Novavax’s Eff ort to Vaccinate the World, From

Novavax’s Eff ort to Vaccinate the World, From Zero to Not Quite Warp Speed

By Sarah Jane Tribble and Rachana Pradhan

ON A SWELTERING June morning, Novavax

CEO and covid vaccine maker Stanley Erck

stood on a stage unmasked and did something that would have been unthinkable six months ago: He shook hands with Maryland’s governor.

Erck was with Gov. Larry Hogan to announce Novavax’s global vaccine headquarters ― a campus expected to house laboratories and more than 800 employees. Hogan called Novavax’s future “bright” and marveled that more than 71% of the state’s adults had received at least one shot.

Novavax’s quest to scale up operations underscores how diffi cult it can be to launch a vaccine ― even with the formula and technology in hand. So what happened? It has had the fi nancial backing of the U.S. government and full faith of international agencies. Everything took longer than expected: hiring necessary researchers and scientists, getting supplies and transferring its vaccine technology. It didn’t move at warp speed.

“We’re not making aspirin,” Trizzino said. “We’re making a very complicated biological.”

A Moonshot Goal

A year before the covid pandemic hit, Novavax had a failed late-stage trial on a potential respiratory virus vaccine, after which it cut its workforce and sold off all its manufacturing capabilities. So, when more than $2 billion in federal and international funding landed at its doorstep, Novavax found itself developing both “a vaccine and a company” in 12 months, said Dr. Gregory Glenn, president of research and development.

Novavax’s proprietary secret ingredient is Matrix-M, an immune booster. Executives say the additive ― derived from Chilean soapbark trees ― works so well that less of an antibody-producing antigen would be needed with it in a vaccine. One fi nancial fi ling said Matrix-M “has the potential to be of immense value.”

Equipped with its recombinant nanoparticle vaccine mixed with Matrix-M, Novavax deployed a core team of employees, dubbed “SuperNOVAs,” to crisscross the globe. They assembled a manufacturing network and shared vaccine technology in India, South Korea, Spain, Japan and the Czech Republic as well as in the United States ― about 20 contract manufacturing and test sites in all.

“This takes time and expertise,” Trizzino said. “You just simply can’t hand over the recipe and then walk away from it and expect you’re going to have a high-quality product.”

Novavax is contracted to form the backbone

of the COVAX initiative, having promised 1.1 billion doses starting this year for developing countries. And while President Joe Biden announced the U.S. would donate 500 million doses of the Pfi zerBioNTech vaccine abroad, Novavax is still seen as vital to urgent eff orts worldwide to battle the virus and its variants.

Novavax’s moonshot goal of producing 2 billion shots a year increasingly looks like a pipe dream for 2021. “It is very hard to accept that they will make 2 billion doses as they had originally committed. I’m very skeptical,” said Prashant Yadav, a health care supply chain expert and senior fellow at the Center for Global Development.

One of Novavax’s biggest challenges, Yadav said, is relying on “so many sites” that aren’t fully under its control, while other manufacturers own their plants. The more places Novavax produces the vaccine, the more challenging it is to make sure the vaccine and its elements are comparable in every place.

‘Hadn’t Heard of Covid-19’

John Kutney, Novavax’s senior director of manufacturing, joined a BioBuzz video in December, in an eff ort to recruit urgently needed

talent. Kutney described the technology transfer as taking a recipe and teaching it to others. With that mission, he has traveled to the Czech Republic, Spain and the United Kingdom as well as Texas, North Carolina and New England.

When Novavax began work on its vaccine in January 2020, “most of us hadn’t heard of Covid-19 and we were only beginning to become aware of what was happening in China,” Kutney said. Novavax adapted its established vaccine platform to the new virus and then had to scale and transfer it to larger manufacturing sites, build a global supply chain and develop a regulatory strategy for emergency use.

“These steps would normally take years,” he said.

The key step of transferring Novavax’s vaccine technology can take three to six months, depending on the quality of the partner’s team. Once equipment and raw materials are secured, the teams start with small batches ― fi rst with a 50-liter bioreactor, then a 200-liter and eventually a 2,000-liter bioreactor, checking to make sure the partner operators know the process every step of the way.

“What we’re trying to do here is not easy,” said Fred Shemer, Novavax’s vice president of quality systems and compliance, in the video: “It’s a challenging situation.”

In March 2020, Novavax received the fi rst $4 million of nearly $400 million pledged by the Coalition for Epidemic Preparedness Innovations. CEPI is a global alliance backed by the Bill and Melinda Gates Foundation, which previously supported Novavax with $89 million for a vaccine for a common respiratory virus

CEPI’s investment jump-started Novavax’s technology transfer to plants across Europe and Asia. It helped Novavax partner with

SK bioscience in South Korea and paid for ramping up production at Praha Vaccines, which Novavax eventually bought, in the

Czech Republic. It also supported scaling up production of Matrix-M at facilities in Sweden and Denmark.

Operation Warp Speed awarded $1.6 billion in July 2020 to Novavax so it would produce 100 million doses ― one of the largest awards from the Trump administration’s vaccine incubator. It was “kind of a stunning number for us,” Trizzino said. In December, offi cials bumped the total to $1.74 billion with no changes to the previous contract. Novavax also has a $60 million contract with the Department of Defense for 10 million doses.

Too Late?

At the headquarters event, Glenn acknowledged that Novavax is late to the game. But the global demand is still enormous, he stressed.

“We know that 2 billion people worldwide have received at least one shot,” he said, “but there are

6 billion people that need to be inoculated.”

First, though, “the world has to collectively, as one, really stymie this global pandemic,” said Dr. Dawd Siraj, a University of Wisconsin professor specializing in infectious diseases.

Siraj said Novavax’s delays shouldn’t cast doubt on the quality of the vaccine itself, given the positive trial results it has reported globally.

The shot is a “very good vaccine,” he said, that could help turn the tide in developing countries unable to support their own vaccine development.

“Let us never miss the most important point here,” Siraj added. “Anyone who is getting a vaccine that is approved, the chances of dying, the chances of requiring ICU care, the chances of requiring a ventilator and high-fl ow oxygen, they almost disappear.” https://khn.org/news/article/covid-vaccinenovavax-vaccination-eff ort-from-zero-to-not-quitewarp-speed/