scholarly journals Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico

2021 ◽  
Author(s):  
Lisa M. Dunkle ◽  
Karen L. Kotloff ◽  
Cynthia L. Gay ◽  
German Anez ◽  
Jeffrey M. Adelglass ◽  
...  
Keyword(s):  
United States ◽  
Controlled Trial ◽  
The United States ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
S Protein ◽  
Viral Genomes ◽  
The United Kingdom ◽  
To Receive ◽  
Placebo Recipients

BACKGROUND Vaccination using severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein antigen has been effective in the prevention of coronavirus disease 2019 (Covid-19). NVX-CoV2373 is an adjuvanted, recombinant S protein nanoparticle vaccine that demonstrated clinical efficacy for prevention of Covid-19 in phase 2b/3 trials in the United Kingdom and South Africa. METHODS This phase 3, randomized, observer-blinded, placebo-controlled trial evaluated the efficacy and safety of NVX-CoV2373 in adults ≥18 years of age in the United States and Mexico during the first quarter of 2021. Participants were randomized in a 2:1 ratio to receive two doses of NVX-CoV2373 or placebo 21 days apart. The primary end point was vaccine efficacy (VE) against reverse transcriptase-polymerase chain reaction-confirmed Covid-19 in SARS-CoV-2-naive participants ≥7 days after the second dose administration. RESULTS Of the 29,949 participants randomized between December 27, 2020, and February 18, 2021, 29,582 (median age: 47 years, 12.6% ≥65 years) received ≥1 dose: 19,714 received vaccine and 9868 placebo. In the per-protocol population, there were 77 Covid-19 cases; 14 among vaccine and 63 among placebo recipients (VE: 90.4%, 95% confidence interval [CI] 82.9 to 94.6, P<0.001). All moderate-to-severe cases occurred in placebo recipients, yielding VE of 100% (95% CI 87.0 to 100). Most sequenced viral genomes (48/61, 78.7%) were variants of concern (VOC) or interest (VOI), mainly represented by variant alpha/B.1.1.7 (31/35, 88.6% VOC identified). VE against any VOC/VOI was 92.6% (95% CI 83.6 to 96.7). Reactogenicity was mostly mild-to-moderate and transient, but more frequent in NVX-CoV2373 recipients and after the second dose. Serious adverse events were rare and evenly distributed between treatments. CONCLUSIONS NVX-CoV2373 was well tolerated and demonstrated a high overall VE (>90%) for prevention of Covid-19, with most cases due to variant strains. (Funded by the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health; PREVENT-19 ClinicalTrials.gov number, NCT04611802.)

scholarly journals Effects of Side-Effect Risk Framing Strategies on COVID-19 Vaccine Intentions in the United States and the United Kingdom: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Nikkil Sudharsanan ◽  
Caterina Favaretti ◽  
Violetta Hachaturyan ◽  
Till Baernighausen ◽  
Alain Vandormael
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Side Effect ◽  
Motor Vehicle ◽  
Controlled Trial ◽  
The United States ◽  
Randomized Controlled ◽  
The United Kingdom ◽  
Percentage Points ◽  
Framing Strategies

Vaccination rates have stagnated in the United States and the United Kingdom leading to the continuing spread of COVID-19. Fear and concern over vaccine side-effects is one of the main drivers of hesitancy. Drawing from behavioral science and health communication theory, we conducted a randomized controlled trial among 8998 adults to determine whether the way COVID-19 vaccine side-effects are framed and presented to individuals can influence their willingness to take a vaccine. We presented participants information on a hypothetical future COVID-19 vaccine -- including information on its side-effect rate -- and then examined the effect of three side-effect framing strategies on individuals stated willingness to take this vaccine: adding a qualitative risk label next to the numerical risk, adding comparison risks, and for those presented with comparisons, framing the comparison in relative rather than absolute terms. Based on a pre-registered and published analysis plan, we found that adding a simple descriptive risk label (very low risk) next to the numerical side-effect increased participants' willingness to take the COVID-19 vaccine by 3.0 percentage points (p = 0.003). Providing a comparison to motor vehicle mortality increased COVID-19 vaccine willingness by 2.4 percentage points (p = 0.051). These effects were independent and additive: participants that received both a qualitative risk label and comparison to motor-vehicle mortality were 6.1 percentage points (p < 0.001) more likely to report willingness to take a vaccine compared to those who did not receive a label or comparison. Taken together, our results reveal that despite increasingly strong vaccination hesitancy and exposure to large amounts of vaccine misinformation, low-cost side-effect framing strategies can meaningfully affect vaccination intentions at a population level.

Effectiveness of Programs for the Prevention of Child Sexual Abuse

2020 ◽  
Vol 25 (1) ◽  
pp. 1-15 ◽  
Author(s):  
Amaia Del Campo ◽  
Marisalva Fávero
Keyword(s):  
United States ◽  
Sexual Abuse ◽  
New Zealand ◽  
Critical Analysis ◽  
Prevention Programs ◽  
The United States ◽  
Sexual Abuse Prevention ◽  
Negative Effects ◽  
The United Kingdom ◽  
Methodological Considerations

Abstract. During the last decades, several studies have been conducted on the effectiveness of sexual abuse prevention programs implemented in different countries. In this article, we present a review of 70 studies (1981–2017) evaluating prevention programs, conducted mostly in the United States and Canada, although with a considerable presence also in other countries, such as New Zealand and the United Kingdom. The results of these studies, in general, are very promising and encourage us to continue this type of intervention, almost unanimously confirming its effectiveness. Prevention programs encourage children and adolescents to report the abuse experienced and they may help to reduce the trauma of sexual abuse if there are victims among the participants. We also found that some evaluations have not considered the possible negative effects of this type of programs in the event that they are applied inappropriately. Finally, we present some methodological considerations as critical analysis to this type of evaluations.

Science, Politics, and the Pandemic

2020 ◽  
Vol 119 (820) ◽  
pp. 303-309
Author(s):  
J. Nicholas Ziegler
Keyword(s):  
United States ◽  
Biomedical Research ◽  
Scale Up ◽  
Political Leadership ◽  
The United States ◽  
Scientific Advice ◽  
The United Kingdom ◽  
Effective Policy ◽  
Scientific Expertise ◽  
The Uk

Comparing the virus responses in Germany, the United Kingdom, and the United States shows that in order for scientific expertise to result in effective policy, rational political leadership is required. Each of these three countries is known for advanced biomedical research, yet their experiences in the COVID-19 pandemic diverged widely. Germany’s political leadership carefully followed scientific advice and organized public–private partnerships to scale up testing, resulting in relatively low infection levels. The UK and US political responses were far more erratic and less informed by scientific advice—and proved much less effective.

Sign in / Sign up

Export Citation Format

Share Document