Literature DB >> 21502242

Food and Drug Administration regulation and evaluation of vaccines.

Valerie Marshall1, Norman W Baylor.   

Abstract

The vaccine-approval process in the United States is regulated by the Center for Biologics Evaluation and Research of the US Food and Drug Administration. Throughout the life cycle of development, from preclinical studies to after licensure, vaccines are subject to rigorous testing and oversight. Manufacturers must adhere to good manufacturing practices and control procedures to ensure the quality of vaccines. As mandated by Title 21 of the Code of Regulations, licensed vaccines must meet stringent criteria for safety, efficacy, and potency.

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Year:  2011        PMID： 21502242     DOI： 10.1542/peds.2010-1722E

Source DB:  PubMed          Journal:  Pediatrics        ISSN： 0031-4005            Impact factor:   7.124


  10 in total

Review 1.  Deaths following vaccination: What does the evidence show?

Authors:  Elaine R Miller; Pedro L Moro; Maria Cano; Tom T Shimabukuro
Journal:  Vaccine       Date:  2015-05-23       Impact factor: 3.641

2.  Phase III, randomized controlled trial in girls 9-15 years old to evaluate lot consistency of a novel nine-valent human papillomavirus L1 virus-like particle vaccine.

Authors:  Alain Luxembourg; Edson D Moreira; Rudiwilai Samakoses; Kyung-Hyo Kim; Xiao Sun; Roger Maansson; Erin Moeller; Susan Christiano; Joshua Chen
Journal:  Hum Vaccin Immunother       Date:  2015       Impact factor: 3.452

Review 3.  The MMR Vaccine and Autism.

Authors:  Frank DeStefano; Tom T Shimabukuro
Journal:  Annu Rev Virol       Date:  2019-04-15       Impact factor: 10.431

Review 4.  Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).

Authors:  Tom T Shimabukuro; Michael Nguyen; David Martin; Frank DeStefano
Journal:  Vaccine       Date:  2015-07-22       Impact factor: 3.641

5.  Immunosignatures can predict vaccine efficacy.

Authors:  Joseph Barten Legutki; Stephen Albert Johnston
Journal:  Proc Natl Acad Sci U S A       Date:  2013-10-28       Impact factor: 11.205

6.  Production of avian influenza virus vaccine using primary cell cultures generated from host organs.

Authors:  Mustafeez Mujtaba Babar; Muhammad Suleman Riaz; Najam-us-Sahar Sadaf Zaidi; Farhan Afzal; Muhammad Sabir Farooq
Journal:  J Ind Microbiol Biotechnol       Date:  2013-03-21       Impact factor: 3.346

7.  Demonstrating vaccine effectiveness during a waning epidemic: A WHO/NIH meeting report on approaches to development and licensure of Zika vaccine candidates.

Authors:  Kirsten S Vannice; M Cristina Cassetti; Robert W Eisinger; Joachim Hombach; Ivana Knezevic; Hilary D Marston; Annelies Wilder-Smith; Marco Cavaleri; Philip R Krause
Journal:  Vaccine       Date:  2019-01-11       Impact factor: 3.641

Review 8.  Stem Cell Therapy: From Idea to Clinical Practice.

Authors:  Mohammad Mousaei Ghasroldasht; Jin Seok; Hang-Soo Park; Farzana Begum Liakath Ali; Ayman Al-Hendy
Journal:  Int J Mol Sci       Date:  2022-03-05       Impact factor: 5.923

9.  Frequency and Associations of Adverse Reactions of COVID-19 Vaccines Reported to Pharmacovigilance Systems in the European Union and the United States.

Authors:  Diego Montano
Journal:  Front Public Health       Date:  2022-02-03

Review 10.  Sustaining Vaccine Confidence in the 21st Century.

Authors:  Karin Hardt; Ruprecht Schmidt-Ott; Steffen Glismann; Richard A Adegbola; François P Meurice
Journal:  Vaccines (Basel)       Date:  2013-06-24
  10 in total

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