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1.
Vaccine ; 2024 Feb 09.
Artigo em Inglês | MEDLINE | ID: mdl-38341293

RESUMO

During the COVID-19 pandemic, candidate COVID-19 vaccines were being developed for potential use in the United States on an unprecedented, accelerated schedule. It was anticipated that once available, under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or FDA approval, COVID-19 vaccines would be broadly used and potentially administered to millions of individuals in a short period of time. Intensive monitoring in the post-EUA/licensure period would be necessary for timely detection and assessment of potential safety concerns. To address this, the Centers for Disease Control and Prevention (CDC) convened an Advisory Committee on Immunization Practices (ACIP) work group focused solely on COVID-19 vaccine safety, consisting of independent vaccine safety experts and representatives from federal agencies - the ACIP COVID-19 Vaccine Safety Technical Work Group (VaST). This report provides an overview of the organization and activities of VaST, summarizes data reviewed as part of the comprehensive effort to monitor vaccine safety during the COVID-19 pandemic, and highlights selected actions taken by CDC, ACIP, and FDA in response to accumulating post-authorization safety data. VaST convened regular meetings over the course of 29 months, from November 2020 through April 2023; through March 2023 FDA issued EUAs for six COVID-19 vaccines from four different manufacturers and subsequently licensed two of these COVID-19 vaccines. The independent vaccine safety experts collaborated with federal agencies to ensure timely assessment of vaccine safety data during this time. VaST worked closely with the ACIP COVID-19 Vaccines Work Group; that work group used safety data and VaST's assessments for benefit-risk assessments and guidance for COVID-19 vaccination policy. Safety topics reviewed by VaST included those identified in safety monitoring systems and other topics of scientific or public interest. VaST provided guidance to CDC's COVID-19 vaccine safety monitoring efforts, provided a forum for review of data from several U.S. government vaccine safety systems, and assured that a diverse group of scientists and clinicians, external to the federal government, promptly reviewed vaccine safety data. In the event of a future pandemic or other biological public health emergency, the VaST model could be used to strengthen vaccine safety monitoring, enhance public confidence, and increase transparency through incorporation of independent, non-government safety experts into the monitoring process, and through strong collaboration among federal and other partners.

2.
MMWR Morb Mortal Wkly Rep ; 73(1): 6-10, 2024 Jan 11.
Artigo em Inglês | MEDLINE | ID: mdl-38206855

RESUMO

At its October 2023 meeting, the Advisory Committee on Immunization Practices* (ACIP) approved the Recommended Child and Adolescent Immunization Schedule for Ages 18 Years or Younger, United States, 2024. The child and adolescent immunization schedule, which can be found on the CDC immunization schedule website (https://www.cdc.gov/vaccines/schedules), is published annually to consolidate and summarize updates to ACIP recommendations on the vaccination of children and adolescents and to assist health care providers in implementing current ACIP recommendations. The 2024 immunization schedule includes several changes to the cover page, tables, notes, and appendix from the 2023 immunization schedule.† In addition, the 2024 child and adolescent immunization schedule includes a new addendum section to summarize new or updated ACIP recommendations that will occur before the next annual update to the child and adolescent immunization schedule. Health care providers are advised to use the cover page, tables, notes, appendix, and addendum together to identify the recommended immunizations for patient populations.


Assuntos
Comitês Consultivos , Imunização , Adolescente , Criança , Humanos , Lactente , Centers for Disease Control and Prevention, U.S. , Esquemas de Imunização , Estados Unidos , Vacinação
4.
MMWR Morb Mortal Wkly Rep ; 73(1): 11-15, 2024 Jan 11.
Artigo em Inglês | MEDLINE | ID: mdl-38206880

RESUMO

At its October 2023 meeting, the Advisory Committee on Immunization Practices* (ACIP) approved the Recommended Adult Immunization Schedule for Ages 19 Years or Older, United States, 2024. The adult immunization schedule, which can be found on the CDC immunization schedule website (https://www.cdc.gov/vaccines/schedules), is published annually to consolidate and summarize updates to ACIP recommendations on the vaccination of adults and to assist health care providers in implementing current ACIP recommendations. The 2024 immunization schedule includes several changes to the cover page, tables, notes, and appendix from the 2023 immunization schedule.† In addition, the 2024 adult immunization schedule includes a new addendum section that summarizes new or updated ACIP recommendations that will occur before the next annual update to the adult immunization schedule. Health care providers are advised to use the cover page, tables, notes, appendix, and addendum together to determine recommended vaccinations for patient populations.


Assuntos
Comitês Consultivos , Imunização , Adulto , Humanos , Centers for Disease Control and Prevention, U.S. , Esquemas de Imunização , Estados Unidos , Vacinação
5.
MMWR Morb Mortal Wkly Rep ; 72(6): 141-144, 2023 Feb 10.
Artigo em Inglês | MEDLINE | ID: mdl-36757861

RESUMO

At its October 2022 meeting, the Advisory Committee on Immunization Practices* (ACIP) approved the Recommended Adult Immunization Schedule for Ages 19 Years or Older, United States, 2023. The 2023 adult immunization schedule summarizes ACIP recommendations, including several changes to the cover page, tables, notes, and appendix from the 2022 immunization schedule.† This schedule can be found on the CDC immunization schedule website (https://www.cdc.gov/vaccines/schedules). Health care providers are advised to use the cover page, tables, notes, and appendix together to determine recommended vaccinations for patient populations. This adult immunization schedule is recommended by ACIP (https://www.cdc.gov/vaccines/acip) and approved by CDC (https://www.cdc.gov), the American College of Physicians (https://www.acponline.org), the American Academy of Family Physicians (https://www.aafp.org), the American College of Obstetricians and Gynecologists (https://www.acog.org), the American College of Nurse-Midwives (https://www.midwife.org), the American Academy of Physician Associates (https://www.aapa.org), the American Pharmacists Association (https://www.pharmacist.com), and the Society for Healthcare Epidemiology of America (https://shea-online.org).


Assuntos
Comitês Consultivos , Imunização , Adulto , Humanos , Centers for Disease Control and Prevention, U.S. , Esquemas de Imunização , Estados Unidos , Vacinação
6.
MMWR Morb Mortal Wkly Rep ; 72(6): 137-140, 2023 Feb 10.
Artigo em Inglês | MEDLINE | ID: mdl-36757872

RESUMO

At its October 2022 meeting, the Advisory Committee on Immunization Practices* (ACIP) approved the Recommended Child and Adolescent Immunization Schedule for Ages 18 Years or Younger, United States, 2023. The 2023 child and adolescent immunization schedule, available on the CDC immunization schedule website (https://www.cdc.gov/vaccines/schedules), summarizes ACIP recommendations, including several changes from the 2022 immunization schedule† on the cover page, tables, notes, and appendix. Health care providers are advised to use the tables, notes, and appendix together to determine recommended vaccinations for patient populations. This immunization schedule is recommended by ACIP (https://www.cdc.gov/vaccines/acip) and approved by CDC (https://www.cdc.gov), the American Academy of Pediatrics (https://www.aap.org), the American Academy of Family Physicians (https://www.aafp.org), the American College of Obstetricians and Gynecologists (http://www.acog.org), the American College of Nurse-Midwives (https://www.midwife.org), the American Academy of Physician Associates (https://www.aapa.org), and the National Association of Pediatric Nurse Practitioners (https://www.napnap.org).


Assuntos
Comitês Consultivos , Imunização , Adolescente , Criança , Humanos , Centers for Disease Control and Prevention, U.S. , Esquemas de Imunização , Estados Unidos , Vacinação
7.
MMWR recomm. rep ; 71(3): 90-95, March 18, 2022. tab
Artigo em Inglês | BIGG - guias GRADE | ID: biblio-1397086

RESUMO

On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the adenovirus-vectored COVID-19 vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson), and on February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for its use as a single-dose primary vaccination in persons aged ≥18 years (1,2). On April 13, 2021, CDC and FDA recommended a pause in the use of Janssen COVID-19 vaccine after reports of thrombosis with thrombocytopenia syndrome (TTS), a rare condition characterized by low platelets and thrombosis, including at unusual sites such as the cerebral venous sinus (cerebral venous sinus thrombosis [CVST]), after receipt of the vaccine.* ACIP rapidly convened two emergency meetings to review reported cases of TTS, and 10 days after the pause commenced, ACIP reaffirmed its interim recommendation for use of the Janssen COVID-19 vaccine in persons aged ≥18 years, but included a warning regarding rare clotting events after vaccination, primarily among women aged 18­49 years (3). In July, after review of an updated benefit-risk assessment accounting for risks of Guillain-Barré syndrome (GBS) and TTS, ACIP concluded that benefits of vaccination with Janssen COVID-19 vaccine outweighed risks. Through ongoing safety surveillance and review of reports from the Vaccine Adverse Event Reporting System (VAERS), additional cases of TTS after receipt of Janssen COVID-19 vaccine, including deaths, were identified. On December 16, 2021, ACIP held an emergency meeting to review updated data on TTS and an updated benefit-risk assessment. At that meeting, ACIP made a recommendation for preferential use of mRNA COVID-19 vaccines over the Janssen COVID-19 vaccine, including both primary and booster doses administered to prevent COVID-19, for all persons aged ≥18 years. The Janssen COVID-19 vaccine may be considered in some situations, including for persons with a contraindication to receipt of mRNA COVID-19 vaccines. Since June 2020, ACIP has convened 23 public meetings to review data on the epidemiology of COVID-19 and the use of COVID-19 vaccines, including nine during which Janssen COVID-19 vaccine-related data were reviewed. The ACIP COVID-19 Vaccines Work Group, comprising experts in infectious diseases, vaccinology, vaccine safety, public health, and ethics, has held weekly meetings to review COVID-19 surveillance data, evidence for vaccine efficacy and safety, and implementation considerations for COVID-19 vaccines. In addition, the COVID-19 Vaccines Safety Technical Work Group (VaST), consisting of independent vaccine safety experts and established to provide expert consultation on COVID-19 vaccine safety issues, has reviewed safety data from the COVID-19 vaccination program during weekly meetings. After TTS was first identified in the United States in April 2021, a benefit-risk assessment for the use of the Janssen COVID-19 vaccine was presented to ACIP using an adapted Evidence to Recommendations (EtR) framework.† In the setting of limited COVID-19 vaccine supply in the United States at that time, ACIP reaffirmed its interim recommendations for the use of the Janssen COVID-19 vaccine in persons aged ≥18 years under FDA's EUA, which was updated to include a warning that rare clotting events might occur after vaccination, primarily among women aged 18­49 years (3). Updates to the benefit-risk assessment were also reviewed by ACIP in June 2021, after an increased risk for myocarditis, particularly in males aged 12­29 years, was observed after receipt of mRNA COVID-19 vaccines; and again, in July 2021, after an increased number of cases of GBS were identified following administration of Janssen COVID-19 vaccine (4,5). After each review, ACIP determined that the benefits of COVID-19 vaccination in preventing COVID-19 morbidity and associated mortality outweighed the risks for these rare, but serious adverse events; however, the balance of benefits and risks varied by age and sex. Ongoing postauthorization safety surveillance identified additional TTS cases and associated deaths after Janssen COVID-19 vaccination, and updated safety data were reviewed by VaST in December 2021. The COVID-19 Vaccines Work Group also reviewed an updated benefit-risk assessment of COVID-19 vaccines in the setting of new safety findings and sufficient COVID-19 vaccine supply in the United States. In addition, FDA updated the EUA fact sheets with additional TTS data in December 2021.§ A summary of the data reviewed and discussions from both VaST and the ACIP COVID-19 Vaccines Work Group were presented to ACIP during their emergency meeting on December 16, 2021.


Assuntos
Humanos , Masculino , Feminino , Adolescente , Adulto , Pessoa de Meia-Idade , Idoso , Trombose/complicações , Programas de Imunização/normas , Síndrome de Guillain-Barré/complicações , COVID-19/prevenção & controle , Ad26COVS1/efeitos adversos
8.
MMWR Morb Mortal Wkly Rep ; 71(7): 234-237, 2022 Feb 18.
Artigo em Inglês | MEDLINE | ID: mdl-35176011

RESUMO

At its November 2021 meeting, the Advisory Committee on Immunization Practices* (ACIP) approved the Recommended Child and Adolescent Immunization Schedule for Ages 18 Years or Younger-United States, 2022. The 2022 child and adolescent immunization schedule, found on the CDC immunization schedule website (https://www.cdc.gov/vaccines/schedules), summarizes ACIP recommendations, including several changes from the 2021 immunization schedule† on the cover page, tables, and notes. The 2022 child and adolescent schedule also includes a newly created appendix that lists the contraindications and precautions for all vaccine types in the schedule. Health care providers are advised to use the tables, notes, and appendix together. This immunization schedule is recommended by ACIP (https://www.cdc.gov/vaccines/acip) and approved by CDC (https://www.cdc.gov), the American Academy of Pediatrics (https://www.aap.org), the American Academy of Family Physicians (https://www.aafp.org), the American College of Obstetricians and Gynecologists (http://www.acog.org), the American College of Nurse-Midwives (https://www.midwife.org), the American Academy of Physician Associates (https://www.aapa.org), and the National Association of Pediatric Nurse Practitioners (https://www.napnap.org).


Assuntos
Comitês Consultivos , Diretrizes para o Planejamento em Saúde , Esquemas de Imunização , Adolescente , Centers for Disease Control and Prevention, U.S. , Criança , Pré-Escolar , Humanos , Lactente , Estados Unidos
9.
MMWR Morb Mortal Wkly Rep ; 71(7): 229-233, 2022 Feb 18.
Artigo em Inglês | MEDLINE | ID: mdl-35176010

RESUMO

At its November 2021 meeting, the Advisory Committee on Immunization Practices* (ACIP) approved the Recommended Adult Immunization Schedule for Ages 19 Years or Older, United States, 2022. The 2022 adult immunization schedule summarizes ACIP recommendations, including several changes to the cover page, tables, and notes from the 2021 immunization schedule.† In addition, the 2022 adult immunization schedule provides an appendix that lists the contraindications to and precautions for all routinely recommended vaccines in the schedule. This schedule can be found on the CDC immunization schedule website (https://www.cdc.gov/vaccines/schedules). Health care providers are advised to use the cover page, tables, notes, and appendix together. This adult immunization schedule is recommended by ACIP (https://www.cdc.gov/vaccines/acip) and approved by CDC (https://www.cdc.gov), the American College of Physicians (https://www.acponline.org), the American Academy of Family Physicians (https://www.aafp.org), the American College of Obstetricians and Gynecologists (https://www.acog.org), the American College of Nurse-Midwives (https://www.midwife.org), the American Academy of Physician Associates (https://www.aapa.org), and the Society for Healthcare Epidemiology of America (https://www.shea-online.org).


Assuntos
Comitês Consultivos , Diretrizes para o Planejamento em Saúde , Esquemas de Imunização , Adulto , Idoso , Centers for Disease Control and Prevention, U.S. , Humanos , Pessoa de Meia-Idade , Estados Unidos
10.
MMWR Morb Mortal Wkly Rep ; 71(3): 90-95, 2022 Jan 21.
Artigo em Inglês | MEDLINE | ID: mdl-35051137

RESUMO

On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the adenovirus-vectored COVID-19 vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson), and on February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for its use as a single-dose primary vaccination in persons aged ≥18 years (1,2). On April 13, 2021, CDC and FDA recommended a pause in the use of Janssen COVID-19 vaccine after reports of thrombosis with thrombocytopenia syndrome (TTS), a rare condition characterized by low platelets and thrombosis, including at unusual sites such as the cerebral venous sinus (cerebral venous sinus thrombosis [CVST]), after receipt of the vaccine.* ACIP rapidly convened two emergency meetings to review reported cases of TTS, and 10 days after the pause commenced, ACIP reaffirmed its interim recommendation for use of the Janssen COVID-19 vaccine in persons aged ≥18 years, but included a warning regarding rare clotting events after vaccination, primarily among women aged 18-49 years (3). In July, after review of an updated benefit-risk assessment accounting for risks of Guillain-Barré syndrome (GBS) and TTS, ACIP concluded that benefits of vaccination with Janssen COVID-19 vaccine outweighed risks. Through ongoing safety surveillance and review of reports from the Vaccine Adverse Event Reporting System (VAERS), additional cases of TTS after receipt of Janssen COVID-19 vaccine, including deaths, were identified. On December 16, 2021, ACIP held an emergency meeting to review updated data on TTS and an updated benefit-risk assessment. At that meeting, ACIP made a recommendation for preferential use of mRNA COVID-19 vaccines over the Janssen COVID-19 vaccine, including both primary and booster doses administered to prevent COVID-19, for all persons aged ≥18 years. The Janssen COVID-19 vaccine may be considered in some situations, including for persons with a contraindication to receipt of mRNA COVID-19 vaccines.


Assuntos
Ad26COVS1/efeitos adversos , Comitês Consultivos , Vacinas contra COVID-19/uso terapêutico , Trombocitopenia/induzido quimicamente , Vacinação/normas , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Idoso , COVID-19/prevenção & controle , Centers for Disease Control and Prevention, U.S. , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição de Risco , SARS-CoV-2/imunologia , Estados Unidos/epidemiologia
13.
MMWR Morb Mortal Wkly Rep ; 70(32): 1094-1099, 2021 Aug 13.
Artigo em Inglês | MEDLINE | ID: mdl-34383735

RESUMO

In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for Pfizer-BioNTech and Moderna COVID-19 vaccines, and in February 2021, FDA issued an EUA for the Janssen (Johnson & Johnson) COVID-19 vaccine. After each EUA, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for vaccine use; currently Pfizer-BioNTech is authorized and recommended for persons aged ≥12 years and Moderna and Janssen for persons aged ≥18 years (1-3). Both Pfizer-BioNTech and Moderna vaccines, administered as 2-dose series, are mRNA-based COVID-19 vaccines, whereas the Janssen COVID-19 vaccine, administered as a single dose, is a recombinant replication-incompetent adenovirus-vector vaccine. As of July 22, 2021, 187 million persons in the United States had received at least 1 dose of COVID-19 vaccine (4); close monitoring of safety surveillance has demonstrated that serious adverse events after COVID-19 vaccination are rare (5,6). Three medical conditions have been reported in temporal association with receipt of COVID-19 vaccines. Two of these (thrombosis with thrombocytopenia syndrome [TTS], a rare syndrome characterized by venous or arterial thrombosis and thrombocytopenia, and Guillain-Barré syndrome [GBS], a rare autoimmune neurologic disorder characterized by ascending weakness and paralysis) have been reported after Janssen COVID-19 vaccination. One (myocarditis, cardiac inflammation) has been reported after Pfizer-BioNTech COVID-19 vaccination or Moderna COVID-19 vaccination, particularly after the second dose; these were reviewed together and will hereafter be referred to as mRNA COVID-19 vaccination. ACIP has met three times to review the data associated with these reports of serious adverse events and has comprehensively assessed the benefits and risks associated with receipt of these vaccines. During the most recent meeting in July 2021, ACIP determined that, overall, the benefits of COVID-19 vaccination in preventing COVID-19 morbidity and mortality outweigh the risks for these rare serious adverse events in adults aged ≥18 years; this balance of benefits and risks varied by age and sex. ACIP continues to recommend COVID-19 vaccination in all persons aged ≥12 years. CDC and FDA continue to closely monitor reports of serious adverse events and will present any additional data to ACIP for consideration. Information regarding risks and how they vary by age and sex and type of vaccine should be disseminated to providers, vaccine recipients, and the public.


Assuntos
Vacinas contra COVID-19/administração & dosagem , Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle , Imunização/normas , Guias de Prática Clínica como Assunto , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Comitês Consultivos , COVID-19/epidemiologia , Aprovação de Drogas , Humanos , Estados Unidos/epidemiologia , Vacinas Sintéticas , Vacinas de mRNA
14.
MMWR Morb Mortal Wkly Rep ; 70(27): 977-982, 2021 Jul 09.
Artigo em Inglês | MEDLINE | ID: mdl-34237049

RESUMO

In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech COVID-19 (BNT162b2) vaccine and the Moderna COVID-19 (mRNA-1273) vaccine,† and the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for their use in persons aged ≥16 years and ≥18 years, respectively.§ In May 2021, FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include adolescents aged 12-15 years; ACIP recommends that all persons aged ≥12 years receive a COVID-19 vaccine. Both Pfizer-BioNTech and Moderna vaccines are mRNA vaccines encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both mRNA vaccines were authorized and recommended as a 2-dose schedule, with second doses administered 21 days (Pfizer-BioNTech) or 28 days (Moderna) after the first dose. After reports of myocarditis and pericarditis in mRNA vaccine recipients,¶ which predominantly occurred in young males after the second dose, an ACIP meeting was rapidly convened to review reported cases of myocarditis and pericarditis and discuss the benefits and risks of mRNA COVID-19 vaccination in the United States. Myocarditis is an inflammation of the heart muscle; if it is accompanied by pericarditis, an inflammation of the thin tissue surrounding the heart (the pericardium), it is referred to as myopericarditis. Hereafter, myocarditis is used to refer to myocarditis, pericarditis, or myopericarditis. On June 23, 2021, after reviewing available evidence including that for risks of myocarditis, ACIP determined that the benefits of using mRNA COVID-19 vaccines under the FDA's EUA clearly outweigh the risks in all populations, including adolescents and young adults. The EUA has been modified to include information on myocarditis after receipt of mRNA COVID-19 vaccines. The EUA fact sheets should be provided before vaccination; in addition, CDC has developed patient and provider education materials about the possibility of myocarditis and symptoms of concern, to ensure prompt recognition and management of myocarditis.


Assuntos
Vacinas contra COVID-19/administração & dosagem , Vacinas contra COVID-19/efeitos adversos , Imunização/normas , Miocardite/epidemiologia , Guias de Prática Clínica como Assunto , Vacinas Sintéticas/administração & dosagem , Vacinas Sintéticas/efeitos adversos , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Comitês Consultivos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Centers for Disease Control and Prevention, U.S. , Criança , Feminino , Humanos , Masculino , Estados Unidos/epidemiologia , Adulto Jovem , Vacinas de mRNA
16.
MMWR Morb Mortal Wkly Rep ; 70(17): 651-656, 2021 Apr 30.
Artigo em Inglês | MEDLINE | ID: mdl-33914723

RESUMO

On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Janssen COVID-19 (Ad.26.COV2.S) vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson; New Brunswick, New Jersey), and on February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for its use in persons aged ≥18 years (1,2). On April 13, 2021, CDC and FDA recommended a pause in the use of the Janssen COVID-19 vaccine after reports of six U.S. cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia, a rare thromboembolic syndrome, among Janssen COVID-19 vaccine recipients (3). Two emergency ACIP meetings were rapidly convened to review reported cases of thrombosis with thrombocytopenia syndrome (TTS) and to consider updated recommendations for use of the Janssen COVID-19 vaccine in the United States. On April 23, 2021, after a discussion of the benefits and risks of resuming vaccination, ACIP reaffirmed its interim recommendation for use of the Janssen COVID-19 vaccine in all persons aged ≥18 years under the FDA's EUA, which now includes a warning that rare clotting events might occur after vaccination, primarily among women aged 18-49 years. Patient and provider education about the risk for TTS with the Janssen COVID-19 vaccine, especially among women aged <50 years, as well as the availability of alternative COVID-19 vaccines, is required to guide vaccine decision-making and ensure early recognition and clinical management of TTS.


Assuntos
Vacinas contra COVID-19/administração & dosagem , Vacinas contra COVID-19/efeitos adversos , Aprovação de Drogas , Guias de Prática Clínica como Assunto , Trombocitopenia/epidemiologia , Trombose/epidemiologia , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Comitês Consultivos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Centers for Disease Control and Prevention, U.S. , Rotulagem de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição de Risco , Retirada de Medicamento Baseada em Segurança , Estados Unidos/epidemiologia , United States Food and Drug Administration , Adulto Jovem
17.
MMWR Morb Mortal Wkly Rep ; 70(6): 189-192, 2021 Feb 12.
Artigo em Inglês | MEDLINE | ID: mdl-33571172

RESUMO

At its October 2020 meeting, the Advisory Committee on Immunization Practices* (ACIP) approved the 2021 Recommended Child and Adolescent Immunization Schedule for Ages 18 Years or Younger. After Emergency Use Authorization of Pfizer-BioNTech COVID-19 vaccine by the Food and Drug Administration (FDA), ACIP issued an interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years at its December 12, 2020, meeting (1). In addition, ACIP approved an amendment to include COVID-19 vaccine recommendations in the child and adolescent immunization schedule. After Emergency Use Authorization of Moderna COVID-19 vaccine by FDA, ACIP issued an interim recommendation for use of Moderna COVID-19 vaccine in persons aged ≥18 years at its December 19, 2020, emergency meeting (2).


Assuntos
Imunização/normas , Guias de Prática Clínica como Assunto , Vacinas/administração & dosagem , Adolescente , Comitês Consultivos , Centers for Disease Control and Prevention, U.S. , Criança , Pré-Escolar , Humanos , Esquemas de Imunização , Lactente , Estados Unidos
18.
MMWR Recomm Rep ; 70(6): 1-16, 2021 12 17.
Artigo em Inglês | MEDLINE | ID: mdl-34978547

RESUMO

Dengue is a vectorborne infectious disease caused by dengue viruses (DENVs), which are predominantly transmitted by Aedes aegypti and Aedes albopictus mosquitos. Dengue is caused by four closely related viruses (DENV-1-4), and a person can be infected with each serotype for a total of four infections during their lifetime. Areas where dengue is endemic in the United States and its territories and freely associated states include Puerto Rico, American Samoa, the U.S. Virgin Islands, the Federated States of Micronesia, the Republic of Marshall Islands, and the Republic of Palau. This report summarizes the recommendations of the Advisory Committee on Immunization Practices (ACIP) for use of the Dengvaxia vaccine in the United States. The vaccine is a live-attenuated, chimeric tetravalent dengue vaccine built on a yellow fever 17D backbone. Dengvaxia is safe and effective in reducing dengue-related hospitalizations and severe dengue among persons who have had dengue infection in the past. Previous natural infection is important because Dengvaxia is associated with an increased risk for severe dengue in those who experience their first natural infection (i.e., primary infection) after vaccination. Dengvaxia was licensed by the Food and Drug Administration for use among children and adolescents aged 9-16 years (referred to in this report as children). ACIP recommends vaccination with Dengvaxia for children aged 9-16 having evidence of a previous dengue infection and living in areas where dengue is endemic. Evidence of previous dengue infection, such as detection of anti-DENV immunoglobulin G with a highly specific serodiagnostic test, will be required for eligible children before vaccination.


Assuntos
Vacinas contra Dengue , Febre Amarela , Adolescente , Comitês Consultivos , Animais , Criança , Vacinas contra Dengue/efeitos adversos , Humanos , Imunização , Estados Unidos/epidemiologia , Vacinação , Febre Amarela/induzido quimicamente
19.
Pediatr Ann ; 49(12): e516-e522, 2020 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-33290569

RESUMO

Primary care providers play key roles in ensuring that children and the community receive vaccines on time. Sometimes, this role includes the task of reassuring parents who are vaccine hesitant that vaccines are safe and effective. Now, because of coronavirus disease 2019 (COVID-19), providers are presented with the additional challenge of maintaining and strengthening routine vaccination during a pandemic. As COVID-19 cases increased and states implemented stay-at-home orders, outpatient visits declined significantly. As a result, childhood immunization rates also declined. Increasing communication efforts regarding the importance of vaccination will be worthwhile, as the effect of the COVID-19 pandemic has highlighted the threat of an infectious disease and has increased awareness of the vaccine development process. Prior to 2020, many parents had not seen the devastating consequences of an infectious disease. The pandemic may change a parent's perspective, particularly as it relates to the influenza vaccine. Providers should continue to promote the importance of well-child and vaccination visits. [Pediatr Ann. 2020;49(12):e516-e522.].


Assuntos
COVID-19/epidemiologia , Serviços de Saúde da Criança , Esquemas de Imunização , Pandemias , Atenção Primária à Saúde , COVID-19/diagnóstico , Cuidadores/educação , Criança , Humanos , Pais/educação , Estados Unidos/epidemiologia , Vacinação , Recusa de Vacinação
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