Arriving fashionably late, Novavax is finally ready to rock with its COVID-19 vaccine.
The first doses of the Nuvaxovid vaccine have departed a distribution site in The Netherlands, bound for Austria, France and Germany, the company said on Wednesday. Supplies to other countries in the European Union are soon to follow.
“The Novavax COVID-19 vaccine provides a differentiated option to bolster vaccination rates across Europe,” Stanley Erck, CEO of Novavax, said in a release.
Unlike the highly successful mRNA shots from Pfizer-BioNTech, Nuvaxovid is a protein-based jab, much like the traditional flu shots that have been around for decades.
Novavax has a deal to provide 100 million shots to the EU and the bloc has an option to order 100 million more. The shot has been authorized for adults in Europe. Novavax said it will file for EU approval in kids ages 12 to 17 this quarter.
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Getting shots delivered was a long time coming for the Gaithersburg, Md.-based company, which had never developed an approved vaccine.
After it was hailed as a rags-to-riches success for its rapid development of the vaccine, Novavax ran into a series of regulatory and manufacturing stumbles. The company originally projected its shot would be authorized and ready for delivery in the middle of last year.
Now, the company is piling up approvals around the globe, has solidified its production capabilities with its manufacturing partner the Serum Institute of India and is touting its ability to bring a differentiated shot to the market.
Novavax sees its shot filling a need as a primary series, a booster and as a pediatric answer. As a more traditional shot, the company believes it may be more accepted among vaccine holdouts. The shot also could be successful in middle- and low-income countries as it has less stringent cold-storage requirements.
“There’s an emerging body of evidence—not only from studies done by others but from our own that we seek to grow—that shows we can be used as a booster,” Sylvia Taylor, Novavax’s EVP of global corporate affairs and investor relations, told Fierce Pharma last month.
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Novavax’s shot is one of seven being evaluated in COV-Boost, a “mix-and-match” trial in the U.K. The vaccine is also part of Com-COV2, another trial exploring the mixing of COVID-19 vaccines and boosters.
Last month, Novavax filed for emergency approval of the vaccine in the U.S.
Analysts at Jefferies believe there's lots of opportunity for Novavax's shot to thrive.
"(It) has high efficacy/immunogenicity and clean safety/tolerability, as well as convenient logistics and a well-validated protein-based technology," analyst Roger Song wrote. "As a result, we believe it could play a meaningful role in the future COVID-19 vaccine market."