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Risk of COVID-19 after natural infection or vaccination

Rick, Anne-Marie; Laurens, Matthew B; Huang, Ying; Yu, Chenchen; Martin, Thomas C S; Rodriguez, Carina A; Rostad, Christina A; Maboa, Rebone M; Baden, Lindsey R; El Sahly, Hana M; Grinsztejn, Beatriz; Gray, Glenda E; Gay, Cynthia L; Gilbert, Peter B; Janes, Holly E; Kublin, James G; Huang, Yunda; Leav, Brett; Hirsch, Ian; Struyf, Frank; Dunkle, Lisa M; Neuzil, Kathleen M; Corey, Lawrence; Goepfert, Paul A; Walsh, Stephen R; Follmann, Dean; Kotloff, Karen L; NIAID-funded COVID-19 Prevention Network (CoVPN)
BACKGROUND:While vaccines have established utility against COVID-19, phase 3 efficacy studies have generally not comprehensively evaluated protection provided by previous infection or hybrid immunity (previous infection plus vaccination). Individual patient data from US government-supported harmonized vaccine trials provide an unprecedented sample population to address this issue. We characterized the protective efficacy of previous SARS-CoV-2 infection and hybrid immunity against COVID-19 early in the pandemic over three-to six-month follow-up and compared with vaccine-associated protection. METHODS:In this post-hoc cross-protocol analysis of the Moderna, AstraZeneca, Janssen, and Novavax COVID-19 vaccine clinical trials, we allocated participants into four groups based on previous-infection status at enrolment and treatment: no previous infection/placebo; previous infection/placebo; no previous infection/vaccine; and previous infection/vaccine. The main outcome was RT-PCR-confirmed COVID-19 >7-15 days (per original protocols) after final study injection. We calculated crude and adjusted efficacy measures. FINDINGS/RESULTS:Previous infection/placebo participants had a 92% decreased risk of future COVID-19 compared to no previous infection/placebo participants (overall hazard ratio [HR] ratio: 0.08; 95% CI: 0.05-0.13). Among single-dose Janssen participants, hybrid immunity conferred greater protection than vaccine alone (HR: 0.03; 95% CI: 0.01-0.10). Too few infections were observed to draw statistical inferences comparing hybrid immunity to vaccine alone for other trials. Vaccination, previous infection, and hybrid immunity all provided near-complete protection against severe disease. INTERPRETATION/CONCLUSIONS:Previous infection, any hybrid immunity, and two-dose vaccination all provided substantial protection against symptomatic and severe COVID-19 through the early Delta period. Thus, as a surrogate for natural infection, vaccination remains the safest approach to protection. FUNDING/BACKGROUND:National Institutes of Health.
PMID: 37738833
ISSN: 2352-3964
CID: 5572452

Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 randomized open-label COVAIL trial

Branche, Angela R; Rouphael, Nadine G; Diemert, David J; Falsey, Ann R; Losada, Cecilia; Baden, Lindsey R; Frey, Sharon E; Whitaker, Jennifer A; Little, Susan J; Anderson, Evan J; Walter, Emmanuel B; Novak, Richard M; Rupp, Richard; Jackson, Lisa A; Babu, Tara M; Kottkamp, Angelica C; Luetkemeyer, Anne F; Immergluck, Lilly C; Presti, Rachel M; Bäcker, Martín; Winokur, Patricia L; Mahgoub, Siham M; Goepfert, Paul A; Fusco, Dahlene N; Malkin, Elissa; Bethony, Jeffrey M; Walsh, Edward E; Graciaa, Daniel S; Samaha, Hady; Sherman, Amy C; Walsh, Stephen R; Abate, Getahun; Oikonomopoulou, Zacharoula; El Sahly, Hana M; Martin, Thomas C S; Kamidani, Satoshi; Smith, Michael J; Ladner, Benjamin G; Porterfield, Laura; Dunstan, Maya; Wald, Anna; Davis, Tamia; Atmar, Robert L; Mulligan, Mark J; Lyke, Kirsten E; Posavad, Christine M; Meagher, Megan A; Stephens, David S; Neuzil, Kathleen M; Abebe, Kuleni; Hill, Heather; Albert, Jim; Telu, Kalyani; Mu, Jinjian; Lewis, Teri C; Giebeig, Lisa A; Eaton, Amanda; Netzl, Antonia; Wilks, Samuel H; Türeli, Sina; Makhene, Mamodikoe; Crandon, Sonja; Montefiori, David C; Makowski, Mat; Smith, Derek J; Nayak, Seema U; Roberts, Paul C; Beigel, John H; COVAIL Study Group
Vaccine protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection wanes over time, requiring updated boosters. In a phase 2, open-label, randomized clinical trial with sequentially enrolled stages at 22 US sites, we assessed safety and immunogenicity of a second boost with monovalent or bivalent variant vaccines from mRNA and protein-based platforms targeting wild-type, Beta, Delta and Omicron BA.1 spike antigens. The primary outcome was pseudovirus neutralization titers at 50% inhibitory dilution (ID50 titers) with 95% confidence intervals against different SARS-CoV-2 strains. The secondary outcome assessed safety by solicited local and systemic adverse events (AEs), unsolicited AEs, serious AEs and AEs of special interest. Boosting with prototype/wild-type vaccines produced numerically lower ID50 titers than any variant-containing vaccine against all variants. Conversely, boosting with a variant vaccine excluding prototype was not associated with decreased neutralization against D614G. Omicron BA.1 or Beta monovalent vaccines were nearly equivalent to Omicron BA.1 + prototype or Beta + prototype bivalent vaccines for neutralization of Beta, Omicron BA.1 and Omicron BA.4/5, although they were lower for contemporaneous Omicron subvariants. Safety was similar across arms and stages and comparable to previous reports. Our study shows that updated vaccines targeting Beta or Omicron BA.1 provide broadly crossprotective neutralizing antibody responses against diverse SARS-CoV-2 variants without sacrificing immunity to the ancestral strain. registration: NCT05289037 .
PMID: 37640860
ISSN: 1546-170x
CID: 5572432

Clinical and Demographic Factors Associated With COVID-19, Severe COVID-19, and SARS-CoV-2 Infection in Adults: A Secondary Cross-Protocol Analysis of 4 Randomized Clinical Trials

Theodore, Deborah A; Branche, Angela R; Zhang, Lily; Graciaa, Daniel S; Choudhary, Madhu; Hatlen, Timothy J; Osman, Raadhiya; Babu, Tara M; Robinson, Samuel T; Gilbert, Peter B; Follmann, Dean; Janes, Holly; Kublin, James G; Baden, Lindsey R; Goepfert, Paul; Gray, Glenda E; Grinsztejn, Beatriz; Kotloff, Karen L; Gay, Cynthia L; Leav, Brett; Miller, Jacqueline; Hirsch, Ian; Sadoff, Jerald; Dunkle, Lisa M; Neuzil, Kathleen M; Corey, Lawrence; Falsey, Ann R; El Sahly, Hana M; Sobieszczyk, Magdalena E; Huang, Yunda; COVID-19 Prevention Network (CoVPN)
IMPORTANCE/UNASSIGNED:Current data identifying COVID-19 risk factors lack standardized outcomes and insufficiently control for confounders. OBJECTIVE/UNASSIGNED:To identify risk factors associated with COVID-19, severe COVID-19, and SARS-CoV-2 infection. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This secondary cross-protocol analysis included 4 multicenter, international, randomized, blinded, placebo-controlled, COVID-19 vaccine efficacy trials with harmonized protocols established by the COVID-19 Prevention Network. Individual-level data from participants randomized to receive placebo within each trial were combined and analyzed. Enrollment began July 2020 and the last data cutoff was in July 2021. Participants included adults in stable health, at risk for SARS-CoV-2, and assigned to the placebo group within each vaccine trial. Data were analyzed from April 2022 to February 2023. EXPOSURES/UNASSIGNED:Comorbid conditions, demographic factors, and SARS-CoV-2 exposure risk at the time of enrollment. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Coprimary outcomes were COVID-19 and severe COVID-19. Multivariate Cox proportional regression models estimated adjusted hazard ratios (aHRs) and 95% CIs for baseline covariates, accounting for trial, region, and calendar time. Secondary outcomes included severe COVID-19 among people with COVID-19, subclinical SARS-CoV-2 infection, and SARS-CoV-2 infection. RESULTS/UNASSIGNED:A total of 57 692 participants (median [range] age, 51 [18-95] years; 11 720 participants [20.3%] aged ≥65 years; 31 058 participants [53.8%] assigned male at birth) were included. The analysis population included 3270 American Indian or Alaska Native participants (5.7%), 7849 Black or African American participants (13.6%), 17 678 Hispanic or Latino participants (30.6%), and 40 745 White participants (70.6%). Annualized incidence was 13.9% (95% CI, 13.3%-14.4%) for COVID-19 and 2.0% (95% CI, 1.8%-2.2%) for severe COVID-19. Factors associated with increased rates of COVID-19 included workplace exposure (high vs low: aHR, 1.35 [95% CI, 1.16-1.58]; medium vs low: aHR, 1.41 [95% CI, 1.21-1.65]; P < .001) and living condition risk (very high vs low risk: aHR, 1.41 [95% CI, 1.21-1.66]; medium vs low risk: aHR, 1.19 [95% CI, 1.08-1.32]; P < .001). Factors associated with decreased rates of COVID-19 included previous SARS-CoV-2 infection (aHR, 0.13 [95% CI, 0.09-0.19]; P < .001), age 65 years or older (aHR vs age <65 years, 0.57 [95% CI, 0.50-0.64]; P < .001) and Black or African American race (aHR vs White race, 0.78 [95% CI, 0.67-0.91]; P = .002). Factors associated with increased rates of severe COVID-19 included race (American Indian or Alaska Native vs White: aHR, 2.61 [95% CI, 1.85-3.69]; multiracial vs White: aHR, 2.19 [95% CI, 1.50-3.20]; P < .001), diabetes (aHR, 1.54 [95% CI, 1.14-2.08]; P = .005) and at least 2 comorbidities (aHR vs none, 1.39 [95% CI, 1.09-1.76]; P = .008). In analyses restricted to participants who contracted COVID-19, increased severe COVID-19 rates were associated with age 65 years or older (aHR vs <65 years, 1.75 [95% CI, 1.32-2.31]; P < .001), race (American Indian or Alaska Native vs White: aHR, 1.98 [95% CI, 1.38-2.83]; Black or African American vs White: aHR, 1.49 [95% CI, 1.03-2.14]; multiracial: aHR, 1.81 [95% CI, 1.21-2.69]; overall P = .001), body mass index (aHR per 1-unit increase, 1.03 [95% CI, 1.01-1.04]; P = .001), and diabetes (aHR, 1.85 [95% CI, 1.37-2.49]; P < .001). Previous SARS-CoV-2 infection was associated with decreased severe COVID-19 rates (aHR, 0.04 [95% CI, 0.01-0.14]; P < .001). CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this secondary cross-protocol analysis of 4 randomized clinical trials, exposure and demographic factors had the strongest associations with outcomes; results could inform mitigation strategies for SARS-CoV-2 and viruses with comparable epidemiological characteristics.
PMID: 37440227
ISSN: 2574-3805
CID: 5572442

The Death of the Bedside Manner: ObamaCare is Speeding the Decline in the Quality of Medical Practice

Siegel, Marc K
PMID: 30323515
ISSN: 0026-6620
CID: 3369772

The Death of the Bedside Manner [Newspaper Article]

Siegel, Marc
[...]the veil was lifted from my eyes, and I awoke to the harsh realities of our medical future
ISSN: 0099-9660
CID: 814912

Marc Siegel: The Death of the Bedside Manner; ObamaCare is speeding the decline in the quality of medical practice. [Newspaper Article]

Siegel, Marc
[...]the veil was lifted from my eyes, and I awoke to the harsh realities of our medical future
ISSN: 0099-9660
CID: 814922

PASSAGES: Taylor Mead 1924-2013 [General Interest Article]

Siegel, Marc
If 1 begin these reflections on Taylor Mead, who died at the age of eighty-eight on May 8, 2013, with brief mention of two underexplored periods in the artist's life-his years in the late Beat scene in Venice and his European period of self-imposed exile from New York in the mid-'60s-it is to suggest that we have yet to account for the breadth, diversity, and wide-ranging importance of more than five decades of work by the disarmingly affable man considered the first superstar of underground film and the "doyen of underground performance. Rice's movie, shot on outdated 16-mm film stock that lent the black-and-white images a wistful look, was both a document of the last remnants of San Francisco's North Beach Beat scene and a lyrical portrayal of Mead's joyful embodiment of flexibility and spontaneity
ISSN: 1086-7058
CID: 814932

Best medical care comes one patient at a time [Newspaper Article]

Siegel, Marc
[...]a third of all people who experience heart attacks have no chest symptoms
ISSN: 0734-7456
CID: 814942

Required Flu Vaccines for Healthcare Workers Won't Protect Patients [Newspaper Article]

Siegel, Marc
From smallpox to polio to measles to hepatitis, modern history has shown us again and again that vaccines are one of the best medical tools we have to eradicate disease and to protect the most vulnerable populations. But recommending a vaccine strongly and mandating its use are two different things. There is simply no convincing evidence that forcing healthcare workers to be vaccinated under threat of losing their jobs cuts down on the risks of patients getting severely ill from, or dying from, the flu
ISSN: 0041-5537
CID: 814952

Surging flu no reason for vaccine mandate [Newspaper Article]

Siegel, Marc
This isn't to say that mandatory vaccines don't have their place, just that mandates should be reserved for situations where a vaccine can play a major role in fighting back a clear public health risk. In the case of seasonal flu, neither the risk of the disease nor the benefit of the vaccine is big enough to warrant forcing health care workers to receive it. Measles, another highly contagious and deadly virus, is another point of reference: Vaccination of health care workers is recommended by the CDC but not mandatory. The chances of a health care worker carrying measles isn't high enough to warrant mandatory vaccine. Instead, mandates are targeted on the most vulnerable population: children. According to the World Health Organization, increased measles vaccination resulted in a three-fourths drop in measles deaths between 2000 and 2010, when 85 percent of the world's children received one dose of the vaccine by age one, up from 72 percent in 2000
ISSN: 0739-0319
CID: 814962