What happened to Novavax's COVID-19 vaccine candidate?

Novavax is behind its competitors in the COVID-19 vaccine race, but the biotech's vaccine is still worth keeping a close eye on because of its positive interim trial results and potential to help vaccinate other countries, according to a July 19 Kaiser Health News report.

The Gaithersburg, Md.-based company was founded in 1987 to focus on vaccine development, but it has never brought a vaccine to market. 

After Novavax's respiratory virus vaccine produced disappointing results in a late-stage trial in 2016, the biotech laid off a third of its workforce. In 2019, it sold its manufacturing capabilities.

When the pandemic emerged, Novavax adapted its vaccine platform to the novel coronavirus, growing a baculovirus inside insect cells in a bioreactor. It had entered the COVID-19 vaccine race, but it was starting at a disadvantage since the company needed to be rebuilt. The biotech needed to massively scale up its manufacturing, develop a global supply chain and create a regulatory strategy for emergency use — all steps that take years.

Novavax has run into its fair share of roadblocks while pursuing these tasks, from difficulty hiring researchers and scientists to supply chain troubles to hiccups when trying to transfer its vaccine technology.

Still, the biotech has received more than $2 billion in federal and international funding for its COVID-19 vaccine candidate, and it has several contracts it intends to fulfill.

From the federal government, the biotech was awarded two key deals: $1.74 billion from Operation Warp Speed to produce 100 million doses and $60 million from the Department of Defense to produce 10 million doses.

Novavax also promised 1.1 billion doses to Covax, the World Health Organization-backed program for equitable distribution of COVID-19 vaccines worldwide. 

In the spring, Novavax's vaccine candidate joined a U.K.-based trial testing the shot in combination with Moderna, Pfizer or AstraZeneca’s vaccines. Gregory Glenn, MD, the company's president of research and development, said the interim results show that "we’re going to be able to use our vaccine after other licensed vaccines."

In June, the biotech said its vaccine is 100 percent effective at protecting against moderate to severe COVID-19 and 90.4 percent effective overall. The data came from a phase 3 trial that enrolled 29,960 participants across 119 sites in the U.S. and Mexico.

The drugmaker has said the earliest it will apply for its vaccine candidate's approval is late July. It has also said that should the vaccine be cleared by the FDA, Novavax is ready to manufacture 150 million doses each month by the end of 2021.


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