Novavax gains $1.6 billion from HHS, DoD for millions of potential vaccine doses

Rewards are rolling out from the Trump administration’s Operation Warp Speed this week, including $1.6 billion — allotted from the Departments of Health and Human Services (HHS) and Defense (DoD) — given to Novavax, Inc. for 100 million doses of a possible COVID-19 vaccine.

While the Maryland biotech company has not yet brought any products successfully to market, the government found its latest product, the perfusion protein-based candidate NVX-CoV2373, to have enough potential to merit demonstration of commercial-scale manufacturing. The federal government will own all doses produced by that demo after that, for use either in clinical trials or, if approved by the Food and Drug Administration (FDA), for wider distribution.

“Operation Warp Speed is creating a portfolio of vaccines to increase the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” HHS Secretary Alex Azar said. “Depending on success in clinical trials, today’s $1.6 billion investment supports our latest vaccine candidate, being developed by Novavax, all the way through clinical trials and manufacturing 100 million doses for the American people.”

With that said, Novavax already signed onto an up-to $388 million agreement with the Coalition for Epidemic Preparedness (CEPI), a stipulation of which required grantees to give right of first refusal of vaccines to the Covax facility, an entity established by CEPI, Gavi, the Vaccine Alliance, and the World Health Organization as a means to guarantee COVID-19 vaccines for non-producing countries. Another approximately $70 million were previously given by the DoD as well, for 10 million doses slated for use in Phase 2/3 clinical trials or under emergency use authorization (EUA).

“The pandemic has caused an unprecedented public health crisis, making it more important than ever that industry, government, and funding entities join forces to defeat the novel coronavirus together,” Novavax President and CEO Stanley Erck said. “We are honored to partner with Operation Warp Speed to move our vaccine candidate forward with extraordinary urgency in the quest to provide vital protection to our nation’s population. We are grateful to the U.S. government for its confidence in our technology platform, and are working tirelessly to develop and produce a vaccine for this global health crisis.”

Clinical trials are currently underway, and the manufacturing demonstration will take place concurrently with them. The Trump administration has insisted this will allow months to be shaved off the traditional vaccine development timeline and, under its Operational Warp Speed, is pushing hard for 300 million doses of COVID-19 vaccines by 2021.

The FDA can issue EUAs for unapproved products if they meet certain statutory requirements. For investigational vaccines, like this one, assessments would be based on clinical trial data and the total scientific evidence made available on the vaccine candidate. Further analysis would be required for the actual licensing of the vaccine.

In addition to the demonstration, the $1.6 billion in funding will benefit a Phase 3 clinical trial of up to 30,000 participants later this year. The agreement also grants the option of a follow-on agreement with the U.S. government to push still greater production and procurement in support of its vaccine production goal.

While any doses produced could be made available to U.S. residents at no additional cost under a vaccination campaign, healthcare professionals would still be able to charge insurers for the cost of administering it.