Could 2022 be the year of the Novavax vaccine? Since the COVID-19 pandemic’s early days, the Gaithersburg, Maryland-based biotech has been plugging away on its shot, turning out impressive data but struggling to keep up with its own deadlines. Now, with emergency nods building across the globe, Novavax is plotting a course for its protein-based prophylactic in pandemic Year 3.
In the global market, Novavax expects demand to play out across all three key areas, Silvia Taylor, senior vice president, global corporate affairs and investor relations at Novavax, said in an interview on the sidelines of the J.P. Morgan Healthcare Conference. These include primary vaccination to unvaccinated people, booster doses—especially critical in the age of virus variants—and the pediatric market.
Weighing that trinity of primary, booster and pediatric need, there are some 5 billion “doses of demand” in the high-income market alone, Taylor said. Moving into middle- and lower-income countries, many of which still have low vaccination rates, demand jumps to more than 6.5 billion doses, she said.
The company’s protein-based vaccine ran up against a series of regulatory delays in 2021, but it’s charted some notable wins in recent weeks. Last month, NVX-CoV2373 nabbed a World Health Organization emergency use listing. Less than a week after the WHO nod, the European Medicines Agency recommended conditional marketing authorization for the shot.
And on New Year’s Eve, Novavax said it completed certain submissions required to fulfill the prerequisites for an EUA application request to the FDA. The company plans to submit its official EUA application request within a month from Dec. 31.
Now, as it anticipates gaining more authorizations, Novavax is banking on its vaccine’s strong efficacy profile, logistical perks and dependance on a more familiar vaccine platform to set itself apart from the rest of the pack, Taylor said. Data from the phase 3 Prevent-19 trial show the vaccine is 90.4% effective overall and offers 100% protection against moderate and severe disease. The vaccine doesn’t need to be frozen like Pfizer and Moderna’s mRNA-based shots, which adds the “ability to store and distribute using existing vaccine supply channels,” Taylor said. That’s important not just for the developing world but also in rural regions of higher-income countries or essentially areas where healthcare infrastructure might be less robust.
When it comes to kids, Novavax is testing its shot in adolescents ages 12 to 17, but the goal is to eventually cover “the full gamut of kids,” Taylor said, adding that the company hopes to move into studies in children as young as six months of age. The company plans to submit its initial pediatric filing in adolescents in the first quarter, the executive said.
On the booster front, Taylor noted, Novavax's shot could be used for both homologous boosting, when a person gets an additional dose of the same vaccine they started with, or heterologous boosting, when a person receives one vaccine to start and gets boosted with another.
“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,” Taylor said. Novavax’s shot is one of seven being evaluated in COV-Boost, a “mix-and-match” trial in the U.K., which is evaluating heterologous boosting. The vaccine is also part of Com-COV2, another trial exploring a heterologous regimen of COVID-19 vaccines.
COV-Boost, led by the University Hospital Southhampton NHS Foundation Trust, has shown that Novavax's shot works well as a booster following primary vaccination with mRNA or viral vector vaccines, a Novavax spokesperson added over email.
Com-COV2, meanwhile, showed that the shot was well-tolerated and spurred a strong immune response when given as the second dose in a mixed regimen after either AstraZeneca or Pfizer-BioNTech's vaccine, the spokesperson said.
Yet, Novavax has run into manufacturing problems, and it was recently put under a spotlight for its decision to file for authorizations using manufacturing data supported by its partner, Serum Institute of India.
The company has established manufacturing sites around the world and originally planned to have different sites play a role in separate regulatory packages, Taylor explained. Ultimately, however, the best course forward was to use the manufacturing process and initial data from Serum Institute of India, she said.
Through the regulatory process, there’s been plenty of analysis of Novavax’s manufacturing data, and “the proof is in the authorizations we’ve gotten to date,” Taylor said, admitting the company had to learn lessons about optimizing its production process along the way.
Novavax is much smaller than the Pfizer’s of the world, Taylor noted, adding “so I can say with pride that that’s one of the incredible things we’ve done as a company is stand up manufacturing.”
Novavax plans to eventually amend its authorization filings with data from additional production sites in its supply chain.
The aim is to produce at least 2 billion vaccine doses in 2022, Taylor said. Novavax has pledged 1.1 billion doses of its shot for distribution through the GAVI, WHO and CEPI co-led COVAX facility. It’s committed another 110 million doses to the U.S. Up to 430 million doses have been promised through purchase agreements to countries and regions like the U.K., Canada, Australia and the EU. And another 400 million doses will be distributed under licensing agreements with partners like Serum Institute, SK bioscience and Takeda.
Novavax’s vaccine rollout so far is “going well,” Taylor said. She pointed to Indonesia as an example. The country, which is the fourth most populous in the world, started rolling out Novavax vaccines in December. Novavax shipped about 10 million doses through Serum Institute and started getting people vaccinated within the same month.
The focus for the first quarter is on shipping its vaccine out, Taylor said. The company on Monday revealed it had started shipping doses to the Netherlands to fulfill its European contract.
Meanwhile, Novavax hasn’t launched any marketing campaigns for its vaccine just yet, but it will broadly focus on education and conveying that it’s offering a protein-based option, Taylor said. mRNA currently dominates the COVID-19 vaccine landscape, but a wide arsenal of technologies is needed to combat the pandemic, Taylor said.
The company predicts that its shot, based on a more well-understood technology platform, could help counter hesitancy among those who remain unvaccinated. Unlike mRNA, which only emerged as a vaccine platform during the pandemic’s course, Novavax’s shot is “built on a well-understood technology platform that has been used in other vaccines, like HPV,” Taylor said.
Novavax also needs to spread the word about itself as a company, Taylor said. No matter the trade name attached to the shot, people will still call it the “Novavax vaccine,” she noted.
Editor's note: This story was updated to clarify that the COVAX facility is co-led by WHO, GAVI and CEPI.