“In the placebo-controlled, observer-blinded study randomized 2:1, NVX-CoV2373 demonstrated overall efficacy of 90.4% (95% CI: 82.9, 94.6)…”
Novavax might give America its fourth COVID-19 vaccine after a trial showed it is 90.4% overall efficient.
The vaccine also protects people from moderate and severe COVID-19 in the PREVENT-19 Phase 3 trial.
Stanley C. Erck, Novavax President and Chief Executive Officer, said: “Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines. These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection. Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.”
Novavax wants to file for FDA authorization in the third quarter after it completes the “final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements.”
Novavax could manufacture 100 million doses per month by the end of the third quarter if it receives FDA authorization. It could also have “150 million doses per month by the end of the fourth quarter of 2021.”
The vaccine resulted in “consistent, high efficacy among circulating variants.” From the press release:
In the placebo-controlled, observer-blinded study randomized 2:1, NVX-CoV2373 demonstrated overall efficacy of 90.4% (95% CI: 82.9, 94.6), achieving its primary endpoint. Seventy-seven cases were observed: 63 in the placebo group and 14 in the vaccine group. All cases observed in the vaccine group were mild as defined by the trial protocol. Ten moderate cases and four severe cases were observed, all in the placebo group, yielding a vaccine efficacy of 100% (95% CI: 87.0, 100) against moderate or severe disease.
Efficacy endpoints were accrued from January 25 through April 30, 2021 — a time when the Alpha (B.1.1.7) variant, first identified in the U.K., became the predominant strain in the U.S. Other strains, including Variants of Interest (VoI) and Variants of Concern (VoC), were also on the rise during the PREVENT-19 endpoint accrual window. Click here for CDC definitions of variants.
Sequence data are available for 54 of the 77 cases. PREVENT-19 met its key secondary endpoint, demonstrating 100% efficacy (95% CI: 80.8, 100) against variants not considered VoC/VoI. Of the sequenced cases, 35 (65%) were VoC, 9 (17%) were VoI, and 10 (19%) were other variants. Against VoC/VoI, which represented 82% of the cases, vaccine efficacy was 93.2% (95% CI: 83.9, 97.1), achieving a key exploratory endpoint of the study. Thirty-eight of the VoC/VoI cases were in the placebo group and 6 were in the vaccine group.
NVX-CoV2373 also showed success among “high-risk” populations (defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure): vaccine efficacy was 91.0% (95% CI: 83.6, 95.0), with 62 COVID-19 cases in the placebo group and 13 COVID-19 cases in the vaccine group.
Serious & severe adverse events were low in number & balanced between vaccine & placebo groups. pic.twitter.com/A8uS9l16tx
— Novavax (@Novavax) June 14, 2021
I love that it tested on people under 65-years-old with health problems. The fast trials of the other vaccines caused my rheumatologist to hesitate right away. After her own observation, she gave me the okay in March to get it, but I had to give her daily updates and not take my immuno-suppressant medicine.
Novavax might encounter some roadblocks since we already have three vaccines. The FDA could tell the company to apply for a full license, which takes several months.
Erck hopes the date “gives everybody an incentive to pay attention to our filings.”
Natalie Dean, a University of Florida biostatistician, described the results as “strong” and puts Novavax “in that high tier.”
The vaccine could help out with booster shots:
By the time Novavax gets the green light from the U.S. government, it may be too late to contribute to the country’s first wave of vaccinations. But many vaccine experts expect that, with waning immunity and emerging variants, the country will need booster shots at some point. And the protein-based technology used in the Novavax vaccine may do a particularly good job at amplifying protection, even if people have previously been vaccinated with a different formulation.
“They may be really the right ones for boosters,” said Dr. Luciana Borio, who was the acting chief scientist at the F.D.A. from 2015 to 2017.
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