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Current status of monkeypox vaccines

npj vaccines, 2022-08, Vol.7 (1), p.94-94, Article 94

Gruber, Marion F.

2022

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Considerations in boosting COVID-19 vaccine immune responses

The Lancet (British edition), 2021-10, Vol.398 (10308), p.1377-1380

2021

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An overview of the regulation of influenza vaccines in the United States

Influenza and other respiratory viruses, 2016-09, Vol.10 (5), p.354-360

2016

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Approaches to demonstrating the effectiveness of filovirus vaccines: Lessons from Ebola and COVID-19

Frontiers in immunology, 2023-02, Vol.14, p.1109486-1109486

2023

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Report of the second international conference on next generation sequencing for adventitious virus detection in biologics for humans and animals

Biologicals, 2020-09, Vol.67, p.94-111

2020

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Emergency Use Authorization of Covid Vaccines — Safety and Efficacy Follow-up Considerations

The New England journal of medicine, 2020-11, Vol.383 (19), p.e107

2020

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Regulating vaccines at the FDA: development and licensure of Zika vaccines

Expert review of vaccines, 2017-06, Vol.16 (6), p.525-527

2017

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The US FDA pregnancy lactation and labeling rule – Implications for maternal immunization

Vaccine, 2015-11, Vol.33 (47), p.6499-6500

Gruber, Marion F

2015

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Realising the potential of correlates of protection for vaccine development, licensure and use: short summary

npj vaccines, 2024-04, Vol.9 (1), p.82-82, Article 82

2024

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Regulatory considerations in the clinical development of vaccines indicated for use during pregnancy

Vaccine, 2015-02, Vol.33 (8), p.966-972

2015

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Global and National Initiatives to Facilitate Studies of Vaccines in Pregnant Women

Clinical infectious diseases, 2014-12, Vol.59 (suppl_7), p.S395-S399

Gruber, Marion F.

2014

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Evaluating human trials: FDA's role

Science (American Association for the Advancement of Science), 2018-06, Vol.360 (6395), p.1308-1308

2018

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Making more COVID-19 vaccines available to address global needs: Considerations and a framework for their evaluation

Vaccine, 2022-09, Vol.40 (40), p.5749-5751

2022

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Approaches to demonstration of Ebola virus vaccine efficacy

The Lancet infectious diseases, 2015-06, Vol.15 (6), p.627-629

2015

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Enabling the evaluation of COVID-19 vaccines with correlates of protection

Biologicals, 2024-02, Vol.85, p.101723-101723, Article 101723

2024

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Clinical Development Strategies and Considerations for Zika Vaccine Licensure

The Journal of infectious diseases, 2017-12, Vol.216 (suppl_10), p.S964-S970

2017

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Immunology of protection from Ebola virus infection

Science translational medicine, 2015-05, Vol.7 (286), p.286ps11

2015

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US FDA review and regulation of preventive vaccines for infectious disease indications: impact of the FDA Amendments Act 2007

Expert review of vaccines, 2011-07, Vol.10 (7), p.1011-1019

Gruber, Marion F

2011

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Clinical Evaluation of Pertussis Vaccines: US Food and Drug Administration Regulatory Considerations

The Journal of infectious diseases, 2014-04, Vol.209 (suppl 1), p.S28-S31

2014

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Maternal immunization: US FDA regulatory considerations

Vaccine, 2003-07, Vol.21 (24), p.3487-3491

Gruber, Marion F.

2003

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Global and National Initiatives to Facilitate Studies of Vaccines in Pregnant Women: Including Pregnant Women in Clinical Trials of Antimicrobials and Vaccines

Clinical infectious diseases, 2014, Vol.59

GRUBER, Marion F

2014

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Clinical Evaluation of Pertussis Vaccines: US Food and Drug Administration Regulatory Considerations: Prevention and Control of Pertussis

The Journal of infectious diseases, 2014, Vol.209

2014

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Regulation and Testing of Vaccines

Plotkin's Vaccines, 2018, p.1547-1565.e2

Seventh Edition, 2018

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Chapter 80 - Regulation and Testing of Vaccines in the US

Plotkin's Vaccines, 2023, p.1640-1659.e2

Eighth Edition, 2023

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Prevention of Pertussis, Tetanus, and Diphtheria Among Pregnant and Postpartum Women and Their Infants: Recommendations of the Advisory Committee on Immunization Practices (ACIP)

MMWR. Recommendations and reports, 2008-05, Vol.57 (RR-4), p.1-50

2008

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Current status of monkeypox vaccines

Considerations in boosting COVID-19 vaccine immune responses

An overview of the regulation of influenza vaccines in the United States

Approaches to demonstrating the effectiveness of filovirus vaccines: Lessons from Ebola and COVID-19

Report of the second international conference on next generation sequencing for adventitious virus detection in biologics for humans and animals

Emergency Use Authorization of Covid Vaccines — Safety and Efficacy Follow-up Considerations

Regulating vaccines at the FDA: development and licensure of Zika vaccines

The US FDA pregnancy lactation and labeling rule – Implications for maternal immunization

Realising the potential of correlates of protection for vaccine development, licensure and use: short summary

Regulatory considerations in the clinical development of vaccines indicated for use during pregnancy

Global and National Initiatives to Facilitate Studies of Vaccines in Pregnant Women

Evaluating human trials: FDA's role

Making more COVID-19 vaccines available to address global needs: Considerations and a framework for their evaluation

Approaches to demonstration of Ebola virus vaccine efficacy

Enabling the evaluation of COVID-19 vaccines with correlates of protection

Clinical Development Strategies and Considerations for Zika Vaccine Licensure

Immunology of protection from Ebola virus infection

US FDA review and regulation of preventive vaccines for infectious disease indications: impact of the FDA Amendments Act 2007

Clinical Evaluation of Pertussis Vaccines: US Food and Drug Administration Regulatory Considerations

Maternal immunization: US FDA regulatory considerations

Global and National Initiatives to Facilitate Studies of Vaccines in Pregnant Women: Including Pregnant Women in Clinical Trials of Antimicrobials and Vaccines

Clinical Evaluation of Pertussis Vaccines: US Food and Drug Administration Regulatory Considerations: Prevention and Control of Pertussis

Regulation and Testing of Vaccines

Chapter 80 - Regulation and Testing of Vaccines in the US

Prevention of Pertussis, Tetanus, and Diphtheria Among Pregnant and Postpartum Women and Their Infants: Recommendations of the Advisory Committee on Immunization Practices (ACIP)

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