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1.
MMWR Morb Mortal Wkly Rep ; 70(5152): 1755-1760, 2021 Dec 31.
Article in English | MEDLINE | ID: covidwho-1593989

ABSTRACT

On October 29, 2021, the Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 (BNT162b2) mRNA vaccine to expand its use to children aged 5-11 years, administered as 2 doses (10 µg, 0.2mL each) 3 weeks apart (1). As of December 19, 2021, only the Pfizer-BioNTech COVID-19 vaccine is authorized for administration to children aged 5-17 years (2,3). In preauthorization clinical trials, Pfizer-BioNTech COVID-19 vaccine was administered to 3,109 children aged 5-11 years; most adverse events were mild to moderate, and no serious adverse events related to vaccination were reported (4). To further characterize safety of the vaccine in children aged 5-11 years, CDC reviewed adverse events after receipt of Pfizer-BioNTech COVID-19 vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety surveillance system co-managed by CDC and FDA, and adverse events and health impact assessments reported to v-safe, a voluntary smartphone-based safety surveillance system for adverse events after COVID-19 vaccination,* during November 3-December 19, 2021. Approximately 8.7 million doses of Pfizer-BioNTech COVID-19 vaccine were administered to children aged 5-11 years† during this period; VAERS received 4,249 reports of adverse events after vaccination with Pfizer-BioNTech COVID-19 vaccine in this age group, 4,149 (97.6%) of which were not serious. Approximately 42,504 children aged 5-11 years were enrolled in v-safe after vaccination with Pfizer-BioNTech COVID-19 vaccine; after dose 2, a total of 17,180 (57.5%) local and 12,223 systemic (40.9%) reactions (including injection-site pain, fatigue, or headache) were reported. The preliminary safety findings are similar to those from preauthorization clinical trials (4,5). The Advisory Committee on Immunization Practices (ACIP) recommends the Pfizer-BioNTech COVID-19 vaccine for children aged 5-11 years for the prevention of COVID-19 (6). Parents and guardians of children aged 5-11 years vaccinated with Pfizer-BioNTech COVID-19 vaccine should be advised that local and systemic reactions are expected after vaccination. Vaccination is the most effective way to prevent COVID-19. CDC and FDA will continue to monitor vaccine safety and will provide updates as needed to guide COVID-19 vaccination recommendations.


Subject(s)
COVID-19 Vaccines/adverse effects , Child , Child, Preschool , Female , Humans , Male , United States
2.
Neurol Neuroimmunol Neuroinflamm ; 9(1)2022 01.
Article in English | MEDLINE | ID: covidwho-1591928

ABSTRACT

BACKGROUND AND OBJECTIVES: There are limited data on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine reactogenicity in persons with multiple sclerosis (PwMS) and how reactogenicity is affected by disease-modifying therapies (DMTs). The objective of this retrospective cross-sectional study was to generate real-world multiple sclerosis-specific vaccine safety information, particularly in the context of specific DMTs, and provide information to mitigate specific concerns in vaccine hesitant PwMS. METHODS: Between 3/2021 and 6/2021, participants in iConquerMS, an online people-powered research network, reported SARS-CoV-2 vaccines, experiences of local (itch, pain, redness, swelling, or warmth at injection site) and systemic (fever, chills, fatigue, headache, joint pain, malaise, muscle ache, nausea, allergic, and other) reactions within 24 hours (none, mild, moderate, and severe), DMT use, and other attributes. Multivariable models characterized associations between clinical factors and reactogenicity. RESULTS: In 719 PwMS, 64% reported experiencing a reaction after their first vaccination shot, and 17% reported a severe reaction. The most common reactions were pain at injection site (54%), fatigue (34%), headache (28%), and malaise (21%). Younger age, being female, prior SARS-CoV-2 infection, and receiving the ChAdOx1 nCoV-19 (Oxford-AstraZeneca) vs BNT162b2 (Pfizer-BioNTech) vaccine were associated with experiencing a reaction after the first vaccine dose. Similar relationships were observed for a severe reaction, including higher odds of reactions among PwMS with more physical impairment and lower odds of reactions for PwMS on an alpha4-integrin blocker or sphingosine-1-phosphate receptor modulator. In 442 PwMS who received their second vaccination shot, 74% reported experiencing a reaction, whereas 22% reported a severe reaction. Reaction profiles after the second shot were similar to those reported after the first shot. Younger PwMS and those who received the mRNA-1273 (Moderna) vs BNT162b2 vaccine reported higher reactogenicity after the second shot, whereas those on a sphingosine-1-phosphate receptor modulator or fumarate were significantly less likely to report a reaction. DISCUSSION: SARS-CoV-2 vaccine reactogenicity profiles and the associated factors in this convenience sample of PwMS appear similar to those reported in the general population. PwMS on specific DMTs were less likely to report vaccine reactions. Overall, the short-term vaccine reactions experienced in the study population were mostly self-limiting, including pain at the injection site, fatigue, headache, and fever.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/immunology , COVID-19/complications , COVID-19/immunology , Immunogenicity, Vaccine/immunology , Multiple Sclerosis/complications , Multiple Sclerosis/immunology , Adult , Aged , COVID-19/prevention & control , COVID-19/virology , Cross-Sectional Studies , Female , Humans , Immunization, Secondary/adverse effects , Internet , Male , Middle Aged , Multiple Sclerosis/virology , Retrospective Studies , SARS-CoV-2/immunology , SARS-CoV-2/pathogenicity , Surveys and Questionnaires , Vaccination/adverse effects , Vaccination/statistics & numerical data
10.
BMJ ; 375: e068665, 2021 12 16.
Article in English | MEDLINE | ID: covidwho-1583188

ABSTRACT

OBJECTIVE: To investigate the association between SARS-CoV-2 vaccination and myocarditis or myopericarditis. DESIGN: Population based cohort study. SETTING: Denmark. PARTICIPANTS: 4 931 775 individuals aged 12 years or older, followed from 1 October 2020 to 5 October 2021. MAIN OUTCOME MEASURES: The primary outcome, myocarditis or myopericarditis, was defined as a combination of a hospital diagnosis of myocarditis or pericarditis, increased troponin levels, and a hospital stay lasting more than 24 hours. Follow-up time before vaccination was compared with follow-up time 0-28 days from the day of vaccination for both first and second doses, using Cox proportional hazards regression with age as an underlying timescale to estimate hazard ratios adjusted for sex, comorbidities, and other potential confounders. RESULTS: During follow-up, 269 participants developed myocarditis or myopericarditis, of whom 108 (40%) were 12-39 years old and 196 (73%) were male. Of 3 482 295 individuals vaccinated with BNT162b2 (Pfizer-BioNTech), 48 developed myocarditis or myopericarditis within 28 days from the vaccination date compared with unvaccinated individuals (adjusted hazard ratio 1.34 (95% confidence interval 0.90 to 2.00); absolute rate 1.4 per 100 000 vaccinated individuals within 28 days of vaccination (95% confidence interval 1.0 to 1.8)). Adjusted hazard ratios among female participants only and male participants only were 3.73 (1.82 to 7.65) and 0.82 (0.50 to 1.34), respectively, with corresponding absolute rates of 1.3 (0.8 to 1.9) and 1.5 (1.0 to 2.2) per 100 000 vaccinated individuals within 28 days of vaccination, respectively. The adjusted hazard ratio among 12-39 year olds was 1.48 (0.74 to 2.98) and the absolute rate was 1.6 (1.0 to 2.6) per 100 000 vaccinated individuals within 28 days of vaccination. Among 498 814 individuals vaccinated with mRNA-1273 (Moderna), 21 developed myocarditis or myopericarditis within 28 days from vaccination date (adjusted hazard ratio 3.92 (2.30 to 6.68); absolute rate 4.2 per 100 000 vaccinated individuals within 28 days of vaccination (2.6 to 6.4)). Adjusted hazard ratios among women only and men only were 6.33 (2.11 to 18.96) and 3.22 (1.75 to 5.93), respectively, with corresponding absolute rates of 2.0 (0.7 to 4.8) and 6.3 (3.6 to 10.2) per 100 000 vaccinated individuals within 28 days of vaccination, respectively. The adjusted hazard ratio among 12-39 year olds was 5.24 (2.47 to 11.12) and the absolute rate was 5.7 (3.3 to 9.3) per 100 000 vaccinated individuals within 28 days of vaccination. CONCLUSIONS: Vaccination with mRNA-1273 was associated with a significantly increased risk of myocarditis or myopericarditis in the Danish population, primarily driven by an increased risk among individuals aged 12-39 years, while BNT162b2 vaccination was only associated with a significantly increased risk among women. However, the absolute rate of myocarditis or myopericarditis after SARS-CoV-2 mRNA vaccination was low, even in younger age groups. The benefits of SARS-CoV-2 mRNA vaccination should be taken into account when interpreting these findings. Larger multinational studies are needed to further investigate the risks of myocarditis or myopericarditis after vaccination within smaller subgroups.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Myocarditis/etiology , Pericarditis/etiology , Vaccination/adverse effects , /adverse effects , Adolescent , Adult , Aged , COVID-19 Vaccines/administration & dosage , Child , Cohort Studies , Denmark/epidemiology , Female , Humans , Length of Stay/statistics & numerical data , Male , Middle Aged , Myocarditis/epidemiology , Pericarditis/epidemiology , SARS-CoV-2 , Troponin/blood , Young Adult
12.
BMC Cancer ; 21(1): 1354, 2021 Dec 27.
Article in English | MEDLINE | ID: covidwho-1582093

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)
/administration & dosage , Antibodies, Viral/blood , COVID-19/prevention & control , Immunization Schedule , Multiple Myeloma/blood , /adverse effects , Aged , 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 , Vaccines, Synthetic/administration & dosage , Vaccines, Synthetic/adverse effects , /adverse effects
13.
Front Immunol ; 12: 758294, 2021.
Article in English | MEDLINE | ID: covidwho-1581342

ABSTRACT

Objective: This meta-analysis compared the efficacy and safety of five kinds of COVID-19 vaccines in different age groups (young adults and older adults), aiming to analyze the difference of adverse events (AEs) rate and virus geometric mean titer (GMT) values between young and older people, in order to find a specific trend, and explore the causes of this trend through meta-analysis. Method: Meta-analysis was used to analyze the five eligible articles. The modified Jadad scoring scale was used to evaluate the quality of eligible literature with a scoring system of 1 to 7. The primary endpoint of the effectiveness index was GMT. The primary endpoints of the safety index were the incidence of local AEs and systemic AEs. Stata 12.0 software was used for meta-analysis. Revman 5.0 software was used to map the risk of publication bias, and Egger's test was used to analyze publication bias. Results: The GMT values of young adults were higher than older adults (SMD = 1.40, 95% CI (0.79, 2.02), P<0.01). There was a higher incidence of local and systemic AEs in young people than in the elderly (OR = 1.10, 95% CI (1.08, 1.12), P<0.01; OR = 1.18, 95% CI (1.14, 1.22), P<0.01). Conclusion: The immune effect of young people after being vaccinated with COVID-19 vaccines was better than that of the elderly, but the safety was worse than that of old people, the most common AEs were fever, rash, and local muscle pain, which were tolerable for young people. As the AEs of the elderly were lower, they can also be vaccinated safely; the reason for the low level of GMT in the elderly was related to Immunosenescence. The vaccine tolerance of people of different ages needs to be studied continuously.


Subject(s)
Antibodies, Viral/blood , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/immunology , COVID-19/prevention & control , Immunogenicity, Vaccine , Adult , Age Factors , Aged , Aged, 80 and over , Antibodies, Neutralizing/blood , Female , Humans , Male , Middle Aged , SARS-CoV-2
14.
Cells ; 10(12)2021 12 18.
Article in English | MEDLINE | ID: covidwho-1580999

ABSTRACT

Atypical hemolytic uremic syndrome (aHUS) is a rare disorder characterized by dysregulation of the alternate pathway. The diagnosis of aHUS is one of exclusion, which complicates its early detection and corresponding intervention to mitigate its high rate of mortality and associated morbidity. Heterozygous mutations in complement regulatory proteins linked to aHUS are not always phenotypically active, and may require a particular trigger for the disease to manifest. This list of triggers continues to expand as more data is aggregated, particularly centered around COVID-19 and pediatric vaccinations. Novel genetic mutations continue to be identified though advancements in technology as well as greater access to cohorts of interest, as in diacylglycerol kinase epsilon (DGKE). DGKE mutations associated with aHUS are the first non-complement regulatory proteins associated with the disease, drastically changing the established framework. Additional markers that are less understood, but continue to be acknowledged, include the unique autoantibodies to complement factor H and complement factor I which are pathogenic drivers in aHUS. Interventional therapeutics have undergone the most advancements, as pharmacokinetic and pharmacodynamic properties are modified as needed in addition to their as biosimilar counterparts. As data continues to be gathered in this field, future advancements will optimally decrease the mortality and morbidity of this disease in children.


Subject(s)
Atypical Hemolytic Uremic Syndrome/genetics , Complement Factor H/genetics , Complement Factor I/genetics , Diacylglycerol Kinase/genetics , Mutation , Atypical Hemolytic Uremic Syndrome/drug therapy , Atypical Hemolytic Uremic Syndrome/immunology , Autoantibodies/immunology , COVID-19/drug therapy , COVID-19/genetics , COVID-19/immunology , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/immunology , COVID-19 Vaccines/therapeutic use , Child , Complement Factor H/immunology , Complement Factor I/immunology , Diacylglycerol Kinase/immunology , Humans , SARS-CoV-2/genetics , SARS-CoV-2/immunology
16.
Clin Appl Thromb Hemost ; 27: 10760296211068487, 2021.
Article in English | MEDLINE | ID: covidwho-1575876

ABSTRACT

BACKGROUND: Cases of thrombosis with thrombocytopenia syndrome (TTS) have been reported following vaccination with AZD1222 or Ad26.COV2.S. This review aimed to explore the pathophysiology, epidemiology, diagnosis, management, and prognosis of TTS. METHODS: A systematic review was conducted to identify evidence on TTS till 4th September 2021. Case reports and series reporting patient-level data were included. Descriptive statistics were reported and compared across patients with different sexes, age groups, vaccines, types of thrombosis, and outcomes. FINDINGS: Sixty-two studies reporting 160 cases were included from 16 countries. Patients were predominantly females with a median age of 42.50 (22) years. AZD1222 was administered to 140 patients (87·5%). TTS onset occurred in a median of 9 (4) days after vaccination. Venous thrombosis was most common (61.0%). Most patients developed cerebral venous sinus thrombosis (CVST; 66.3%). CVST was significantly more common in female vs male patients (p = 0·001) and in patients aged <45 years vs ≥45 years (p = 0·004). The mortality rate was 36.2%, and patients with suspected TTS, venous thrombosis, CVST, pulmonary embolism, or intraneural complications, patients not managed with non-heparin anticoagulants or IVIG, patients receiving platelet transfusions, and patients requiring intensive care unit admission, mechanical ventilation, or inpatient neurosurgery were more likely to expire than recover. INTERPRETATION: These findings help to understand the pathophysiology of TTS while also recommending diagnostic and management approaches to improve prognosis in patients. FUNDING: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.


Subject(s)
COVID-19 Vaccines/adverse effects , Thrombocytopenia/chemically induced , Thrombosis/chemically induced , Adult , Aged , Female , Humans , Male , Middle Aged , Syndrome
19.
Int J Immunopathol Pharmacol ; 35: 20587384211065628, 2021.
Article in English | MEDLINE | ID: covidwho-1574616

ABSTRACT

OBJECTIVES: Vaccination rollout against COVID-19 has started in developed countries in early December 2020. Mass immunization for poor or low-income countries is quite challenging before 2023. Being a lower-middle-income country, Bangladesh has begun a nationwide COVID-19 vaccination drive in early February 2021. Here, we aimed to assess the opinions, experiences, and adverse events of the COVID-19 vaccination in Bangladesh. METHODS: We conducted this online cross-sectional study from 10 February 2021, to 10 March 2021, in Bangladesh. A self-reported semi-structured survey questionnaire was used using Google forms. We recorded demographics, disease history, medication records, opinions and experiences of vaccination, and associated adverse events symptoms. RESULTS: We observed leading comorbid diseases were hypertension (25.9%), diabetes (21.1%), heart diseases (9.3%), and asthma (8.7%). The most frequently reported adverse events were injection site pain (34.3%), fever (32.6%), headache (20.2%), fatigue (16.6%), and cold feeling (15.4%). The chances of having adverse events were significantly higher in males than females (p = 0.039). However, 36.4% of respondents reported no adverse events. Adverse events usually appeared after 12 h and went way within 48 h of vaccination. Besides, 85.5% were happy with the overall vaccination management, while 88.0% of the respondents recommended the COVID-19 vaccine for others for early immunization. CONCLUSION: According to the present findings, reported adverse events after the doses of Covishield in Bangladesh were non-serious and temporary. In Bangladesh, the early vaccination against COVID-19 was possible due to its prudent vaccine deal, previous mass vaccination experience, and vaccine diplomacy.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Mass Vaccination , Adult , Bangladesh/epidemiology , COVID-19/epidemiology , COVID-19/immunology , COVID-19 Vaccines/adverse effects , Comorbidity , Cross-Sectional Studies , Developing Countries , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Humans , Male , Mass Vaccination/adverse effects , Middle Aged , Patient Satisfaction , Program Evaluation , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , Young Adult
20.
J Laryngol Otol ; 135(11): 1025-1030, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1569188

ABSTRACT

OBJECTIVE: Patients with coronavirus disease vaccine associated lymphadenopathy are increasingly being referred to healthcare services. This work is the first to report on the incidence, clinical course and imaging features of coronavirus disease vaccine associated cervical lymphadenopathy, with special emphasis on the implications for head and neck cancer services. METHODS: This was a retrospective cohort study of all patients referred to our head and neck cancer clinics between 16 December 2020 and 12 March 2021. The main outcomes measured were the proportion of patients with vaccine-associated cervical lymphadenopathy, and the clinical and imaging characteristics. RESULTS: The incidence of vaccine-associated cervical lymphadenopathy referrals was 14.8 per cent (n = 13). Five patients (38.5 per cent) had abnormal-looking enlarged and rounded nodes with increased vascularity. Only seven patients (53.9 per cent) reported full resolution within an average of 3.1 ± 2.3 weeks. CONCLUSION: Coronavirus disease vaccine associated cervical lymphadenopathy can mimic malignant lymphadenopathy and therefore might prove challenging to diagnose and manage correctly. Healthcare services may encounter a significant increase in referrals.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Head and Neck Neoplasms/immunology , Lymphadenopathy/chemically induced , Lymphadenopathy/epidemiology , Adult , Aged , Aged, 80 and over , Female , Head and Neck Neoplasms/virology , Humans , Incidence , Male , Middle Aged , Neck/pathology , Neck/virology , Retrospective Studies , SARS-CoV-2
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