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1.
Pediatrics ; 2022 May 18.
Article in English | MEDLINE | ID: covidwho-1855067

ABSTRACT

BACKGROUND AND OBJECTIVES: Limited post-authorization safety data for BNT-162b2 COVID-19 vaccination among children ages 5-11 years are available, particularly for the adverse event myocarditis, which has been detected in adolescents and young adults. We describe adverse events observed during the first 4 months of the US COVID-19 vaccination program in this age group. METHODS: We analyzed data from 3 US safety monitoring systems: v-safe, a voluntary smartphone-based system that monitors reactions and health effects; the Vaccine Adverse Events Reporting System (VAERS), the national spontaneous reporting system co-managed by CDC and FDA; and the Vaccine Safety Datalink (VSD), an active surveillance system that monitors electronic health records for prespecified events, including myocarditis. RESULTS: Among 48,795 children ages 5-11 years enrolled in v-safe, most reported reactions were mild-to-moderate, most frequently reported the day after vaccination, and were more common after dose 2. VAERS received 7,578 adverse event reports; 97% were non-serious. On review of 194 serious VAERS reports, 15 myocarditis cases were verified; 8 occurred in males after dose 2 (reporting rate 2.2 per million doses). In VSD, no safety signals were detected in weekly sequential monitoring after administration of 726,820 doses. CONCLUSIONS: Safety findings for BNT-162b2 vaccine from 3 US monitoring systems in children ages 5-11 years show that most reported adverse events were mild and no safety signals were observed in active surveillance. VAERS reporting rates of myocarditis after dose 2 in this age group were substantially lower than those observed among adolescents ages 12-15 years.

2.
Gates Open Research ; 2021.
Article in English | ProQuest Central | ID: covidwho-1835891

ABSTRACT

Background: Given that pregnant women are now included among those for receipt coronavirus disease 2019 (COVID-19) vaccines, it is important to ensure that information systems can be used (or available) for active safety surveillance, especially in low- and middle-income countries (LMICs). The aim of this study was to build consensus about the use of existing maternal and neonatal data collection systems in LMICs for COVID-19 vaccines active safety surveillance, a basic set of variables, and the suitability and feasibility of including pregnant women and LMIC research networks in COVID-19 vaccines pre-licensure activities. Methods: A three-stage modified Delphi study was conducted over three months in 2020. An international multidisciplinary panel of 16 experts participated. Ratings distributions and consensus were assessed, and ratings’ rationale was analyzed. Results: The panel recommended using maternal and neonatal data collection systems for active safety surveillance in LMICs (median 9;disagreement index [DI] -0.92), but there was no consensus (median 6;DI 1.79) on the feasibility of adapting these systems. A basic set of 14 maternal, neonatal, and vaccination-related variables. Out of 16 experts, 11 supported a basic set of 14 maternal, neonatal, and vaccination-related variables for active safety surveillance. Seven experts agreed on a broader set of 26 variables.The inclusion of pregnant women for COVID-19 vaccines research (median 8;DI -0.61) was found appropriate, although there was uncertainty on its feasibility in terms of decision-makers’ acceptability (median 7;DI 10.00) and regulatory requirements (median 6;DI 0.51). There was no consensus (median 6;DI 2.35) on the feasibility of including research networks in LMICs for conducting clinical trials amongst pregnant women. Conclusions: Although there was some uncertainty regarding feasibility, experts recommended using maternal and neonatal data collection systems and agreed on a common set of variables for COVID-19 vaccines active safety surveillance in LMICs.

3.
JAMA Netw Open ; 5(4): e228879, 2022 04 01.
Article in English | MEDLINE | ID: covidwho-1801993

ABSTRACT

Importance: Postauthorization monitoring of vaccines in a large population may detect rare adverse events not identified in clinical trials such as Guillain-Barré syndrome (GBS), which has a background rate of 1 to 2 per 100 000 person-years. Objective: To describe cases and incidence of GBS following COVID-19 vaccination and assess the risk of GBS after vaccination for Ad.26.COV2.S (Janssen) and mRNA vaccines. Design, Setting, and Participants: This cohort study used surveillance data from the Vaccine Safety Datalink at 8 participating integrated health care systems in the United States. There were 10 158 003 participants aged at least 12 years. Data analysis was performed from November 2021 to February 2022. Exposures: Ad.26.COV2.S, BNT162b2 (Pfizer-BioNTech), or mRNA-1273 (Moderna) COVID-19 vaccine, including mRNA vaccine doses 1 and 2, December 13, 2020, to November 13, 2021. Main Outcomes and Measures: GBS with symptom onset in the 1 to 84 days after vaccination, confirmed by medical record review and adjudication. Descriptive characteristics of confirmed cases, GBS incidence rates during postvaccination risk intervals after each type of vaccine compared with the background rate, rate ratios (RRs) comparing GBS incidence in the 1 to 21 vs 22 to 42 days postvaccination, and RRs directly comparing risk of GBS after Ad.26.COV2.S vs mRNA vaccination, using Poisson regression adjusted for age, sex, race and ethnicity, site, and calendar day. Results: From December 13, 2020, through November 13, 2021, 15 120 073 doses of COVID-19 vaccines were administered to 7 894 989 individuals (mean [SE] age, 46.5 [0.02] years; 8 138 318 doses received [53.8%] by female individuals; 3 671 199 doses received [24.3%] by Hispanic or Latino individuals, 2 215 064 doses received [14.7%] by Asian individuals, 6 266 424 doses received [41.4%] by White individuals), including 483 053 Ad.26.COV2.S doses, 8 806 595 BNT162b2 doses, and 5 830 425 mRNA-1273 doses. Eleven cases of GBS after Ad.26.COV2.S were confirmed. The unadjusted incidence rate of GBS per 100 000 person-years in the 1 to 21 days after Ad.26.COV2.S was 32.4 (95% CI, 14.8-61.5), significantly higher than the background rate, and the adjusted RR in the 1 to 21 vs 22 to 42 days following Ad.26.COV2.S was 6.03 (95% CI, 0.79-147.79). Thirty-six cases of GBS after mRNA vaccines were confirmed. The unadjusted incidence rate per 100 000 person-years in the 1 to 21 days after mRNA vaccines was 1.3 (95% CI, 0.7-2.4) and the adjusted RR in the 1 to 21 vs 22 to 42 days following mRNA vaccines was 0.56 (95% CI, 0.21-1.48). In a head-to-head comparison of Ad.26.COV2.S vs mRNA vaccines, the adjusted RR was 20.56 (95% CI, 6.94-64.66). Conclusions and Relevance: In this cohort study of COVID-19 vaccines, the incidence of GBS was elevated after receiving the Ad.26.COV2.S vaccine. Surveillance is ongoing.


Subject(s)
COVID-19 , Guillain-Barre Syndrome , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Cohort Studies , Female , Guillain-Barre Syndrome/epidemiology , Guillain-Barre Syndrome/etiology , Humans , Incidence , Middle Aged , United States/epidemiology , Vaccination/adverse effects , Vaccines, Synthetic
4.
Vaccine ; 40(23): 3150-3158, 2022 May 20.
Article in English | MEDLINE | ID: covidwho-1796041

ABSTRACT

BACKGROUND: The COVID-19 pandemic caused an abrupt drop in in-person health care (inpatient, Emergency Department, outpatient) and an increase in telehealth care, which poses challenges in vaccine safety studies that identify outcomes from in-person encounters. We examined the changes in incidence rates of selected encounter-based outcomes during the COVID-19 pandemic. METHODS: We assembled a cohort of members from 8 Vaccine Safety Datalink sites from January 1, 2017 through December 31, 2020. Using ICD-10 diagnosis codes or laboratory criteria, we identified 21 incident outcomes in traditional in-person settings and all settings. We defined 4 periods in 2020: January-February (pre-pandemic), April-June (early pandemic), July-September (middle pandemic), and October-December (late pandemic). We defined four corresponding periods in each year during 2017-2019. We calculated incidence rates, conducted difference in difference (DiD) analyses, and reported ratios of incidence rate ratios (RRR) to examine changes in rates from pre-pandemic to early, middle, and late pandemic in 2020, after adjusting for changes across similar periods in 2017-2019. RESULTS: Among > 10 million members, regardless of setting and after adjusting for changes during 2017-2019, we found that incidence rates of acute disseminated encephalomyelitis, encephalitis/myelitis/encephalomyelitis/meningoencephalitis, and thrombotic thrombocytopenic purpura did not significantly change from the pre-pandemic to early, middle or late pandemic periods (p-values ≥ 0.05). Incidence rates decreased from the pre-pandemic to early pandemic period during 2020 for acute myocardial infarction, anaphylaxis, appendicitis, Bell's palsy, convulsions/seizures, Guillain-Barré syndrome, immune thrombocytopenia (ITP), narcolepsy/cataplexy, hemorrhagic stroke, ischemic stroke, and venous thromboembolism (p-values < 0.05). Incidence rates of Bell's palsy, ITP, and narcolepsy/cataplexy were higher in all settings than in traditional in-person settings during the three pandemic periods (p-values < 0.05). CONCLUSION: Rates of some clinical outcomes during the pandemic changed and should not be used as historical background rates in vaccine safety studies. Inclusion of telehealth visits should be considered for vaccine studies involving Bell's palsy, ITP, and narcolepsy/cataplexy.


Subject(s)
Bell Palsy , COVID-19 , Cataplexy , Narcolepsy , Thrombocytopenia , Vaccines , COVID-19/epidemiology , COVID-19/prevention & control , Cataplexy/complications , Cataplexy/epidemiology , Humans , Incidence , Pandemics/prevention & control
5.
Vaccine ; 40(22): 3064-3071, 2022 May 11.
Article in English | MEDLINE | ID: covidwho-1778493

ABSTRACT

The Vaccine Safety Datalink (VSD) conducts active surveillance and vaccine safety research studies. Since the start of the U.S. COVID-19 vaccination program, the VSD has conducted near real-time safety surveillance of COVID-19 vaccines using Rapid Cycle Analysis. VSD investigators developed an internal dashboard to facilitate visualization and rapid reviews of large weekly automated vaccine safety surveillance data. Dashboard development and maintenance was informed by vaccine surveillance data users and vaccine safety partners. Key metrics include population demographics, vaccine uptake, pre-specified safety outcomes, sequential analyses results, and descriptive data on potential vaccine safety signals. Dashboard visualizations are used to provide situational awareness on dynamic vaccination coverage and the status of multiple safety analyses conducted among the VSD population. This report describes the development and implementation of the internal VSD COVID-19 Vaccine Dashboard, including metrics used to develop the dashboard, which may have application across various other public health settings.


Subject(s)
COVID-19 , Vaccines , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , Vaccination
6.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-319119

ABSTRACT

Background: Given that pregnant women are now included among those for receipt coronavirus disease 2019 (COVID-19) vaccines, it is important to ensure that information systems can be used (or available) for active safety surveillance, especially in low- and middle-income countries (LMICs). The aim of this study was to build consensus about the use of existing maternal and neonatal data collection systems in LMICs for COVID-19 vaccines active safety surveillance, a basic set of variables, and the suitability and feasibility of including pregnant women and LMIC research networks in COVID-19 vaccines pre-licensure activities.  Methods: A three-stage modified Delphi study was conducted over three months in 2020. An international multidisciplinary panel of 16 experts participated. Ratings distributions and consensus were assessed, and ratings’ rationale was analyzed.  Results: The panel recommended using maternal and neonatal data collection systems for active safety surveillance in LMICs (median 9;disagreement index [DI] -0.92), but there was no consensus (median 6;DI 1.79) on the feasibility of adapting these systems. A basic set of 14 maternal, neonatal, and vaccination-related variables. Out of 16 experts, 11 supported a basic set of 14 maternal, neonatal, and vaccination-related variables for active safety surveillance. Seven experts agreed on a broader set of 26 variables.The inclusion of pregnant women for COVID-19 vaccines research (median 8;DI -0.61) was found appropriate, although there was uncertainty on its feasibility in terms of decision-makers’ acceptability (median 7;DI 10.00) and regulatory requirements (median 6;DI 0.51). There was no consensus (median 6;DI 2.35) on the feasibility of including research networks in LMICs for conducting clinical trials amongst pregnant women. Conclusions: Although there was some uncertainty regarding feasibility, experts recommended using maternal and neonatal data collection systems and agreed on a common set of variables for COVID-19 vaccines active safety surveillance in LMICs.

7.
Rev Panam Salud Publica ; 45: e131, 2021.
Article in Spanish | MEDLINE | ID: covidwho-1579358

ABSTRACT

With millions of people in the world in situations of physical distancing because of COVID-19, information and communication technology (ICT) has become as one of the principal means of interaction and collaboration. The following advantages of ICT have been cited since the start of the new millennium: increased access to information and service delivery, educational strengthening, quality control of screening programs, and reduction of health care costs. In the case of telemedicine, however, a number of barriers-especially technological, human and social, psychosocial, anthropological, economic, and governance-related-have stood in the way of its adoption. The past 20 years have seen an increase in the availability of resources and technical capacity, improvements in digital education, empowerment of patients regarding their treatment, and increased public interest in this area. Successes have included the use of interdisciplinary teams, academic and professional networking, and virtual medical consultations. After reviewing the state of telemedicine in the Region of the Americas, the authors recommend the urgent adoption of measures aimed at implementing national telemedicine policies and programs, including a regulatory framework and adequate funding. Implementation of the measures should be integrated and interoperable and include the support of academic networks and the collaboration of specialized institutions. The policies should generate an enabling context that ensures sustainability of the progress achieved, bearing in mind the possible barriers mentioned.


Com milhões de pessoas no mundo em situação de distanciamento físico devido à COVID-19, as tecnologias da informação e comunicação (TICs) se enquadraram como um dos meios principais de interação e colaboração. Já no início deste milênio, começaram a ser mencionadas as seguintes vantagens: maior acesso à informação e à prestação de serviços; fortalecimento da educação; controle de qualidade dos programas de detecção e redução dos custos na atenção à saúde. No entanto, entre as principais barreiras de adoção da telemedicina se encontram as de caráter: tecnológico; humano e social; psicossocial e antropológico; de governança e econômico. Nestes 20 anos, houve um aumento nos recursos e na capacidade técnica, uma melhora na educação digital, um empoderamento do paciente em seu tratamento e um maior interesse público nessa área. Em especial, são consideradas bem-sucedidas a constituição de equipes interdisciplinares e as redes acadêmicas e profissionais, e as consultas médicas virtuais. Após revisar o estado da telemedicina na Região das Américas, os autores recomendam a adoção de medidas urgentes para implementar políticas e programas nacionais de telemedicina, incluindo o marco normativo e o orçamento necessário. Essa implementação deve ser realizada de maneira integral e interoperável e sustentada por redes acadêmicas, de parceria e instituições especializadas. Tais políticas devem gerar um contexto favorável, dando sustentabilidade ao avanço obtido e considerando os aspectos mencionados nas possíveis barreiras.

8.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-294893

ABSTRACT

Importance: Post-authorization monitoring of vaccines in a large population can detect rare adverse events not identified in clinical trials including Guillain-Barré syndrome (GBS). GBS has a background rate of 1-2 per 100,000 person-years. Objective: To 1) describe cases and incidence of GBS following COVID-19 vaccination, and 2) assess the risk of GBS after vaccination for Ad.26.COV2.S (Janssen) and mRNA vaccines. Design: Interim analysis of surveillance data from the Vaccine Safety Datalink. Setting: Eight participating integrated healthcare systems in the United States. Participants: 10,158,003 individuals aged ≥12 years. Exposures: Receipt of Ad.26.COV2.S, BNT162b2 (Pfizer-BioNTech), or mRNA-1273 (Moderna) COVID-19 vaccine. Main Outcomes and Measures: GBS with symptom onset in the 1-84 days after vaccination as confirmed by medical record review and adjudication. Descriptive characteristics of confirmed cases, GBS incidence rates during postvaccination risk intervals after each type of vaccine compared to the background rate, rate ratios (RRs) comparing GBS incidence in the 1-21 vs. 22-42 days postvaccination, and RRs directly comparing risk of GBS after Ad.26.COV2.S vs. mRNA vaccination, using Poisson regression adjusted for age, sex, race/ethnicity, site, and calendar day. Results: From December 13, 2020 through November 13, 2021, 14,723,318 doses of COVID-19 vaccines were administered, including 467,126 Ad.26.COV2.S, 8,573,823 BNT162b2, and 5,682,369 mRNA-1273 doses. Eleven cases of GBS after Ad.26.COV2.S were confirmed. The unadjusted incidence rate of confirmed cases of GBS per 100,000 person-years in the 1-21 days after Ad.26.COV2.S was 34.6 (95% confidence interval [CI]: 15.8-65.7), significantly higher than the background rate, and the adjusted RR in the 1-21 vs. 22-42 days following Ad.26.COV2.S was 6.03 (95% CI: 0.79-147.79). Thirty-four cases of GBS after mRNA vaccines were confirmed. The unadjusted incidence rate of confirmed cases per 100,000 person-years in the 1-21 days after mRNA vaccines was 1.4 (95% CI: 0.7-2.5) and the adjusted RR in the 1-21 vs. 22-42 days following mRNA vaccines was 0.56 (95% CI: 0.21-1.48). In a head-to-head comparison of Ad.26.COV2.S vs. mRNA vaccines, the adjusted RR was 20.56 (95% CI: 6.94-64.66). Conclusions and Relevance: In this interim analysis of surveillance data of COVID-19 vaccines, the incidence of GBS was elevated after Ad.26.COV2.S. Surveillance is ongoing.

9.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-293534

ABSTRACT

Importance: Post-authorization monitoring of vaccines in a large population can detect rare adverse events not identified in clinical trials including Guillain-Barré syndrome (GBS). GBS has a background rate of 1-2 per 100,000 person-years. Objective: To 1) describe cases and incidence of GBS following COVID-19 vaccination, and 2) assess the risk of GBS after vaccination for Ad.26.COV2.S (Janssen) and mRNA vaccines. Design: Interim analysis of surveillance data from the Vaccine Safety Datalink. Setting: Eight participating integrated healthcare systems in the United States. Participants: 10,158,003 individuals aged ≥12 years. Exposures: Receipt of Ad.26.COV2.S, BNT162b2 (Pfizer-BioNTech), or mRNA-1273 (Moderna) COVID-19 vaccine. Main Outcomes and Measures: GBS with symptom onset in the 1-84 days after vaccination as confirmed by medical record review and adjudication. Descriptive characteristics of confirmed cases, GBS incidence rates during postvaccination risk intervals after each type of vaccine compared to the background rate, rate ratios (RRs) comparing GBS incidence in the 1-21 vs. 22-42 days postvaccination, and RRs directly comparing risk of GBS after Ad.26.COV2.S vs. mRNA vaccination, using Poisson regression adjusted for age, sex, race/ethnicity, site, and calendar day. Results: From December 13, 2020 through November 13, 2021, 14,723,318 doses of COVID-19 vaccines were administered, including 467,126 Ad.26.COV2.S, 8,573,823 BNT162b2, and 5,682,369 mRNA-1273 doses. Eleven cases of GBS after Ad.26.COV2.S were confirmed. The unadjusted incidence rate of confirmed cases of GBS per 100,000 person-years in the 1-21 days after Ad.26.COV2.S was 34.6 (95% confidence interval [CI]: 15.8-65.7), significantly higher than the background rate, and the adjusted RR in the 1-21 vs. 22-42 days following Ad.26.COV2.S was 6.03 (95% CI: 0.79-147.79). Thirty-four cases of GBS after mRNA vaccines were confirmed. The unadjusted incidence rate of confirmed cases per 100,000 person-years in the 1-21 days after mRNA vaccines was 1.4 (95% CI: 0.7-2.5) and the adjusted RR in the 1-21 vs. 22-42 days following mRNA vaccines was 0.56 (95% CI: 0.21-1.48). In a head-to-head comparison of Ad.26.COV2.S vs. mRNA vaccines, the adjusted RR was 20.56 (95% CI: 6.94-64.66). Conclusions and Relevance: In this interim analysis of surveillance data of COVID-19 vaccines, the incidence of GBS was elevated after Ad.26.COV2.S. Surveillance is ongoing.

10.
Rev Panam Salud Publica ; 45: e131, 2021.
Article in Spanish | MEDLINE | ID: covidwho-1498313

ABSTRACT

With millions of people in the world in situations of physical distancing because of COVID-19, information and communication technology (ICT) has become as one of the principal means of interaction and collaboration. The following advantages of ICT have been cited since the start of the new millennium: increased access to information and service delivery, educational strengthening, quality control of screening programs, and reduction of health care costs. In the case of telemedicine, however, a number of barriers-especially technological, human and social, psychosocial, anthropological, economic, and governance-related-have stood in the way of its adoption. The past 20 years have seen an increase in the availability of resources and technical capacity, improvements in digital education, empowerment of patients regarding their treatment, and increased public interest in this area. Successes have included the use of interdisciplinary teams, academic and professional networking, and virtual medical consultations. After reviewing the state of telemedicine in the Region of the Americas, the authors recommend the urgent adoption of measures aimed at implementing national telemedicine policies and programs, including a regulatory framework and adequate funding. Implementation of the measures should be integrated and interoperable and include the support of academic networks and the collaboration of specialized institutions. The policies should generate an enabling context that ensures sustainability of the progress achieved, bearing in mind the possible barriers mentioned.


Com milhões de pessoas no mundo em situação de distanciamento físico devido à COVID-19, as tecnologias da informação e comunicação (TICs) se enquadraram como um dos meios principais de interação e colaboração. Já no início deste milênio, começaram a ser mencionadas as seguintes vantagens: maior acesso à informação e à prestação de serviços; fortalecimento da educação; controle de qualidade dos programas de detecção e redução dos custos na atenção à saúde. No entanto, entre as principais barreiras de adoção da telemedicina se encontram as de caráter: tecnológico; humano e social; psicossocial e antropológico; de governança e econômico. Nestes 20 anos, houve um aumento nos recursos e na capacidade técnica, uma melhora na educação digital, um empoderamento do paciente em seu tratamento e um maior interesse público nessa área. Em especial, são consideradas bem-sucedidas a constituição de equipes interdisciplinares e as redes acadêmicas e profissionais, e as consultas médicas virtuais. Após revisar o estado da telemedicina na Região das Américas, os autores recomendam a adoção de medidas urgentes para implementar políticas e programas nacionais de telemedicina, incluindo o marco normativo e o orçamento necessário. Essa implementação deve ser realizada de maneira integral e interoperável e sustentada por redes acadêmicas, de parceria e instituições especializadas. Tais políticas devem gerar um contexto favorável, dando sustentabilidade ao avanço obtido e considerando os aspectos mencionados nas possíveis barreiras.

11.
JAMA ; 326(14): 1390-1399, 2021 10 12.
Article in English | MEDLINE | ID: covidwho-1490611

ABSTRACT

Importance: Safety surveillance of vaccines against COVID-19 is critical to ensure safety, maintain trust, and inform policy. Objectives: To monitor 23 serious outcomes weekly, using comprehensive health records on a diverse population. Design, Setting, and Participants: This study represents an interim analysis of safety surveillance data from Vaccine Safety Datalink. The 10 162 227 vaccine-eligible members of 8 participating US health plans were monitored with administrative data updated weekly and supplemented with medical record review for selected outcomes from December 14, 2020, through June 26, 2021. Exposures: Receipt of BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) COVID-19 vaccination, with a risk interval of 21 days for individuals after vaccine dose 1 or 2 compared with an interval of 22 to 42 days for similar individuals after vaccine dose 1 or 2. Main Outcomes and Measures: Incidence of serious outcomes, including acute myocardial infarction, Bell palsy, cerebral venous sinus thrombosis, Guillain-Barré syndrome, myocarditis/pericarditis, pulmonary embolism, stroke, and thrombosis with thrombocytopenia syndrome. Incidence of events that occurred among vaccine recipients 1 to 21 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. For a signal, a 1-sided P < .0048 was required to keep type I error below .05 during 2 years of weekly analyses. For 4 additional outcomes, including anaphylaxis, only descriptive analyses were conducted. Results: A total of 11 845 128 doses of mRNA vaccines (57% BNT162b2; 6 175 813 first doses and 5 669 315 second doses) were administered to 6.2 million individuals (mean age, 49 years; 54% female individuals). The incidence of events per 1 000 000 person-years during the risk vs comparison intervals for ischemic stroke was 1612 vs 1781 (RR, 0.97; 95% CI, 0.87-1.08); for appendicitis, 1179 vs 1345 (RR, 0.82; 95% CI, 0.73-0.93); and for acute myocardial infarction, 935 vs 1030 (RR, 1.02; 95% CI, 0.89-1.18). No vaccine-outcome association met the prespecified requirement for a signal. Incidence of confirmed anaphylaxis was 4.8 (95% CI, 3.2-6.9) per million doses of BNT162b2 and 5.1 (95% CI, 3.3-7.6) per million doses of mRNA-1273. Conclusions and Relevance: In interim analyses of surveillance of mRNA COVID-19 vaccines, incidence of selected serious outcomes was not significantly higher 1 to 21 days postvaccination compared with 22 to 42 days postvaccination. While CIs were wide for many outcomes, surveillance is ongoing.


Subject(s)
COVID-19 Vaccines/adverse effects , Adolescent , Adult , Aged , Anaphylaxis/epidemiology , Anaphylaxis/etiology , Child , Female , Follow-Up Studies , Humans , Male , Middle Aged , Myocarditis/epidemiology , Myocarditis/etiology , Public Health Surveillance , Time Factors , Vaccines, Synthetic/adverse effects , Young Adult
12.
JAMA ; 326(14): 1390-1399, 2021 10 12.
Article in English | MEDLINE | ID: covidwho-1391514

ABSTRACT

Importance: Safety surveillance of vaccines against COVID-19 is critical to ensure safety, maintain trust, and inform policy. Objectives: To monitor 23 serious outcomes weekly, using comprehensive health records on a diverse population. Design, Setting, and Participants: This study represents an interim analysis of safety surveillance data from Vaccine Safety Datalink. The 10 162 227 vaccine-eligible members of 8 participating US health plans were monitored with administrative data updated weekly and supplemented with medical record review for selected outcomes from December 14, 2020, through June 26, 2021. Exposures: Receipt of BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) COVID-19 vaccination, with a risk interval of 21 days for individuals after vaccine dose 1 or 2 compared with an interval of 22 to 42 days for similar individuals after vaccine dose 1 or 2. Main Outcomes and Measures: Incidence of serious outcomes, including acute myocardial infarction, Bell palsy, cerebral venous sinus thrombosis, Guillain-Barré syndrome, myocarditis/pericarditis, pulmonary embolism, stroke, and thrombosis with thrombocytopenia syndrome. Incidence of events that occurred among vaccine recipients 1 to 21 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. For a signal, a 1-sided P < .0048 was required to keep type I error below .05 during 2 years of weekly analyses. For 4 additional outcomes, including anaphylaxis, only descriptive analyses were conducted. Results: A total of 11 845 128 doses of mRNA vaccines (57% BNT162b2; 6 175 813 first doses and 5 669 315 second doses) were administered to 6.2 million individuals (mean age, 49 years; 54% female individuals). The incidence of events per 1 000 000 person-years during the risk vs comparison intervals for ischemic stroke was 1612 vs 1781 (RR, 0.97; 95% CI, 0.87-1.08); for appendicitis, 1179 vs 1345 (RR, 0.82; 95% CI, 0.73-0.93); and for acute myocardial infarction, 935 vs 1030 (RR, 1.02; 95% CI, 0.89-1.18). No vaccine-outcome association met the prespecified requirement for a signal. Incidence of confirmed anaphylaxis was 4.8 (95% CI, 3.2-6.9) per million doses of BNT162b2 and 5.1 (95% CI, 3.3-7.6) per million doses of mRNA-1273. Conclusions and Relevance: In interim analyses of surveillance of mRNA COVID-19 vaccines, incidence of selected serious outcomes was not significantly higher 1 to 21 days postvaccination compared with 22 to 42 days postvaccination. While CIs were wide for many outcomes, surveillance is ongoing.


Subject(s)
COVID-19 Vaccines/adverse effects , Adolescent , Adult , Aged , Anaphylaxis/epidemiology , Anaphylaxis/etiology , Child , Female , Follow-Up Studies , Humans , Male , Middle Aged , Myocarditis/epidemiology , Myocarditis/etiology , Public Health Surveillance , Time Factors , Vaccines, Synthetic/adverse effects , Young Adult
13.
MMWR Morb Mortal Wkly Rep ; 70(24): 895-899, 2021 Jun 18.
Article in English | MEDLINE | ID: covidwho-1278794

ABSTRACT

COVID-19 vaccines are critical for ending the COVID-19 pandemic; however, current data about vaccination coverage and safety in pregnant women are limited. Pregnant women are at increased risk for severe illness and death from COVID-19 compared with nonpregnant women of reproductive age, and are at risk for adverse pregnancy outcomes, such as preterm birth (1-4). Pregnant women are eligible for and can receive any of the three COVID-19 vaccines available in the United States via Emergency Use Authorization.* Data from Vaccine Safety Datalink (VSD), a collaboration between CDC and multiple integrated health systems, were analyzed to assess receipt of ≥1 dose (first or second dose of the Pfizer-BioNTech or Moderna vaccines or a single dose of the Janssen [Johnson & Johnson] vaccine) of any COVID-19 vaccine during pregnancy, receipt of first dose of a 2-dose COVID-19 vaccine (initiation), or completion of a 1- or 2-dose COVID-19 vaccination series. During December 14, 2020-May 8, 2021, a total of 135,968 pregnant women were identified, 22,197 (16.3%) of whom had received ≥1 dose of a vaccine during pregnancy. Among these 135,968 women, 7,154 (5.3%) had initiated and 15,043 (11.1%) had completed vaccination during pregnancy. Receipt of ≥1 dose of COVID-19 vaccine during pregnancy was highest among women aged 35-49 years (22.7%) and lowest among those aged 18-24 years (5.5%), and higher among non-Hispanic Asian (Asian) (24.7%) and non-Hispanic White (White) women (19.7%) than among Hispanic (11.9%) and non-Hispanic Black (Black) women (6.0%). Vaccination coverage increased among all racial and ethnic groups over the analytic period, likely because of increased eligibility for vaccination† and increased availability of vaccine over time. These findings indicate the need for improved outreach to and engagement with pregnant women, especially those from racial and ethnic minority groups who might be at higher risk for severe health outcomes because of COVID-19 (4). In addition, providing accurate and timely information about COVID-19 vaccination to health care providers, pregnant women, and women of reproductive age can improve vaccine confidence and coverage by ensuring optimal shared clinical decision-making.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Pregnant Women , Vaccination Coverage/statistics & numerical data , Adolescent , Adult , COVID-19/epidemiology , Delivery of Health Care, Integrated , Female , Humans , Middle Aged , Pregnancy , Pregnant Women/ethnology , United States/epidemiology , Young Adult
14.
JAMA Netw Open ; 4(6): e2111182, 2021 06 01.
Article in English | MEDLINE | ID: covidwho-1258012

ABSTRACT

Importance: Information on underlying conditions and severe COVID-19 illness among children is limited. Objective: To examine the risk of severe COVID-19 illness among children associated with underlying medical conditions and medical complexity. Design, Setting, and Participants: This cross-sectional study included patients aged 18 years and younger with International Statistical Classification of Diseases, Tenth Revision, Clinical Modification code U07.1 (COVID-19) or B97.29 (other coronavirus) during an emergency department or inpatient encounter from March 2020 through January 2021. Data were collected from the Premier Healthcare Database Special COVID-19 Release, which included data from more than 800 US hospitals. Multivariable generalized linear models, controlling for patient and hospital characteristics, were used to estimate adjusted risk of severe COVID-19 illness associated with underlying medical conditions and medical complexity. Exposures: Underlying medical conditions and medical complexity (ie, presence of complex or noncomplex chronic disease). Main Outcomes and Measures: Hospitalization and severe illness when hospitalized (ie, combined outcome of intensive care unit admission, invasive mechanical ventilation, or death). Results: Among 43 465 patients with COVID-19 aged 18 years or younger, the median (interquartile range) age was 12 (4-16) years, 22 943 (52.8%) were female patients, and 12 491 (28.7%) had underlying medical conditions. The most common diagnosed conditions were asthma (4416 [10.2%]), neurodevelopmental disorders (1690 [3.9%]), anxiety and fear-related disorders (1374 [3.2%]), depressive disorders (1209 [2.8%]), and obesity (1071 [2.5%]). The strongest risk factors for hospitalization were type 1 diabetes (adjusted risk ratio [aRR], 4.60; 95% CI, 3.91-5.42) and obesity (aRR, 3.07; 95% CI, 2.66-3.54), and the strongest risk factors for severe COVID-19 illness were type 1 diabetes (aRR, 2.38; 95% CI, 2.06-2.76) and cardiac and circulatory congenital anomalies (aRR, 1.72; 95% CI, 1.48-1.99). Prematurity was a risk factor for severe COVID-19 illness among children younger than 2 years (aRR, 1.83; 95% CI, 1.47-2.29). Chronic and complex chronic disease were risk factors for hospitalization, with aRRs of 2.91 (95% CI, 2.63-3.23) and 7.86 (95% CI, 6.91-8.95), respectively, as well as for severe COVID-19 illness, with aRRs of 1.95 (95% CI, 1.69-2.26) and 2.86 (95% CI, 2.47-3.32), respectively. Conclusions and Relevance: This cross-sectional study found a higher risk of severe COVID-19 illness among children with medical complexity and certain underlying conditions, such as type 1 diabetes, cardiac and circulatory congenital anomalies, and obesity. Health care practitioners could consider the potential need for close observation and cautious clinical management of children with these conditions and COVID-19.


Subject(s)
Adolescent Health , COVID-19/epidemiology , Cardiovascular Abnormalities/epidemiology , Child Health , Diabetes Mellitus, Type 1/epidemiology , Obesity/epidemiology , Severity of Illness Index , Adolescent , COVID-19/mortality , Child , Child, Preschool , Chronic Disease , Comorbidity , Cross-Sectional Studies , Emergency Service, Hospital , Female , Hospitalization , Humans , Infant , Intensive Care Units , Male , Pandemics , Premature Birth , Respiration, Artificial , SARS-CoV-2 , United States/epidemiology
15.
MMWR Morb Mortal Wkly Rep ; 69(47): 1767-1770, 2020 Nov 27.
Article in English | MEDLINE | ID: covidwho-946410

ABSTRACT

Breastfeeding has health benefits for both infants and mothers and is recommended by numerous health and medical organizations*,† (1). The birth hospitalization is a critical period for establishing breastfeeding; however, some hospital practices, particularly related to mother-newborn contact, have given rise to concern about the potential for mother-to-newborn transmission of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (2). CDC conducted a COVID-19 survey (July 15-August 20, 2020) among 1,344 hospitals that completed the 2018 Maternity Practices in Infant Nutrition and Care (mPINC) survey to assess current practices and breastfeeding support while in the hospital. Among mothers with suspected or confirmed COVID-19, 14.0% of hospitals discouraged and 6.5% prohibited skin-to-skin care; 37.8% discouraged and 5.3% prohibited rooming-in; 20.1% discouraged direct breastfeeding but allowed it if the mother chose; and 12.7% did not support direct breastfeeding, but encouraged feeding of expressed breast milk. In response to the pandemic, 17.9% of hospitals reported reduced in-person lactation support, and 72.9% reported discharging mothers and their newborns <48 hours after birth. Some of the infection prevention and control (IPC) practices that hospitals were implementing conflicted with evidence-based care to support breastfeeding. Mothers who are separated from their newborn or not feeding directly at the breast might need additional postdischarge breastfeeding support. In addition, the American Academy of Pediatrics (AAP) recommends that newborns discharged before 48 hours receive prompt follow-up with a pediatric health care provider.


Subject(s)
Breast Feeding , Coronavirus Infections/prevention & control , Hospitals/statistics & numerical data , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Postnatal Care/organization & administration , COVID-19 , Coronavirus Infections/epidemiology , Female , Health Care Surveys , Humans , Infant, Newborn , Pneumonia, Viral/epidemiology , United States/epidemiology
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