A volunteer received a COVID-19 vaccine candidate or placebo in the Phase III trial launched by Novavax in the UK in October.
Kirsty O’Connor / Press Association via AP Images
By Meredith Wadman
ScienceCOVID-19’s reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.
Novavax, a once-struggling biotechnology company saved with $ 2 billion in funds for its promising COVID-19 vaccine candidate from the Coalition for Epidemic Preparedness Innovations and the U.S. government, today announced the long-awaited start of its U.S. efficacy test. Novavax has already entered an efficiency test in the UK with more than 15,000 volunteers, whose data it wants to use to support the application for European regulatory approval.
But the British trial has not yet yielded its results, and the company has postponed the launch of its larger US trial several times this autumn because it has struggled to step up vaccine production. The results of the candidate’s first human trial, announced in August, were promising. Nevertheless, Novavax has never given regulatory approval to any of its candidates, and despite a nearly thirty-year history of making vaccines, and whether the pandemic will eventually change, it remains to be seen.
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Novavax’s COVID-19 candidate is one of two vaccines for protein subunits – the other was manufactured by the vaccine giant Sanofi Pasteur, on which the US government bet billions of dollars, and the first one which conducted a major test for efficacy. It consists of small lipid particles strewn with copies of the vein protein from the pandemic coronavirus SARS-CoV-2. The lipids of the vaccine do not contain the polymer-polyethylene glycol that causes allergic reactions to other COVID-19 vaccines, but are supplemented by an immune-boosting, herbal compound, saponins.
Two-thirds of up to 30,000 volunteers in the North American placebo-controlled trial will receive the active vaccine. There will be 108 U.S. trial sites and seven in Mexico
The company acknowledged that the availability of two vaccines with a proven efficacy of more than 90%, manufactured by PfizerBioNTech and Moderna and approved by the Food and Drug Administration for emergency use this month, could make people hesitate to sign up for the US trial, given the chance of getting an inert placebo or that the Novavax candidate is less protective.
“Volunteers considering our trial may have questions about … their ability to receive an authorized vaccine when it’s available to them,” said Gregory Glenn, president of research and development. “We … are working to ensure that their involvement in our trial does not adversely affect their ability to be vaccinated at the right time.”
Novyax spokeswoman Amy Speak added: “If we find that we are not enrolling people in one site, we have backup sites that we can activate.”
At least one veteran of the vaccine says recruiting 30,000 volunteers is a difficult hill to climb. ‘Why would anyone go to a placebo-controlled study with them? Most of the altruistic people who are willing to do a vaccine study have already enrolled, ‘says Vijay Samant, who previously led the manufacture of vaccines at Merck. “It’s going to be harder and harder to recruit as time goes on.”
For more information on Novavax’s COVID-19 vaccination, see our previous feature.