Novavax May Find COVID-19 Sweet Spot as a Booster
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Novavax announced today that its protein-based COVID-19 vaccine, NVX-CoV2373, is included in two new clinical trials that are now underway. The trials will evaluate the vaccine as a potential booster for COVID-19 in three key areas: safety, immunogenicity and reactogenicity.
Both studies have already begun to initiate enrollment. If the trials are successful, they will not only show how Novavax’s vaccine can be used as a booster but also open the door for other vaccines to be used as boosters after primary immunization.
This news comes one month after the company announced positive data from Phase III of its PREVENT-19 trial, which studied the effects of its vaccine in adolescents aged 12 to 17 years old in the United States. The vaccine achieved an 80% overall efficacy and was conducted when the SARS-CoV-2's Delta variant was the predominant strain.
Though the new trials announced involve the use of the same vaccine, they will only include adult participants. One of the studies, sponsored by the National Institute of Allergy & Infectious Diseases (NIAID), is an ongoing Phase I/II trial aimed to assess boosting regiments in people who received a previous series of an Emergency Use Authorization or Food and Drug Administration (FDA)-approved Covid-19 vaccine.
Participants will either be given a dose of NVX-CoV2373 or a third dose of the same vaccine they’ve already received. Novavax plans to enroll about 1,130 healthy adults, and approximately 180 of those participants will receive NVX-CoV2373.
The participants will then be monitored for one full year. Novavax expects to announce top-line results later this year and full results in 2023.
The second trial is a Phase III study in the United Arab Emirates. It will only include participants who have been previously vaccinated with Sinopharm's COVID-19 vaccine and will assess the safety and immunogenicity of a single booster dose of Novavax's COVID-19 vaccine. The Ministry of Health and Prevention approved NVX-CoV2373 for emergency use in the UAE in December.
Novavax plans to enroll about 1,000 adults who will then be monitored for six months. The company expects to report full results during the fourth quarter of 2022.
Filip Dubovsky, M.D., chief medical officer at Novavax, said he is looking forward to the results of the trials.
“Additional COVID-19 booster studies are important to support vaccine choice for individuals, healthcare providers, and public health authorities," Dubovsky said in a statement. "Our COVID-19 vaccine has already been recommended by multiple national policy bodies for both primary vaccination and booster settings in individuals 18 years of age and older. We look forward to adding to this body of evidence to support the expanded use of our protein-based vaccine."