COVID-19 vaccine was positioned as one of the vital promising vaccines in growth. In July 2020 the corporate was awarded US$1.6 billion from the US authorities as a part of Operation Warp Pace. However as time handed, and different COVID-19 vaccines had been efficiently administered to tons of of thousands and thousands of individuals, Novavax’s candidate slipped into the background.
Novavax’s COVID-19 vaccine was by no means going to be the primary out of the gate. It is named a protein subunit vaccine, and this expertise takes a bit extra time to develop.
Not like mRNA vaccines, which job our personal cells with producing the coronavirus spike protein, serving to the immune system study to focus on SARS-CoV-2, protein subunit vaccines develop these spike proteins individually in a lab. These proteins are then mixed with nanoparticles and formed right into a construction designed to resemble that of the coronavirus.
By early 2021 preliminary indicators from scientific trials had been indicating Novavax’s vaccine was extremely protected and efficient. However one other main hurdle was looming – large-scale manufacturing.
Protein subunit vaccines should not new. A number of profitable vaccines have been deployed utilizing the expertise, together with hepatitis B and pertussis vaccines. Nonetheless, mass manufacturing these vaccines is difficult, and as 2021 progressed it turned clear Novavax was having hassle scaling up manufacturing to provide the billions of doses wanted.
From key ingredient provide issues to inconsistent purity ranges within the last product, the final yr has seen Novavax encounter a myriad of challenges in its quest to mass produce a protein subunit COVID-19 vaccine. Now, on the finish of 2021, the corporate says it’s prepared to provide 150 million doses per thirty days, with a sturdy world provide chain manufacturing the vaccine throughout a lot of websites all over the world.
In August the corporate indicated it will prioritize regulatory submissions in international locations with pressing wants. Indonesia just lately turned the primary nation on the earth to grant emergency use authorization to Novavax’s vaccine and its provide will come from the Serum Institute of India. Authorizations are anticipated to quickly comply with in India and the Philippines.
“The primary authorization of Novavax’ COVID-19 vaccine exemplifies our dedication to equitable world entry and can fill an important want for Indonesia, which regardless of being the fourth most populous nation on earth, continues to work to obtain ample vaccine for its inhabitants,” mentioned Novavax CEO Stanley Erck, in a assertion printed on the first of November.
Alongside these looming approvals, Novavax has just lately filed regulatory submissions with authorities within the European Union, Australia, Canada, New Zealand and the UK. An emergency use itemizing has additionally been filed with the World Well being Group (WHO). This WHO authorization is important earlier than Novavax can start distributing the multiple billion doses promised as a part of its COVAX settlement meant to make sure equitable vaccine entry to low- and middle-income international locations.
Novavax’s vaccine will undoubtedly play a basic function in getting vaccination charges up the world over, as inequity in vaccine distribution turns into an more and more outstanding drawback. The Novavax vaccine may be saved in customary fridge temperatures, making it extremely helpful in international locations with out the advanced super-cold chain provide strains wanted for mRNA vaccines.
Nonetheless, it’s but to be seen how mandatory the vaccine can be in locations with already excessive vaccination charges. Novavax has prompt its vaccine might play an enormous function in future booster packages, and trials are ongoing testing it as a booster following two-dose protocols with different COVID-19 vaccines.
And, by way of entry in the US, the corporate appears to be in no rush to file emergency authorization with the FDA. Regardless of current regulatory filings with extremely vaccinated international locations similar to Australia and New Zealand, Novavax has but to file any submission with the FDA. A whole submission to the FDA is predicted over the subsequent few weeks, or by the top of 2021 on the newest.