Evidence map›Paper›PMID 32864362›Full record

ReviewClinical and experimental vaccine research2020

Vaccines in the United States: a systematic review on history of evolution, regulations, licensing, and future challenges.

Sandeep Divate Sathyanarayana, Swapnil Dylan Fernandes, Lovely Joylen Castelino, Anoop Narayanan Vadakkepushpakath, Ravi Gundadka Shriram

Open access · diamondAbstract readReview
In one paragraph

Review in Clinical and experimental vaccine research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.2field-weighted citation impact, top 15% of its field
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 12 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 2 countries.

Sandeep Divate SathyanarayanaDepartment of Pharmaceutical Regulatory Affairs, Nitte Gulabi Shetty Memorial Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Mangaluru, India.ORCID https://orcid.org/0000-0002-4394-447X
Swapnil Dylan FernandesDepartment of Pharmaceutical Regulatory Affairs, Nitte Gulabi Shetty Memorial Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Mangaluru, India.ORCID https://orcid.org/0000-0003-4382-2701
Lovely Joylen CastelinoDepartment of Pharmaceutical Regulatory Affairs, Nitte Gulabi Shetty Memorial Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Mangaluru, India.ORCID https://orcid.org/0000-0003-1484-3570
Anoop Narayanan VadakkepushpakathDepartment of Pharmaceutical Regulatory Affairs, Nitte Gulabi Shetty Memorial Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Mangaluru, India.ORCID https://orcid.org/0000-0003-4352-7243
Ravi Gundadka ShriramResearch and Development, Neopharma LLC., Abu Dhabi, United Arab Emirates.ORCID https://orcid.org/0000-0001-9591-4742
Nitte University · INEmirates Foundation · AE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Vaccines are credited with reducing or effectively eradicating a number of infectious diseases such as smallpox, measles, and diphtheria. Particularly in nations like the United States, where a large number of infectious diseases were prevalent, vaccines proved to be timely interventions. The approval procedure for vaccines in the United States is regulated by the Center for Biologics Evaluation and Research. Vaccine development is often found to be demanding and requires astute knowledge and understanding of recent developments by physicians and researchers to ensure that effective vaccines are made available to the masses with minimum risk. This article aims to illustrate the regulatory scenario with regards to vaccine development and licensure in the United States with a brief look at the origin of vaccines and their regulations in the nation. Also, it details the challenges faced by the United States vaccine industry to remain relevant in today's constantly evolving world.

Indexed as

Center for Biologics Evaluation and ResearchCenters for Disease Control and PreventionPrescription Drug User Fee ActVaccineVaccine Adverse Event Reporting System

Identifiers

PMID32864362
PMCPMC7445324
OpenAlexW3080456165

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.