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Objectives: To assess the causal impact of a spontaneous relaxation of social distancing on the spread of SARS-CoV-2 in the United States (U.S.), while controlling for social mobility and state-imposed social distancing restrictions. Design: Event study. Setting: Quasi-experimental setting created by the U.S. nationwide protests precipitated by George Floyd's tragic death on May 25, 2020. Population: Individuals in 3,142 U.S. counties from all 50 states and the District of Columbia. Main Outcome Measures: The number of daily confirmed COVID-19 cases in all U.S. counties between the period of January 22, 2020, and June 20, 2020, and the cumulative change in COVID-19 cases in protest counties relative to non-protest counties following the onset of the protests. Results: We document a country-wide increase of over 3.06 cases per day, per 100,000 population, following the onset of the protests (95%CI: 2.47-3.65), and a further increase of 1.73 cases per day, per 100,000 population, in the counties in which the protests took place (95%CI: 0.59-2.87).

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The vaccine uses a harmless-to-humans chimpanzee adenovirus as a delivery vector. That virus is modified to carry spike proteins from SARS-CoV-2—the component of the coronavirus that, in theory, should induce the sought-after immune response in humans.

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Abstract

Background NVX-CoV2373 is a recombinant nanoparticle vaccine composed of trimeric full-length SARS-CoV-2 spike glycoproteins. We present the Day 35 primary analysis of our trial of NVX-CoV2373 with or without the saponin-based Matrix-M1 adjuvant in healthy adults. Methods This is a randomized, observer-blinded, placebo-controlled, phase 1 trial in 131 healthy adults. Trial vaccination comprised two intramuscular injections, 21 days apart. Primary outcomes were reactogenicity, safety labs, and immunoglobulin G (IgG) anti-spike protein response. Secondary outcomes included adverse events, wild-type virus neutralizing antibody, and T-cell responses. Results Participants received NVX-CoV2373 with or without Matrix-M1 (n=106) or placebo (n=25). There were no serious adverse events. Reactogenicity was mainly mild in severity and of short duration (mean ? 2 days), with second vaccinations inducing greater local and systemic reactogenicity. The adjuvant significantly enhanced immune responses and was antigen dose-sparing, and the two-dose 5?g NVX-CoV2373/Matrix-M1 vaccine induced mean anti-spike IgG and neutralizing antibody responses that exceeded the mean responses in convalescent sera from COVID-19 patients with clinically significant illnesses. The vaccine also induced antigen-specific T cells with a largely T helper 1 (Th1) phenotype. Conclusions NVX-CoV2373/Matrix-M1 was well tolerated and elicited robust immune responses (IgG and neutralization) four-fold higher than the mean observed in COVID-19 convalescent serum from participants with clinical symptoms requiring medical care and induced CD4+ T-cell responses biased toward a Th1 phenotype. These findings suggest that the vaccine may confer protection and support transition to efficacy evaluations to test this hypothesis. (Funded by the Coalition for Epidemic Preparedness Innovations; ClinicalTrials.gov number, NCT04368988).