LONDON — American biotechnology company Novavax announces Monday that its experimental COVID-19 vaccine was more than 90% effective against symptomatic disease in late-stage clinical trials.
According to a company press release, the Phase 3 trial, which enrolled nearly 30,000 people across 119 sites in the United States and Mexico, found that Novavax’s recombinant protein-based vaccine, called NVX-CoV2373, provided 100 percent protection against moderate and severe cases of COVID-19, with an overall efficacy of 90.4 percent.
In a statement released Monday, Stanley Erck, president and CEO of Novavax, stated, “Today, Novavax is one step closer to addressing the essential and chronic worldwide public health demand for more COVID-19 vaccinations.” “These clinical data demonstrate that NVX-CoV2373 is very effective and provides complete protection against COVID-19 infection in both mild and severe cases.”
In the randomized, placebo-controlled, observer-blinded investigation, researchers found 77 instances of COVID-19. The placebo group had 63 instances, whereas the vaccination group had 14. The placebo group included ten mild and four severe cases. According to Novavax, all of the instances in the vaccination group were minor.
For 54 of the 77 cases, sequence data is available, revealing that 35 were coronavirus strains classified as “variants of concern” by the US Centers for Disease Control and Prevention, nine were “variants of interest,” and ten were other variants not classified as “of concern” or “of interest” by the CDC.
The two-shot vaccination from Novavax was shown to be 93.2 percent effective against the variations of concern and interest, which made up 82 percent of the sequenced cases. According to the press release, 38 of those instances were in the placebo group and five were in the vaccination group.
The vaccine, which can be kept in the refrigerator, also showed 91 percent efficiency in high-risk populations, such as persons over 65 and those under 65 with particular comorbidities or who are often exposed to COVID-19. According to Novavax, 62 of the COVID-19 instances were in the placebo group and 13 were in the vaccination group.
The vaccination was generally well-tolerated, according to preliminary safety data from the research, with significant and severe side events being low in number and evenly distributed across the vaccination and placebo groups. In the vaccination group, no one adverse event occurred more than 1% of the time. According to the press release, the most prevalent symptoms in the days after the first and second doses were injection site discomfort and soreness, weariness, headache, and muscular discomfort.
“These results indicate constant, high levels of effectiveness and underline the vaccine’s capacity to prevent COVID-19 despite the virus’s continuous genetic evolution,” stated Dr. Gregory Glenn, president of Novavax’s research and development.
Novavax said it plans to release more information on the Phase 3 study results when more information becomes available. The experiment is still being analyzed, and the results will be submitted to peer-reviewed publications for publication. Meanwhile, according to the press release, the placebo-controlled section of the trial is still ongoing in the 12 to 17 age range, which just concluded enrollment with 2,248 participants.
The US Food and Drug Administration has yet to approve NVX-CoV2373, according to Novavax. The Maryland-based firm stated that it plans to apply for regulatory approval in the third quarter of 2021.
According to the press release, the business expects to attain a manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the fourth quarter, pending regulatory clearances.
“Novavax continues to work with a feeling of urgency to finish our regulatory applications and deliver this vaccine, which is based on a well-understood and established technology, to a world in desperate need of vaccinations,” Erck added.
The federal government gave Novavax $1.6 billion last year to finish late-stage clinical trials as part of the US commitment to develop, produce, and deliver COVID-19 vaccines.