On a hot June morning, Novavax CEO and covid vaccine maker Stanley Erck stood unmasked on a stage and did something unthinkable six months ago: he shook hands with Maryland’s governor.
Erck joined Gov. Larry Hogan in announcing Novavax’s global vaccine headquarters, a campus that will house laboratories and over 800 employees. Hogan described Novavax’s future as “bright,” noting that more than 71% of the state’s adults had received at least one shot. None of them was a Novavax vaccine, which is still unavailable to the general public in the United States due to delayed clinical trial results and other issues. Hogan, for his part, received his first vaccine dose in January from fellow biotech upstart Moderna.
Novavax has been able to stay afloat for decades thanks to its strong ties to grant makers and federal agencies. Erck believes Novavax is “built for this moment” because of its focus on developing vaccines, including those for the SARS and MERS pandemics. Despite this, the 34-year-old company has never brought one to market.
Novavax’s quest to expand operations demonstrates how difficult it can be to launch a vaccine ― Despite having the formula and technology at hand. So, what exactly happened? It has received financial support from the US government as well as the full trust of international organizations. Hiring the necessary researchers and scientists, obtaining supplies, and transferring its vaccine technology all took longer than expected. It wasn’t moving at warp speed.
America is flooded with vaccine options, and Novavax does not intend to file for regulatory approvals until late July at the earliest. The delay could have serious consequences for people all over the world who are waiting for a vaccine.
Novavax had a failed late-stage trial on a potential respiratory virus vaccine a year before the covid pandemic, after which it cut its workforce and sold off all of its manufacturing capabilities. As a result, when more than $2 billion in federal and international funding arrived, Novavax found itself developing both “a vaccine and a company” in a year, according to Dr. Gregory Glenn, president of research and development.
Matrix-M, an immune booster, is Novavax’s proprietary secret ingredient. According to executives, the additive derived from Chilean soapbark trees works so well that it would require less of an antibody-producing antigen in a vaccine. According to one financial filing, Matrix-M “has the potential to be of enormous value.”
Novavax sent a core team of employees, dubbed “SuperNOVAs,” around the world with its recombinant nanoparticle vaccine mixed with Matrix-M. They established a manufacturing network and shared vaccine technology in India, South Korea, Spain, Japan, and the Czech Republic, in addition to the United States, totaling approximately 20 contract manufacturing and testing sites.
Novavax has been contracted to serve as the backbone of the COVAX initiative, promising 1.1 billion doses for developing countries beginning this year. While President Joe Biden announced that the United States would donate 500 million doses of the Pfizer-BioNTech vaccine to other countries, Novavax is still seen as critical to urgent global efforts to combat the virus and its variants.
Novavax’s moonshot goal of producing 2 billion shots per year by 2021 appears to be a pipe dream. “It is difficult to accept that they will produce 2 billion doses as originally committed. “I’m skeptical,” said Prashant Yadav, a senior fellow at Harvard’s Center for Global Development and a health care supply chain expert.
One of Novavax’s most difficult challenges, according to Yadav, is relying on “so many sites” that aren’t completely under its control, whereas other manufacturers own their plants. The more places Novavax manufactures the vaccine, the more difficult it is to ensure that the vaccine and its components are comparable in each location.