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1.
Atlanta; Centers for Disease Control and Prevention; rev; Aug. 31, 2022. 8 p. tab.
Não convencional em Inglês | BIGG - guias GRADE | ID: biblio-1396388

RESUMO

Local reactions were reported by the majority of vaccine recipients and at higher rates than placebo recipients (75.3% vs 20.6% after dose 2). Pain/tenderness at the injection site was the most common and most severe local reaction among vaccine recipients and reported more frequently after dose 2 than after dose 1. Injection site redness and swelling following either dose were reported less frequently but were more common after dose 2 than dose 1. There were no grade 4 local reactions reported. Overall the median time to onset for local reactions was 1-3 days. The median duration of local reactions was 1-3 days in the vaccine group.


Assuntos
Humanos , Criança , Adolescente , Adulto , Pessoa de Meia-Idade , Programas de Imunização/normas , Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle
2.
Atlanta; Centers for Disease Control and Prevention; rev; July 28, 2022. 3 p.
Não convencional em Inglês | BIGG - guias GRADE | ID: biblio-1396382

RESUMO

The Advisory Committee on Immunization Practices (ACIP) provides advice and guidance to the Director of the CDC regarding use of vaccines and related agents for control of vaccine-preventable diseases in the civilian population of the United States. Recommendations made by the ACIP are reviewed by the CDC Director and, if adopted, are published as official CDC/HHS recommendations in the Morbidity and Mortality Weekly Report (MMWR).


Assuntos
Programas de Imunização/normas , Centers for Disease Control and Prevention, U.S. , Vacinas contra COVID-19/provisão & distribuição , COVID-19/prevenção & controle
3.
Atlanta; Centers for Disease Control and Prevention; rev; July 27, 2022. 8 p. tab.
Não convencional em Inglês | BIGG - guias GRADE | ID: biblio-1396384

RESUMO

A Grading of Recommendations, Assessment, Development and Evaluation (GRADE) review of the evidence for benefits and harms for Novavax coronavirus disease 2019 (COVID-19) vaccine was presented to the Advisory Committee on Immunization Practices (ACIP) on July 19, 2022. GRADE evidence type indicates the certainty in estimates from the available body of evidence. Evidence certainty ranges from type 1 (high certainty) to type 4 (very low certainty) [1]. The policy question was, "Should vaccination with Novavax COVID-19 vaccine be recommended for persons 18 years of age and older during an Emergency Use Authorization?" The potential benefits pre-specified by the ACIP COVID-19 Vaccines Work Group were prevention of symptomatic laboratory-confirmed COVID-19 (critical), hospitalization due to COVID-19 (critical), death due to COVID-19 (important), and asymptomatic SARS-CoV-2 infection (important). The two pre-specified harms were serious adverse events (critical) and reactogenicity grade ≥3 (important). A systematic review of evidence on the efficacy and safety of a two-dose regimen of Novavax COVID-19 vaccine among persons aged 18 years and older was conducted. The quality of evidence from one Phase III randomized controlled trial was assessed using a modified GRADE approach [2-3]. A lower risk of symptomatic COVID-19 was observed with vaccination compared to placebo (relative risk [RR] 0.10, 95% confidence interval [CI]: 0.06, 0.18, evidence type 1), corresponding to a vaccine efficacy of 89.6% (95% CI: 82.4%, 93.8%). This was observed with a median follow-up of 2.5 months, during a period of Alpha variant predominance. The vaccine was also associated with a lower risk of severe illness due to COVID-19 (RR 0.00; 95% CI: 0.00, 1.00; evidence type 3), corresponding to a vaccine efficacy of 100% (95% CI: 0%, 100%). The measure of severe COVID-19 was used as surrogate for the GRADE outcome of hospitalization due to COVID-19. No hospitalizations or deaths due to COVID-19 were identified among vaccine recipients or placebo recipients in the per-protocol population.* In terms of harms, the available data indicated that serious adverse events were balanced between the vaccine and placebo arms (RR 0.92; 95% CI: 0.73, 1.16; evidence type 1). Reactogenicity grade ≥3 was associated with vaccination (RR 4.11; 95% CI: 3.70, 4.57; evidence type 1), 16.3% of vaccine recipients and 4% of placebo recipients reported any grade ≥3 local or systemic reactions following either dose 1 or dose 2.


Assuntos
Humanos , Programas de Imunização/normas , Vacinas contra COVID-19/uso terapêutico , COVID-19/prevenção & controle , Vacinas contra COVID-19/imunologia
4.
Atlanta; Centers for Disease Control and Prevention; rev; July 27, 2022. 8 p. tab.
Não convencional em Inglês | BIGG - guias GRADE | ID: biblio-1396385

RESUMO

A Grading of Recommendations, Assessment, Development and Evaluation (GRADE) review of the evidence for benefits and harms for Novavax coronavirus disease 2019 (COVID-19) vaccine was presented to the Advisory Committee on Immunization Practices (ACIP) on July 19, 2022. GRADE evidence type indicates the certainty in estimates from the available body of evidence. Evidence certainty ranges from type 1 (high certainty) to type 4 (very low certainty) [1]. The policy question was, "Should vaccination with Novavax COVID-19 vaccine be recommended for persons 18 years of age and older during an Emergency Use Authorization?" The potential benefits pre-specified by the ACIP COVID-19 Vaccines Work Group were prevention of symptomatic laboratory-confirmed COVID-19 (critical), hospitalization due to COVID-19 (critical), death due to COVID-19 (important), and asymptomatic SARS-CoV-2 infection (important). The two pre-specified harms were serious adverse events (critical) and reactogenicity grade ≥3 (important). A systematic review of evidence on the efficacy and safety of a two-dose regimen of Novavax COVID-19 vaccine among persons aged 18 years and older was conducted. The quality of evidence from one Phase III randomized controlled trial was assessed using a modified GRADE approach [2-3]. A lower risk of symptomatic COVID-19 was observed with vaccination compared to placebo (relative risk [RR] 0.10, 95% confidence interval [CI]: 0.06, 0.18, evidence type 1), corresponding to a vaccine efficacy of 89.6% (95% CI: 82.4%, 93.8%). This was observed with a median follow-up of 2.5 months, during a period of Alpha variant predominance. The vaccine was also associated with a lower risk of severe illness due to COVID-19 (RR 0.00; 95% CI: 0.00, 1.00; evidence type 3), corresponding to a vaccine efficacy of 100% (95% CI: 0%, 100%). The measure of severe COVID-19 was used as surrogate for the GRADE outcome of hospitalization due to COVID-19. No hospitalizations or deaths due to COVID-19 were identified among vaccine recipients or placebo recipients in the per-protocol population.* In terms of harms, the available data indicated that serious adverse events were balanced between the vaccine and placebo arms (RR 0.92; 95% CI: 0.73, 1.16; evidence type 1). Reactogenicity grade ≥3 was associated with vaccination (RR 4.11; 95% CI: 3.70, 4.57; evidence type 1), 16.3% of vaccine recipients and 4% of placebo recipients reported any grade ≥3 local or systemic reactions following either dose 1 or dose 2.


Assuntos
Humanos , Programas de Imunização/normas , Vacinas contra COVID-19/uso terapêutico , COVID-19/prevenção & controle
5.
Atlanta; Centers for Disease Control and Prevention; rev; July 27, 2022. 11 p. tab.
Não convencional em Inglês | BIGG - guias GRADE | ID: biblio-1396386

RESUMO

The emergence of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), in late 2019 has led to a global pandemic with dramatic societal and economic impact on individual persons and communities. In the United States, more than 89 million cases and more than 1 million COVID-19-associated deaths have been reported as of July 14, 2022. Persons of all ages are at risk for infection and severe disease. However, the risk for severe illness from COVID-19 is higher in people aged ≥65 years, those living in long-term care facilities, and those with chronic medical conditions. Additionally, there is a disproportionate burden of COVID-19 infections and deaths among racial and ethnic minority communities. Non-Hispanic Black, Hispanic/Latino (Hispanic) and American Indian/Alaska Native persons have experienced higher rates of disease, hospitalization and death compared with non-Hispanic White persons. This is likely related to inequities in social determinants of health that put racial and ethnic minority groups at increased risk for COVID-19, including overrepresentation among essential workers who have higher risk of exposure to COVID-19, lower incomes, reduced access to healthcare, or higher rates of comorbid conditions. In the United States, the first vaccines to prevent COVID-19 received Food and Drug Administration (FDA) Emergency Use Authorizations (EUA): Pfizer-BioNTech on December 11, 2020, for persons aged 16 years and older, Moderna on December 18, 2020, for adults aged 18 years and older, and Janssen on February 27, 2021, for adults aged 18 years and older. On July 13, 2022, the FDA issued an EUA for the Novavax COVID-19 vaccine, Adjuvanted for the prevention of COVID-19 in persons ages 18 years and older. Additional background information supporting the interim ACIP recommendation on the use of Novavax COVID-19 vaccine can be found in the relevant publication of the recommendation referenced on the ACIP website.


Assuntos
Humanos , Adulto , Programas de Imunização/normas , Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle
6.
Atlanta; Centers for Disease Control and Prevention; rev; July 28, 2022. 8 p. tab.
Não convencional em Inglês | BIGG - guias GRADE | ID: biblio-1396389

RESUMO

A Grading of Recommendations, Assessment, Development and Evaluation (GRADE) review of the evidence for benefits and harms for Moderna coronavirus disease 2019 (COVID-19) vaccine for children aged 6­11 years was presented to the Advisory Committee for Immunization Practices (ACIP) on June 23, 2022. GRADE evidence type indicates the certainty in estimates from the available body of evidence. Evidence certainty ranges from type 1 (high certainty) to type 4 (very low certainty) [1]. The policy question was, "Should vaccination with Moderna COVID-19 vaccine (2 doses, 50 µg) be recommended for children 6­11 years of age during an Emergency Use Authorization?" The potential benefits pre-specified by the ACIP COVID-19 Vaccines Work Group included prevention of symptomatic laboratory-confirmed COVID-19 (critical), hospitalization due to COVID-19 (important), multisystem inflammatory syndrome in children (MIS-C) (important), and asymptomatic SARS-CoV-2 infection (important). The two pre-specified harms were serious adverse events (SAEs) (critical) and reactogenicity grade ≥3 (important). A systematic review of evidence on the efficacy and safety of a two-dose regimen of Moderna COVID-19 vaccine among children aged 6­11 years was conducted. The quality of evidence from one Phase II/III randomized controlled trial was assessed using a modified GRADE approach [2]. Symptomatic COVID-19 was less common among the vaccine group compared with the placebo group (RR: 0.19; 95% CI: 0.05, 0.81; evidence type 2). A non-inferior geometric mean ratio (GMR) for antibodies in the 6­11-year-olds was observed with vaccination compared to the 18­25-year-olds (GMR 1.2, 95% confidence interval [CI]: 1.1, 1.4; evidence type 2). A lower risk of asymptomatic SARS-CoV-2 infection also seen in the vaccine group compared with the placebo group (Relative Risk [RR]: 0.29; 95% CI: 0.12, 0.71; evidence type 3). The available data indicated that SAEs were balanced between the vaccine and placebo arms, but certainty in the estimate was very low (RR 0.99; 95% CI: 0.20, 4.91; evidence type 4); none of these SAEs were assessed by the Food and Drug Administration (FDA) as related to study intervention. Reactogenicity grade ≥3 was associated with vaccination (RR 5.2; 95% CI: 3.6, 7.3; evidence type 1). About 17% of vaccine recipients and 3% of placebo recipients reported any grade ≥3 local or systemic reactions following either dose 1 or dose 2.


Assuntos
Humanos , Pré-Escolar , Criança , Programas de Imunização/normas , COVID-19/prevenção & controle , Vacina de mRNA-1273 contra 2019-nCoV/uso terapêutico , Vacina de mRNA-1273 contra 2019-nCoV/imunologia
7.
Atlanta; Centers for Disease Control and Prevention; rev; July 28, 2022. 8 p. tab..
Não convencional em Inglês | BIGG - guias GRADE | ID: biblio-1396390

RESUMO

A Grading of Recommendations, Assessment, Development and Evaluation (GRADE) review of the evidence for benefits and harms for Moderna coronavirus disease 2019 (COVID-19) vaccine for persons aged 12-17 years was presented to the Advisory Committee for Immunization Practices (ACIP) on June 23, 2022. GRADE evidence type indicates the certainty in estimates from the available body of evidence. Evidence certainty ranges from type 1 (high certainty) to type 4 (very low certainty) [1]. The policy question was, "Should vaccination with Moderna COVID-19 vaccine (2 doses, 100 µg) be recommended for persons 12-17 years of age during an Emergency Use Authorization?" The potential benefits pre-specified by the ACIP COVID-19 Vaccines Work Group included prevention of symptomatic laboratory-confirmed COVID-19 (critical), hospitalization due to COVID-19 (important), multisystem inflammatory syndrome in children (MIS-C) (important), and asymptomatic SARS-CoV-2 infection (important). The two pre-specified harms were serious adverse events (SAEs) (critical) and reactogenicity grade ≥3 (important). A systematic review of evidence on the efficacy and safety of a two-dose regimen of Moderna COVID-19 vaccine among persons aged 12-17 years was conducted. The quality of evidence from one Phase II/III randomized controlled trial was assessed using a modified GRADE approach. A lower risk of symptomatic COVID-19 was observed among the vaccine group compared with the placebo group (Relative risk [RR]: 0.11; 95% Confidence Interval [CI]: 0.02, 0.50; evidence type 2). Immunobridging data were also assessed in support of efficacy. Among adolescents ages 12 ­ 17 years, the immune response to vaccine was non-inferior to that observed in adults ages 18-25 years ( GMR: 1.1; 95% CI: 0.9, 1.2; evidence type 2). Additionally, a lower risk of asymptomatic SARS-CoV-2 infection was observed among the vaccine group compared with the placebo group, though the confidence interval was wide and crossed the null (RR: 0.61 (0.24, 1.54); evidence type 3). The available data indicated that SAEs were more common in vaccine recipients, but certainty in the estimate was very low (RR 1.50; 95% CI: 0.30, 7.40; evidence type 4), and none of these SAEs were assessed by the Food and Drug Administration (FDA) as related to study intervention. Reactogenicity grade ≥3 was associated with vaccination (RR 5.23; 95% CI: 4.05, 6.76; evidence type 1). About 25% of vaccine recipients and 5% of placebo recipients reported any grade ≥3 local or systemic reactions following either dose 1 or dose 2.


Assuntos
Humanos , Criança , Adolescente , Programas de Imunização/normas , COVID-19/prevenção & controle , Vacina de mRNA-1273 contra 2019-nCoV/uso terapêutico
8.
Atlanta; Centers for Disease Control and Prevention; rev; June 27, 2022. 9 p. tab.
Não convencional em Inglês | BIGG - guias GRADE | ID: biblio-1396392

RESUMO

A Grading of Recommendations, Assessment, Development and Evaluation (GRADE) review of the evidence for benefits and harms for Moderna coronavirus disease 2019 (COVID-19) vaccine for children aged 6 months­-­­5 years was presented to the Advisory Committee for Immunization Practices (ACIP) on June 18, 2022. GRADE evidence type indicates the certainty in estimates from the available body of evidence. Evidence certainty ranges from type 1 (high certainty) to type 4 (very low certainty) [1]. The policy question was, "Should vaccination with Moderna COVID-19 vaccine (2 doses, 25 µg) be recommended for children 6 months-5 years of age during an Emergency Use Authorization?" The potential benefits pre-specified by the ACIP COVID-19 Vaccines Work Group included prevention of symptomatic laboratory-confirmed COVID-19 (critical), hospitalization due to COVID-19 (important), multisystem inflammatory syndrome in children (MIS-C) (important), and asymptomatic SARS-CoV-2 infection (important). The two pre-specified harms were serious adverse events (SAEs) (critical) and reactogenicity grade ≥3 (important). A systematic review of evidence on the efficacy and safety of a two-dose regimen of Moderna COVID-19 vaccine among children aged 6 months­5 years was conducted. The quality of evidence from one Phase II/III randomized controlled trial was assessed using a modified GRADE approach [2]. A lower risk of symptomatic COVID-19 was observed with vaccination compared with placebo (relative risk [RR]: 0.62; 95% confidence interval [CI]: 0.49, 0.79, evidence type 1). Immunobridging was also assessed. In both age groups, 6­23 months and 2­5 years, the immune response to vaccine was non-inferior to that observed in adults ages 18-25 years (6­23 months GMR: 1.28; 95% CI: 1.12, 1.47; 2­5 years GMR: 1.01; 95% CI: 0.88, 1.17; evidence type 2). There was also a lower risk of asymptomatic SARS-CoV-2 infection seen in the vaccine group compared with the placebo group, however the confidence interval crossed the line of no effect (RR: 0.84; 95% CI: 0.60,1.19; evidence type 3). The available data indicated that SAEs were more common in vaccine recipients, but certainty in the estimate was very low (RR 2.67; 95% CI: 0.80, 8.84; evidence type 4). Two serious adverse events in one participant were determined by the Food and Drug Administration (FDA) as potentially related to the vaccination. No specific safety concerns were identified among vaccine recipients aged 6 months­5 years. Reactogenicity grade ≥3 was associated with vaccination (RR 1.87; 95% CI: 1.44, 2.42); evidence type 1). About 7.7% of vaccine recipients and 4.4% of placebo recipients reported any grade ≥3 local or systemic reactions following either dose 1 or dose 2.


Assuntos
Humanos , Lactente , Pré-Escolar , Programas de Imunização/normas , COVID-19/prevenção & controle , Vacina de mRNA-1273 contra 2019-nCoV/uso terapêutico , Vacina de mRNA-1273 contra 2019-nCoV/imunologia
9.
Atlanta; Centers for Disease Control and Prevention; June, 27 2022. 8 p. tab.
Não convencional em Inglês | BIGG - guias GRADE | ID: biblio-1396393

RESUMO

Grading of Recommendations, Assessment, Development and Evaluation (GRADE) review of the evidence for benefits and harms for Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccine for children aged 6 months­­­­4 years was presented to the Advisory Committee for Immunization Practices (ACIP) on June 18, 2022. GRADE evidence type indicates the certainty in estimates from the available body of evidence. Evidence certainty ranges from type 1 (high certainty) to type 4 (very low certainty) [1]. The policy question was, "Should vaccination with Pfizer-BioNTech COVID-19 vaccine (3 doses, 3 µg) be recommended for children 6 months­4 years of age during an Emergency Use Authorization?" The potential benefits pre-specified by the ACIP COVID-19 Vaccines Work Group included prevention of symptomatic laboratory-confirmed COVID-19 (critical), hospitalization due to COVID-19 (important), multisystem inflammatory syndrome in children (MIS-C) (important), and asymptomatic SARS-CoV-2 infection (important). The two pre-specified harms were serious adverse events (SAEs) (critical) and reactogenicity grade ≥3 (important). A systematic review of evidence on the efficacy and safety of a three-dose regimen of Pfizer-BioNTech COVID-19 vaccine among children aged 6 months­4 years was conducted. The quality of evidence from one Phase II/III randomized controlled trial was assessed using a modified GRADE approach [2]. A lower risk of symptomatic COVID-19 was observed with vaccination compared with placebo, but certainty in the estimate was very low (relative risk [RR]: 0.20; 95% confidence interval [CI]: 0.05, 0.77, evidence type 4). Immunobridging was also assessed in support of efficacy. In both age groups, 6­23 months and 2­4 years, the immune response to vaccine was non-inferior to that observed in young adults ages 16-25 years (6­23 months: GMR: 1.19; 95% CI: 1.00, 1.43; 2­4 years: GMR: 1.30; 95% CI: 1.13, 1.50; evidence type 2). The available data indicated that SAEs were balanced comparing vaccine and placebo recipients, but certainty in the estimate was low (RR 0.66; 95% CI: 0.38, 1.15; evidence type 4). One vaccine recipient had two SAEs which were considered potentially related by the investigator and FDA. FDA noted that the events were also consistent with viral myositis. Reactogenicity grade ≥3 was slightly higher in the vaccine group, but the confidence interval crossed the null (RR 1.20; 95% CI: 0.88, 1.64); evidence type 2). About 4.3% of vaccine recipients and 3.6% of placebo recipients reported any grade ≥3 local or systemic reactions following dose 1, dose 2, or dose 3.


Assuntos
Humanos , Lactente , Pré-Escolar , Criança , Programas de Imunização/normas , COVID-19/prevenção & controle , Vacina BNT162/uso terapêutico , Vacinas contra COVID-19/imunologia
10.
Atlanta; Centers for Disease Control and Prevention; rev; June 21, 2022. 14 p. tab.
Não convencional em Inglês | BIGG - guias GRADE | ID: biblio-1396395

RESUMO

Local reactions were reported by the majority of vaccine recipients and at higher rates than placebo recipients. Vaccine recipients reported higher rates of local reactions after dose 2 than dose 1. The frequency of local reactions was higher in the older age group (ages 2 to 5 years) than the younger age group (ages 6-23 months) (73.4% vs 54.4% after dose 2). Pain at the injection site was the most frequent and severe reported solicited local reaction among vaccine recipients. After dose 1, the older age group reported pain more frequently than the younger age group (61.4% vs 37.4%); a similar pattern was observed after dose 2 (71.4% vs 46.2%). Axillary (or groin) swelling or tenderness was the second most frequently reported local reaction. Axillary (or groin) swelling or tenderness was reported slightly more frequently in the younger age group than the older age group (9.3% vs 9.1% after dose 2). Injection site redness and swelling following either dose were reported less frequently. Redness and swelling were more common after dose 2. No grade 4 local reactions were reported. Overall, the median onset of local reactions in the vaccine group was 1 day after either dose, with a median duration of 2 days.


Assuntos
Humanos , Criança , Adolescente , Adulto , Pessoa de Meia-Idade , Idoso , Programas de Imunização/normas , COVID-19/prevenção & controle , Vacina de mRNA-1273 contra 2019-nCoV/efeitos adversos
11.
Atlanta; Centers for Disease Control and Prevention; rev; May 31, 2022. 6 p. tab.
Não convencional em Inglês | BIGG - guias GRADE | ID: biblio-1396396

RESUMO

The emergence of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has led to a global pandemic with substantial societal and economic impacts on individual persons and communities. In the United States, more than 82 million cases and more than 998,000 COVID-19-associated deaths have been reported as of May 16, 2022. Persons of all ages are at risk for infection and severe disease. While children <18 years of age infected with SARS-CoV-2 are less likely to develop severe illness compared with adults, children are still at risk of developing severe illness and complications from COVID-19 and contribute to transmission in households and communities. A disproportionate burden of COVID-19 infections and deaths occur among racial and ethnic minority communities, including among children. Non-Hispanic Black, Hispanic/Latino and American Indian/American Native persons have experienced higher rates of disease, hospitalization and death compared with non-Hispanic Whites. This is likely related to inequities in social determinants of health that put racial and ethnic minority groups at increased risk for COVID-19, including income disparities, reduced access to healthcare, or higher rates of comorbid conditions. On October 29, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 vaccine in persons ages 5-11 years for prevention of COVID-19. The vaccine was safe and met non-inferiority criteria for immunobridging compared with young adults ages 16-25 years in a randomized controlled clinical trial that included 2,268 participants randomized 2:1 to receive either vaccine or placebo. On May 17, 2022, the FDA amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 vaccine. Following FDA's regulatory action, CDC expanded eligibility of COVID-19 vaccine booster doses to everyone 5 years of age and older on May 19, 2022. Additional background information supporting the ACIP recommendation on the use of additional or booster doses of COVID-19 vaccine can be found in the relevant publication of the recommendation referenced on the ACIP website.


Assuntos
Humanos , Pré-Escolar , Criança , Programas de Imunização/normas , COVID-19/prevenção & controle , Vacina BNT162/uso terapêutico , Vacina BNT162/imunologia
12.
Atlanta; Centers for Disease Control and Prevention; rev; May 23, 2022. 7 p. tab.
Não convencional em Inglês | BIGG - guias GRADE | ID: biblio-1396397

RESUMO

The emergence of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has led to a global pandemic with substantial societal and economic impacts on individual persons and communities. In the United States, more than 80 million cases and more than 986,000 COVID-19-associated deaths have been reported as of April 17, 2022. Persons of all ages are at risk for infection and severe disease. However, the risk for severe illness from COVID-19 is higher in people ages ≥50 years and those who are immunocompromised. Three COVID-19 vaccines are currently approved under a Biologics License Application or authorized under an Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) and recommended for primary vaccination by the Advisory Committee on Immunization Practices (ACIP): the two-dose mRNA-based Pfizer-BioNTech/Comirnaty and Moderna COVID-19 vaccines and the single-dose adenovirus vector-based Janssen (Johnson & Johnson) COVID-19 vaccine. On August 12, 2021, the FDA amended the EUAs for Pfizer-BioNTech (persons aged ≥12 years) and Moderna (persons aged ≥18 years) COVID-19 vaccines to authorize an additional dose for certain immunocompromised persons. Due to insufficient data, the EUA amendment for an additional dose did not apply to Janssen COVID-19 vaccine or to individuals who received Janssen COVID-19 vaccine as a primary series. Previous data on the use of additional doses of COVID-19 vaccine is linked here: EtR for Use of an Additional COVID-19 Vaccine Dose in Immunocompromised People | CDC. Additionally, during September-October, 2021, the FDA amended the COVID-19 vaccine EUAs to allow for booster doses of Pfizer-BioNTech, Moderna, or Janssen COVID-19 vaccines in persons who completed primary vaccination with these vaccines, as well as use of each of the available COVID-19 vaccines as a heterologous (or "mix and match") booster dose in eligible individuals following completion of primary vaccination with a different COVID-19 vaccine. Previous data on the use of booster doses of COVID-19 vaccine is linked here: EtR for Use of COVID-19 Vaccine Booster Doses | CDC. On March 29, 2022, the FDA amended the COVID-19 vaccine EUAs to authorize a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for individuals 50 years of age and older as well as certain immunocompromised individuals 12 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. Following FDA's regulatory action on March 29, 2022, CDC updated its COVID-19 vaccination guidance to allow certain immunocompromised individuals and people over the age of 50 who received an initial booster dose at least 4 months ago to be eligible for another mRNA booster to increase their protection against severe disease from COVID-19. Separately, and in addition, based on newly published data, adults who received a primary vaccine and booster dose of Johnson & Johnson's COVID-19 vaccine at least 4 months ago may now receive a second booster dose using an mRNA COVID-19 vaccine. Additional background information supporting the ACIP recommendation on the use of additional or booster doses of COVID-19 vaccine can be found in the relevant publication of the recommendation referenced on the ACIP website.


Assuntos
Humanos , Pessoa de Meia-Idade , COVID-19/prevenção & controle , Vacina de mRNA-1273 contra 2019-nCoV/imunologia , Tolerância Imunológica/efeitos dos fármacos , Vacina de mRNA-1273 contra 2019-nCoV/uso terapêutico
14.
Preprint em Inglês | medRxiv | ID: ppmedrxiv-20036368

RESUMO

We report the first 7,755 patients with confirmed COVID-19 in Korea as of March 13, 2020. A total of 66 deaths were identified, resulting case fatality proportion of 0.9%. Older people, and those with coexisting medical conditions were at risk for fatal outcomes. The highest number of cases were from Daegu, followed by Gyeongbuk, with elevated age-stratified case fatality. This summary may help to understand the disease dynamics in the early phase of COVID-19 outbreak, therefore, to guide future public health measures.

15.
Preprint em Inglês | medRxiv | ID: ppmedrxiv-20036350

RESUMO

Between January 24 and March 10, of a total of 2,370 individuals who had contacted the first 30 cases of COVID-19, 13 were found to have COVID-19, resulting secondary attack rate of 0.55% (95% CI 0.31 - 0.96). Of 119 household contacts, 9 had infections resulting secondary attack rate of 7.56 (95% CI 3.73 - 14.26).

16.
Recurso na Internet em Inglês | LIS - Localizador de Informação em Saúde | ID: lis-47025

RESUMO

Site institucional do Centro de Controle e Prevenção de Doenças dos Estados Unidos da América, Informações sobre o Coronavirus, atualização da situação.


Assuntos
Coronavirus , Identificação da Emergência
17.
Recurso na Internet em Inglês | LIS - Localizador de Informação em Saúde, LIS-ES-PROF, LIS-ES-CIUD | ID: lis-46970

RESUMO

Página de los CDC con información dirigida a: profesionales sanitarios (guías provisionales para evaluar a los pacientes, diagramas de flujo, recomendaciones para tratar a pacientes con la infección confirmada o con sospecha, listas de comprobación para pacientes potenciales o confirmados, artículos de revistas y publicaciones), profesionales de salud pública (nº de casos en EE.UU. y a nivel mundial, medidas de prevención en hogares y comunidades, preguntas más frecuentes, recursos clave en la preparación para el control de la infección), laboratorios (guías para muestras clínicas, guías para laboratorios de bioseguridad, protocolos de identificación), ciudadanos, pacientes y cuidadores (información sobre la transmisión, síntomas y complicaciones, prevención y tratamiento, preguntas más frecuentes), viajeros (viajes a China, procedentes de China, tripulación), etc.


Assuntos
Betacoronavirus , Infecções por Coronavirus , Pneumonia Viral
20.
Morb. mort. wkly. rep. (Print) ; 68(4): 1-14, Dec. 13, 2019. tab
Artigo em Inglês | AIM (África), BIGG - guias GRADE | ID: biblio-1397576

RESUMO

This report updates the 2009 recommendations from the CDC Advisory Committee on Immunization Practices (ACIP) regarding use of anthrax vaccine in the United States (Wright JG, Quinn CP, Shadomy S, Messonnier N. Use of anthrax vaccine in the United States: recommendations of the Advisory Committee on Immunization Practices [ACIP)], 2009. MMWR Recomm Rep 2010;59[No. RR-6]). The report 1) summarizes data on estimated efficacy in humans using a correlates of protection model and safety data published since the last ACIP review, 2) provides updated guidance for use of anthrax vaccine adsorbed (AVA) for preexposure prophylaxis (PrEP) and in conjunction with antimicrobials for postexposure prophylaxis (PEP), 3) provides updated guidance regarding PrEP vaccination of emergency and other responders, 4) summarizes the available data on an investigational anthrax vaccine (AV7909), and 5) discusses the use of anthrax antitoxins for PEP. Changes from previous guidance in this report include the following: 1) a booster dose of AVA for PrEP can be given every 3 years instead of annually to persons not at high risk for exposure to Bacillus anthracis who have previously received the initial AVA 3-dose priming and 2-dose booster series and want to maintain protection; 2) during a large-scale emergency response, AVA for PEP can be administered using an intramuscular route if the subcutaneous route of administration poses significant materiel, personnel, or clinical challenges that might delay or preclude vaccination; 3) recommendations on dose-sparing AVA PEP regimens if the anthrax vaccine supply is insufficient to vaccinate all potentially exposed persons; and 4) clarification on the duration of antimicrobial therapy when used in conjunction with vaccine for PEP. These updated recommendations can be used by health care providers and guide emergency preparedness officials and planners who are developing plans to provide anthrax vaccine, including preparations for a wide-area aerosol release of B. anthracis spores. The recommendations also provide guidance on dose-sparing options, if needed, to extend the supply of vaccine to increase the number of persons receiving PEP in a mass casualty event.


Assuntos
Humanos , Adolescente , Adulto , Pessoa de Meia-Idade , Idoso , Centers for Disease Control and Prevention, U.S. , Vacinas contra Antraz/uso terapêutico , Comitês Consultivos , Antraz/imunologia , Antitoxinas/uso terapêutico , Vacinas contra Antraz/administração & dosagem
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