ArticleNPJ vaccines2016
First vaccine approval under the FDA Animal Rule.
Article in NPJ vaccines, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
32 citing papers in PubMed.
- Transcriptional analyses of peripheral blood lymphocytes obtained shortly after primary immunization discriminate vaccines againstInfection and immunity · 2026Article
- Alternative approaches to phase III clinical trials for vaccine efficacy and licensure: the role of real-world evidence - a meeting report.Biologicals : journal of the International Association of Biological Standardization · 2026Article
- A Framework for Assessing the Opportunity for Advanced Research, Development, and Regulatory Approval of Medical Countermeasures: A Component of BARDA's Emerging Infectious Diseases Strategy.The Journal of infectious diseases · 2026Article
- Realising the potential of correlates of protection for vaccine development, licensure and use: short summary.NPJ vaccines · 2024Article
- Accelerating antiviral drug discovery: lessons from COVID-19.Nature reviews. Drug discovery · 2023Review
- Approaches to demonstrating the effectiveness of filovirus vaccines: Lessons from Ebola and COVID-19.Frontiers in immunology · 2023Article
- Article
- Recent Advances in Genomics-Based Approaches for the Development of Intracellular Bacterial Pathogen Vaccines.Pharmaceutics · 2022Review
- Development of a Well-Characterized Cynomolgus Macaque Model of Sudan Virus Disease for Support of Product Development.Vaccines · 2022Article
- Working correlates of protection predict SchuS4-derived-vaccine candidates with improved efficacy against an intracellular bacterium, Francisella tularensis.NPJ vaccines · 2022Article
- Development of a Well-Characterized Cynomolgus Macaque Model of Marburg Virus Disease for Support of Vaccine and Therapy Development.Vaccines · 2022Article
- Natural History ofVaccines · 2022Article
- Understanding Vaccine Safety and the Roles of the FDA and the CDC.The New England journal of medicine · 2022Review
- Article
- Preclinical Animal Models for Q Fever Vaccine Development.Frontiers in cellular and infection microbiology · 2022Review
- Medical countermeasures against henipaviruses: a review and public health perspective.The Lancet. Infectious diseases · 2022Review
- Novel Transcriptional and Translational Biomarkers of Tularemia Vaccine Efficacy in a Mouse Inhalation Model: Proof of Concept.Microorganisms · 2021Article
- Antibiotic resistance modifying ability of phytoextracts in anthrax biological agent Bacillus anthracis and emerging superbugs: a review of synergistic mechanisms.Annals of clinical microbiology and antimicrobials · 2021Review
- Q Fever Vaccine Development: Current Strategies and Future Considerations.Pathogens (Basel, Switzerland) · 2021Review
- Modern Development and Production of a New Live Attenuated Bacterial Vaccine, SCHU S4Pathogens (Basel, Switzerland) · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
The US Food and Drug Administration's Animal Rule was established to facilitate licensure of new products for life-threatening conditions when traditional efficacy trials in humans are unethical or impractical. In November, 2015 BioThrax became the first vaccine to receive approval for a new indication via this pathway. The basis for this approval and use of Animal Rule or other non-traditional approval pathways for licensure of vaccines for serious conditions are discussed.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.