ABSTRACT
BACKGROUND: Patients with multiple myeloma (MM) were excluded from the original SARS-CoV-2 mRNA vaccine trials, which may influence vaccine hesitancy in this population. We prospectively characterized the safety and immunogenicity of two-dose SARS-CoV-2 mRNA vaccination in 44 patients with MM, who underwent vaccination from 12/17/2020 to 3/18/2021. RESULTS: Rates adverse reactions were low and consistent with those documented in vaccine trials. Among those on MM therapy, 93% developed detectable anti-receptor binding domain (RBD) antibodies after dose 2, while 94% of patients not on MM therapy seroconverted. CONCLUSIONS: Two-dose SARS-CoV-2 mRNA vaccination is mildly reactogenic and leads to high rates of seroconversion in patients with MM. These findings can provide reassurance to MM patients who are hesitant to receive SARS-CoV-2 mRNA vaccines.
Subject(s)
2019-nCoV Vaccine mRNA-1273/administration & dosage , Antibodies, Viral/blood , BNT162 Vaccine/administration & dosage , COVID-19/prevention & control , Immunization Schedule , Multiple Myeloma/blood , 2019-nCoV Vaccine mRNA-1273/adverse effects , Aged , BNT162 Vaccine/adverse effects , COVID-19/epidemiology , COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/adverse effects , Cohort Studies , Female , Humans , Male , Middle Aged , Multiple Myeloma/epidemiology , Prospective Studies , Vaccination Hesitancy , Vaccines, Synthetic/administration & dosage , Vaccines, Synthetic/adverse effects , mRNA Vaccines/administration & dosage , mRNA Vaccines/adverse effectsSubject(s)
COVID-19 Vaccines/immunology , COVID-19/prevention & control , Immunity, Humoral/drug effects , Musculoskeletal Diseases/immunology , Mycophenolic Acid/administration & dosage , Rheumatic Diseases/immunology , Withholding Treatment , Adult , Aged , Antibodies, Viral/blood , Antibodies, Viral/immunology , COVID-19/immunology , Female , Humans , Male , Middle Aged , Musculoskeletal Diseases/drug therapy , Musculoskeletal Diseases/virology , Mycophenolic Acid/immunology , Prospective Studies , Rheumatic Diseases/drug therapy , Rheumatic Diseases/virology , SARS-CoV-2/immunology , Young AdultSubject(s)
Antibodies, Viral/blood , COVID-19 Vaccines/immunology , COVID-19/prevention & control , Immunocompromised Host , Musculoskeletal Diseases/immunology , Rheumatic Diseases/immunology , 2019-nCoV Vaccine mRNA-1273 , Adult , BNT162 Vaccine , Female , Humans , Male , Middle Aged , Prospective Studies , Risk Factors , SARS-CoV-2/immunology , Spike Glycoprotein, Coronavirus/immunology , Young AdultSubject(s)
COVID-19 , Musculoskeletal Diseases , Antibody Formation , COVID-19 Vaccines , Humans , SARS-CoV-2ABSTRACT
In this study of 12 people with HIV (PWH) who received the first dose of SARS-CoV-2 mRNA vaccination, anti-SARS-CoV-2 receptor-binding domain antibodies were detectable in all participants; lower antibody levels were seen in those with lower CD4+ counts, and vaccine reactions were generally mild.
Subject(s)
COVID-19 , HIV Infections , Vaccines , Antibodies, Neutralizing , Antibodies, Viral , Antibody Formation , Humans , RNA, Messenger , SARS-CoV-2ABSTRACT
OBJECTIVE: To evaluate disease flare and postvaccination reactions (reactogenicity) in patients with rheumatic and musculoskeletal diseases (RMDs) following 2-dose SARS-CoV-2 messenger RNA (mRNA) vaccination. METHODS: RMD patients (n = 1,377) who received 2-dose SARS-CoV-2 mRNA vaccination between December 16, 2020 and April 15, 2021 completed questionnaires detailing local and systemic reactions experienced within 7 days of each vaccine dose (dose 1 and dose 2), and 1 month after dose 2, detailing any flares of RMD. Associations between demographic/clinical characteristics and flares requiring treatment were evaluated using modified Poisson regression. RESULTS: Among the patients, 11% reported flares requiring treatment; there were no reports of severe flares. Flares were associated with prior SARS-CoV-2 infection (incidence rate ratio [IRR] 2.09, P = 0.02), flares in the 6 months preceding vaccination (IRR 2.36, P < 0.001), and the use of combination immunomodulatory therapy (IRR 1.95, P < 0.001). The most frequently reported local and systemic reactions included injection site pain (87% after dose 1, 86% after dose 2) and fatigue (60% after dose 1, 80% after dose 2). Reactogenicity increased after dose 2, particularly for systemic reactions. No allergic reactions or SARS-CoV-2 diagnoses were reported. CONCLUSION: Flares of underlying RMD following SARS-CoV-2 vaccination were uncommon. There were no reports of severe flares. Local and systemic reactions typically did not interfere with daily activity. These early safety data can help address vaccine hesitancy in RMD patients.
Subject(s)
2019-nCoV Vaccine mRNA-1273/adverse effects , BNT162 Vaccine/adverse effects , COVID-19/prevention & control , Musculoskeletal Diseases/immunology , Rheumatic Diseases/immunology , 2019-nCoV Vaccine mRNA-1273/administration & dosage , Adult , BNT162 Vaccine/administration & dosage , COVID-19/immunology , Female , Humans , Male , Middle Aged , Prospective Studies , SARS-CoV-2/immunology , Symptom Flare UpABSTRACT
This study of SARS-CoV-2 mRNA vaccination in 14 persons with HIV (PWH) demonstrated uniformly high anti-SARS-CoV-2 receptor binding domain (RBD) antibody titres after two doses, despite varied titres after a single dose. The majority of vaccine reactions were mild and no adverse events occurred.
Subject(s)
COVID-19 , HIV Infections , Antibodies, Viral , Antibody Formation , Humans , RNA, Messenger , SARS-CoV-2 , VaccinationSubject(s)
COVID-19/prevention & control , Immunocompromised Host/immunology , Immunogenicity, Vaccine/immunology , Rheumatic Diseases/immunology , Adult , Aged , Antibodies, Viral/blood , Antibodies, Viral/immunology , Antirheumatic Agents/therapeutic use , Female , Humans , Immunogenicity, Vaccine/drug effects , Male , Middle Aged , Rheumatic Diseases/drug therapy , SARS-CoV-2ABSTRACT
BACKGROUND: We studied the safety and reactogenicity SARS-CoV-2 mRNA vaccines in transplant recipients because immunosuppressed patients were excluded from vaccine trials. METHODS: US transplant recipients were recruited into this prospective cohort study through social media; those who completed the full vaccine series between December 9, 2020 and March 1, 2021 were included. We collected demographics, medical history, and safety information within 7 d after doses 1 and 2 (D1, D2). Associations between characteristics and reactions were evaluated using modified Poisson regression. RESULTS: We studied 741 transplant recipients who underwent BNT162b2 (54%) or mRNA-1273 (46%) vaccination. Median (interquartile range) age was 60 (44-69) y, 57% were female, and 10% were non-White. Although local site reactions decreased after D2 (85% D1 versus 78% D2, P < 0.001), systemic reactions increased (49% D1 versus 69% D2, P < 0.001). Younger participants were more likely to develop systemic symptoms after D1 (adjusted incidence rate ratio [aIRR] per 10 y = 0.850.900.94, P < 0.001) and D2 (aIRR per 10 y = 0.910.930.96, P < 0.001). Participants who experienced pain (aIRR = 1.111.662.47, P = 0.01) or redness (aIRR = 1.833.928.41, P < 0.01) were more likely to develop an antibody response to D1 of mRNA vaccines. No anaphylaxis, neurologic diagnoses, or SARS-CoV-2 diagnoses were reported. Infections were minimal (3% after D1, <0.01% after D2). One patient reported incident acute rejection post-D2. CONCLUSIONS: In solid organ transplant recipients undergoing mRNA vaccination, reactogenicity was similar to that reported in the original trials. Severe reactions were rare. These early safety data may help address vaccine hesitancy in transplant recipients.