A post hoc analysis of a phase 3 randomized, controlled trial estimates that two doses of the Novavax (NVX-CoV2373) COVID-19 vaccine were 100% effective against hospitalization by 95 days during a period dominated by the SARS-CoV-2 Alpha variant.
For the analysis, published late last week in Vaccine, Novavax researchers parsed data from the PREVENT-19 trial of two doses of the Novavax vaccine or a placebo given 21 days apart to 25,482 patients in the United States and Mexico. PREVENT-19 evaluated vaccine effectiveness (VE) against moderate to severe infection but not hospitalization.
The US Food and Drug Administration (FDA) issued an emergency use authorization of Novavax on July 13, 2022. "Due to the relatively short time span since the authorization of NVX-CoV2373, real-world effectiveness data that may inform its impact on hospitalization are not yet available," the researchers wrote.
No vaccine recipients were hospitalized
From January 25 to April 30, 2021, four hospitalizations occurred among 77 events in the per-protocol efficacy population (17,312 Novavax recipients with confirmed polymerase chain reaction [PCR] infections, 8,140 controls). The hospitalizations were all among placebo recipients, for a post hoc VE of 100% (95% confidence interval [CI], 28.8% to 100%). One case was moderate, and three were severe.
In a post hoc analysis of an expanded efficacy population, which included COVID-19 hospitalizations without a requirement for PCR testing, 12 hospitalizations occurred, all among placebo recipients, for a VE against hospitalization of 100% (95% CI, 83.1% to 100%). Three infections were moderate, and eight were severe, including one death.
These results suggest that the vaccine is effective in reducing the risk of hospitalization due to COVID-19, especially in populations with pre-existing comorbid conditions and higher BMIs.
The authors noted that hospitalized patients had a high prevalence of chronic conditions, such as obesity (body mass index [BMI] of 30 or more), high blood pressure, and diabetes.
"These results suggest that the vaccine is effective in reducing the risk of hospitalization due to COVID-19, especially in populations with pre-existing comorbid conditions and higher BMIs," they wrote. "Moving forward, real-world evidence studies on the effectiveness of NVX-CoV2373 in reducing hospitalization, particularly in high-risk populations, are needed to inform global public health policies and ensure the continued success of vaccination campaigns."