As sales of its COVID vaccine plummet, Novavax is looking ahead toward other novel vaccines, brought to market with the help of the company’s pharma partners—something it opted not to do as the pandemic swept the globe in 2020.
The story could have been much different for Novavax. The Maryland-based biopharma developed and secured the FDA’s greenlight for a COVID-19 vaccine in less than two and a half years; the only problem? Three other vaccines got to market even faster.
It typically takes some 5 to 10 years to develop a vaccine. Thanks to a combination of extreme urgency, government funding and strategic partnering, Pfizer and BioNTech’s COVID-19 vaccine Comirnaty won the first FDA emergency use authorization (EUA) on Dec. 11, 2020, exactly nine months after the World Health Organization officially declared the pandemic on March 11. Moderna’s Spikevax and Johnson & Johnson’s COVID-19 vaccine quickly followed. Novavax’s Nuvaxovid won FDA emergency use authorization in July 2022.
The first-to-market advantage was significant: Pfizer reported a whopping $36.8 billion in sales from Comirnaty in 2021 and another $37.8 billion in 2022 while Novavax saw only $1.5 billion from Nuvaxovid in the time it was on the market in 2022. All have since encountered the so-called “COVID cliff,” with sales falling off considerably as the pandemic has waned.
Ahead of the five-year anniversary of the WHO declaration, BioSpace sat down with Silvia Taylor, EVP and chief corporate affairs and advocacy officer at Novavax, to discuss her company’s experience on the front lines of the COVID-19 pandemic.
“I guess that was one of the learnings, that speed is really relative,” Taylor said. “This is just a hypothetical, but what if others had taken three years and we would have taken two?” In that case, she mused, rather than wondering why Novavax fell behind, the question would have been, “What made you so successful?”
Strategic Lessons Learned
For context, Taylor compared Novavax to Germany’s BioNTech as being “the small innovator” in the global health crisis.
Unlike BioNTech, however, Novavax elected to go it alone at the development stage. “We had a little bit more time to scale and build a commercial infrastructure and build distribution capabilities, and so we chose to do that,” Taylor said. “Now, with the benefit of hindsight, could we have been potentially faster? We have no idea. We can’t speculate on what didn’t happen.”
While Taylor indicated that Novavax’s technology made its vaccine an attractive option, it may also have delayed its development. Protein-based technology—on which Novavax’s Nuvaxovid is built—is “terrific,” Taylor said. “It just doesn’t happen as quickly [as mRNA].”
But speed is not the only consideration, Taylor emphasized, adding that it’s important to think about what the world really needs when it comes to infectious diseases with pandemic potential. “It’s incredibly important to have multiple technology platforms . . . because we know not every one is right for every person.”
While Novavax didn’t partner with another pharmaceutical company at the early stages, it has leveraged several collaborations during the post-approval phase. Nuvaxovid was, after all, the 38-year-old company’s first-ever commercial launch, Taylor noted. “We were really in a learning mode.”
In May 2024, the company signed a licensing agreement with Sanofi in which the larger pharma took the “lead role” in commercializing the vaccine, according to Taylor. Additionally, Novavax has signed material transfer agreements with two other “major pharmaceutical companies,” though Taylor could not disclose any further details.
These material transfers “give other companies access, in this case, to our adjuvant matrix, and allow them to study it and understand how they might apply that to their own portfolios, their own vaccines in development,” she said.
Partnering is also a key element of Novavax’s COVID-19 strategy moving forward. The company currently has a combination COVID-19/influenza vaccine in Phase III development. For this product, Taylor said Novavax decided not to do full-scale development or commercialize the vaccine without a partner. So, while the company awaits data from that trial—which it expects in mid-2025—it is also “having a lot of productive conversations with potential partners,” Taylor said. “We’ve learned and decided that’s what we want to do.”
Novavax is also in conversations with the FDA about a potential accelerated approval pathway for the combo vaccine. If that comes to fruition, it could give Novavax an advantage in a space where it once again faces stiff competition. Moderna released positive Phase III data for its combination COVID-19/influenza vaccine, mRNA-1083, in June 2024, while Pfizer and BioNTech reported mixed Phase III data for their own combo in August of the same year. Moderna’s product is currently under FDA review, while Pfizer and BioNTech’s data left the partners “evaluating the next steps” for the vaccine.
However, Novavax’s wholly owned combination COVID-19-flu vaccine is not its only shot on this particular goal. The Sanofi pact also gave the larger pharma a license to combine Nuvaxovid with one of its market leading flu vaccines, “and they’ve decided to do that, not with just one candidate, but two,” Taylor said. Both vaccines were granted FDA fast track designation in December 2024.
“I think combination therapies, where you can target two infectious diseases with one vaccine, that’s where the [COVID-19] market’s going,” Taylor said.
‘Readiness Posture’
While Novavax awaits revenue for these potential products, it is facing the same COVID cliff as its peers.
Last month, the company revealed its Q4 and full-year 2024 earnings, reporting $50 million in Nuvaxovid sales in the fourth quarter compared to $251 million in the same period the previous year. Total 2024 Nuvaxovid revenue was $190 million compared to $531 million in 2023.
But Novavax is looking forward. “[COVID] was never our long-term strategy,” Taylor said. “We saw the fact that we were able to get our COVID vaccine out as validation of our technology platform and our ability as an innovator.”
In its earnings report, Novavax CEO John Jacobs laid out three strategic priorities: the Sanofi partnership, leveraging its technology platform and pipeline to forge additional partnerships and advancing its technology platform and early-stage pipeline. On that note, the company has an experimental vaccine for avian flu (H5N1) ready for clinical development.
“If we were able to do this for COVID-19,” Taylor said, “what if, for example, an avian influenza pandemic hits?”
When developing its COVID-19 vaccine, Novavax leveraged funding from both the Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S. government’s Operation Warp Speed. While H5N1 is still simmering—76 people, mainly farm workers, were infected with the H5 avian influenza strain in 2024, according to the United Nations—Novavax is already in talks with organizations that provide non-dilutive funding “to explore the potential of getting that funding to take that to the next level,” Taylor said. “That’s the readiness posture of the world, of the U.S. We’re ready to continue that development.”
On a broader scale, Taylor said the pharmaceutical industry also learned a lot about communication during a global pandemic. “I think misinformation was so rampant during the [COVID-19] pandemic, but . . . I don’t know that it impacted our vaccine so much as people’s attitudes toward vaccination in general.”
Indeed, flu vaccination rates have declined since the pandemic, with 9.2 million fewer doses being administered in pharmacies and doctor’s offices compared with an average year prior to COVID-19, according to The Conversation.
Going forward, Taylor said, things need to change. “I think that everybody from public health officials within government, NGOs, pharmaceutical companies, we all have to think about, how do we put information out there in a very consistent and concise way?” Although that didn’t happen during COVID, lessons have been learned, she said. “We’ll never be the same again.”
