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2.
N Engl J Med ; 386(21): e64, 2022 05 26.
Article in English | MEDLINE | ID: covidwho-1864784
3.
N Engl J Med ; 386(19): e63, 2022 05 19.
Article in English | MEDLINE | ID: covidwho-1852606
4.
N Engl J Med ; 386(19): e58, 2022 05 12.
Article in English | MEDLINE | ID: covidwho-1839601
5.
J Infect Dis ; 2022 May 10.
Article in English | MEDLINE | ID: covidwho-1831186

ABSTRACT

BACKGROUND: mRNA-1273 vaccine demonstrated 93.2% efficacy against Coronavirus disease 2019 (COVID-19) in the Coronavirus efficacy (COVE) trial. The humoral immunogenicity results are now reported. METHODS: Participants received two mRNA-1273 (100 µg) or placebo injections, 28 days apart. Immune responses were evaluated in a pre-specified, randomly-selected per-protocol immunogenicity population (n = 272 placebo; n = 1,185 mRNA-1273). Serum binding (bAb) and neutralizing (nAb) antibodies to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)-spike protein were assessed at days 1, 29, and 57 by baseline SARS-CoV-2-negative (n = 1,197) and -positive (n = 260) status, age and sex. RESULTS: SARS-CoV-2-negative vaccinees had bAb geometric mean (GM) AU/ml levels of 35,753 at day 29 that increased to 316,448 at day 57 and nAb ID50 titers of 55 at day 29 that rose to 1081 at day 57. In SARS-CoV-2-positive vacinees, the first mRNA-1273 injection elicited bAb and nAb levels that were 11-fold (410,049) and 27-fold (1,479) higher than in SARS-CoV-2-negative vaccinees, respectively, and were comparable to levels after two injections in uninfected participants. Findings were generally consistent by age and sex. CONCLUSION: mRNA-1273 elicited robust serologic immune responses across age, sex, and SARS-CoV-2-status, consistent with its high COVID-19 efficacy. Higher immune responses in those previously-infected support a booster-type effect.ClinicalTrials.gov: NCT04470427.

7.
N Engl J Med ; 386(17): e53, 2022 04 28.
Article in English | MEDLINE | ID: covidwho-1815676
8.
N Engl J Med ; 386(16): e51, 2022 Apr 21.
Article in English | MEDLINE | ID: covidwho-1805740
9.
Arthritis Rheumatol ; 74(5): e21-e36, 2022 05.
Article in English | MEDLINE | ID: covidwho-1802065

ABSTRACT

OBJECTIVE: To provide guidance to rheumatology providers on the use of COVID-19 vaccines for patients with rheumatic and musculoskeletal diseases (RMDs). METHODS: A task force was assembled that included 9 rheumatologists/immunologists, 2 infectious disease specialists, and 2 public health physicians. After agreeing on scoping questions, an evidence report was created that summarized the published literature and publicly available data regarding COVID-19 vaccine efficacy and safety, as well as literature for other vaccines in RMD patients. Task force members rated their agreement with draft consensus statements on a 9-point numerical scoring system, using a modified Delphi process and the RAND/University of California Los Angeles Appropriateness Method, with refinement and iteration over 2 sessions. Consensus was determined based on the distribution of ratings. RESULTS: Despite a paucity of direct evidence, statements were developed by the task force and agreed upon with consensus to provide guidance for use of the COVID-19 vaccines, including supplemental/booster dosing, in RMD patients and to offer recommendations regarding the use and timing of immunomodulatory therapies around the time of vaccination. CONCLUSION: These guidance statements are intended to provide direction to rheumatology health care providers on how to best use COVID-19 vaccines and to facilitate implementation of vaccination strategies for RMD patients.


Subject(s)
COVID-19 , Musculoskeletal Diseases , Rheumatic Diseases , Rheumatology , COVID-19/prevention & control , COVID-19 Vaccines/therapeutic use , Humans , Muscular Diseases , United States , Vaccination
10.
Clin Infect Dis ; 2022 Apr 18.
Article in English | MEDLINE | ID: covidwho-1795348

ABSTRACT

Vaccine clinical trials have been essential to develop effective SARS-CoV-2 vaccines. The challenges of supply chain disruptions, infection control, study designs, and participant factors that affect trial procedures are reviewed, with specific solutions to streamline the clinical trial process.

13.
N Engl J Med ; 386(14): 1361-1362, 2022 04 07.
Article in English | MEDLINE | ID: covidwho-1778675
16.
Microbiol Spectr ; 10(2): e0021122, 2022 04 27.
Article in English | MEDLINE | ID: covidwho-1752769

ABSTRACT

The use of anti-spike (S) serologic assays as surrogate measurements of SARS-CoV-2 vaccine induced immunity will be an important clinical and epidemiological tool. The characteristics of a commercially available anti-S antibody assay (Roche Elecsys anti-SARS-CoV-2 S) were evaluated in a cohort of vaccine recipients. Levels were correlated with pseudotype neutralizing antibodies (NAb) across SARS-CoV-2 variants. We recruited adults receiving a two-dose series of mRNA-1273 or BNT162b2 and collected serum at scheduled intervals up to 8 months post-first vaccination. Anti-S and NAb levels were measured, and correlation was evaluated by (i) vaccine type and (ii) SARS-CoV-2 variant (wild-type, Alpha, Beta, Gamma, and three constructs Day 146*, Day 152*, and RBM-2). Forty-six mRNA vaccine recipients were enrolled. mRNA-1273 vaccine recipients had higher peak anti-S and NAb levels compared with BNT162b2 (P < 0.001 for anti-S levels; P < 0.05 for NAb levels). When anti-S and NAb levels were compared, there was good correlation (all r values ≥ 0.85) in both BNT162b2 and mRNA-1273 vaccine recipients across all evaluated variants; however, these correlations were nonlinear in nature. Lower correlation was identified between anti-S and NAb for the Beta variant (r = 0.88) compared with the wild-type (WT) strain (r = 0.94). Finally, the degree of neutralizing activity at any given anti-S level was lower for each variant compared with that of the WT strain, (P < 0.001). Although the Roche anti-S assay correlates well with NAb levels, this association is affected by vaccine type and SARS-CoV-2 variant. These variables must be considered when interpreting anti-S levels. IMPORTANCE We evaluated anti-spike antibody concentrations in healthy mRNA vaccinated individuals and compared these concentrations to values obtained from pseudotype neutralization assays targeting SARS-CoV-2 variants of concern to determine how well anti-spike antibodies correlate with neutralizing titers, which have been used as a marker of immunity from COVID-19 infection. We found high peak anti-spike concentrations in these individuals, with significantly higher levels seen in mRNA-1273 vaccine recipients. When we compared anti-spike and pseudotype neuralization titers, we identified good correlation; however, this correlation was affected by both vaccine type and variant, illustrating the difficulty of applying a "one size fits all" approach to anti-spike result interpretation. Our results support CDC recommendations to discourage anti-spike antibody testing to assess for immunity after vaccination and cautions providers in their interpretations of these results as a surrogate of protection in COVID-vaccinated individuals.


Subject(s)
COVID-19 , SARS-CoV-2 , Adult , Antibodies, Neutralizing , Antibodies, Viral , COVID-19/diagnosis , COVID-19/prevention & control , COVID-19 Vaccines , Humans , SARS-CoV-2/genetics , Vaccines, Synthetic
20.
Vaccines (Basel) ; 10(2)2022 Jan 27.
Article in English | MEDLINE | ID: covidwho-1715825

ABSTRACT

While the development of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines was rapid, time to development and implementation challenges remain that may impact the response to future pandemics. Trained immunity via bacille Calmette-Guerin (BCG) vaccination (an antigen agnostic strategy) offers a potential intervention against future novel pathogens via an existing, safe, and widely distributed vaccine to protect vulnerable populations and preserve health system capacity while targeted vaccines are developed and implemented.

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