Novavax arrives fashionably late and is finally ready to rock with its COVID-19 vaccine.
The first doses of the Nuvaxovid vaccine have left a distribution site in the Netherlands, heading for Austria, France and Germany. said on Wednesday. Deliveries to other EU countries will soon follow.
“The Novavax COVID-19 vaccine provides a differentiated opportunity to boost vaccination rates across Europe,” said Stanley Erck, Novavax’s CEO, in a statement.
Unlike the very successful mRNA shots from Pfizer-BioNTech, Nuvaxovid is a protein-based jab, just like the traditional flu shots that have been around for decades.
Novavax has an agreement to supply 100 million shots to the EU, and the bloc has an option to order 100 million more. The shot is approved for adults in Europe. Novavax said it will apply for EU approval in children aged 12 to 17 this quarter.
It took a long time to get shots delivered for the Gaithersburg, MD-based company that had never developed an approved vaccine.
After being hailed as a rag-to-wealth success for its rapid development of the vaccine, Novavax ran into a series of regulatory and manufacturing problems. The company initially expected its shots to be approved and ready for delivery by the middle of last year.
Now the company is gathering approvals across the globe, has strengthened its production capabilities with its production partner, the Serum Institute of India, and is highlighting its ability to bring a differentiated shot to market.
Novavax sees its shot fill a need as a primary series, a booster and as a pediatric response. As a more traditional shot, the company believes it may be more accepted among vaccine holdouts. The shot can also be a success in middle- and low-income countries, as it has less stringent requirements for cold storage.
“There is a growing body of evidence – not just from studies done by others, but from our own that we seek to grow – that shows we can be used as a booster,” said Sylvia Taylor, Novavax’s Global Corporate Affairs and Investor Relations EVP. , told Fierce Pharma last month.
Novavax’s shot is one of seven being evaluated in COV-Boost, a “mix-and-match” trial in the UK. The vaccine is also part of Com-COV2, another trial examining the mix of COVID-19 vaccines and boosters.
Last month, Novavax applied for emergency approval of the vaccine in the United States
Analysts at Jefferies believe there are plenty of opportunities for Novavax’s shots to thrive.
“(It) has high efficiency / immunogenicity and pure safety / tolerability, as well as convenient logistics and a well-validated protein-based technology,” wrote analyst Roger Song. “As a result, we believe it can play a meaningful role in the future COVID-19 vaccine market.”