A volunteer receives a COVID-19 vaccine candidate or a placebo in October in the Novavax phase III study launched in the United Kingdom.
Kirsty O’Connor / Press Association via AP Images
By Meredith Wadman
ScienceCOVID-19 reports are supported by the Pulitzer Center and the Heising-Simons Foundation.
Novavax, a biotechnology company that previously struggled and was rescued by $ 2 billion in funding for its promising vaccine candidate COVID-19 from the Coalition for Epidemic Preparedness Innovations and the US government, today announced the long-awaited start of its effectiveness test In the USA. Novavax has already signed up for an effectiveness trial in the UK with more than 15,000 volunteers, whose data he plans to use to support his European regulatory approval request.
But the test in the UK has yet to show results, and the company has postponed the launch of its biggest test in the United States several times this fall, while struggling to increase vaccine production. The results of the candidate’s first human trial, announced in August, were promising. However, despite a nearly 30-year history of producing vaccines, Novavax has never obtained regulatory approval for one of its candidates, and if the pandemic will finally change, it remains to be seen.
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Novavax’s COVID-19 candidate is one of two protein subunit vaccines – the other is made by giant vaccine maker Sanofi Pasteur – on which the U.S. government has staked billions of dollars, and the first to enter an effectiveness test fundamental. It consists of tiny lipid particles studded with copies of the spike protein from the pandemic coronavirus SARS-CoV-2. The vaccine’s lipids do not contain the polyethylene glycol polymer that raised concerns about allergic reactions to other COVID-19 vaccines, but is supplemented by a plant-derived compound that boosts the immune system, called saponin.
Two-thirds of up to 30,000 volunteers in the American placebo-controlled study will receive the active vaccine. There will be 108 test sites in the US and seven in Mexico
The company recognized that the availability of two more than 90% proven vaccines, made by PfizerBioNTech and Moderna and authorized for emergency use by the Food and Drug Administration this month, may make people hesitate to enroll in their U.S. trial, given the chance of getting an inert placebo or the Novavax candidate being less protective.
“The volunteers who are considering our study may have questions about … their ability to receive an authorized vaccine when it becomes available to them,” said Gregory Glenn, the company’s president of research and development. “We are … working to ensure that their involvement in our study does not negatively affect their ability to be vaccinated at the appropriate time.”
Novavax spokeswoman Amy Speak added: “If we find out that we are not enrolling people in one location, we have backup sites that we can activate.”
At least one vaccine veteran says recruiting 30,000 volunteers will be a difficult hill to climb. “Why would anyone do a placebo-controlled study with them? Most altruistic people who want to get into a vaccine study have already signed up, ”says Vijay Samant, who previously led Merck’s vaccine manufacturing. “It will be increasingly difficult to recruit over time.”
For more information on Novavax’s COVID-19 vaccine effort, see our previous article.